NCT04729114ClinicalTrials.gov

A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer

Phase 1, Open-Label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced Prostate Cancer

RecruitingTaking participants now, according to the registry record.

Contact this study

In brief

Phase 1174 participants sought25 sites2 countries

Registered in 1 registry

ClinicalTrials.govNCT04729114Open this record at ClinicalTrials.govSynced 2 months ago

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Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2021-01-28; recorded start 2021-06-14
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Participants are not randomly assignedAllocation is recorded as non-randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 72 other studies in this databaseCounted from the lead sponsor named in the record (Astellas Pharma Global Development, Inc.)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 3 conditions.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a phase 1 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation0/20
Non-randomised allocation
Blinding0/20
Open-label
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 25 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleSMALL

A small study, international in scope: 174 participants (target), run at 25 sites, across 2 countries.

How this score is built

Enrolment21/40
174 participants (target)
Site count17/25
25 sites
Country count7/15
2 countries
Planned duration10/10
Planned over about 97 months
Sponsor scale7/10
Astellas Pharma Global Development, Inc. has led 67 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

Medicines that reduce the amount of testosterone in the body are commonly used to treat prostate cancer. PRL-02 depot is a potential treatment for men with advanced prostate cancer. It is given by an injection into the muscle. Men with advanced prostate cancer can take part in this study. Their cancer has come back after previous cancer treatment, or the previous cancer treatment they had didn't work. The main aims of the study are: * to check the safety of PRL-02 depot given with and without another medicine called enzalutamide. * to check if the men can tolerate PRL-02 depot given with or without enzalutamide. * to find a suitable dose of PRL-02 depot. This study will be in 2 parts. In the first part, different small groups of men will receive lower to higher doses of PRL-02 depot together with other medicines. In the second part of the study, men who have previously taken a hormone therapy called abiraterone acetate or have previously taken 1 specific hormone therapy as part of their prostate cancer treatment can take part. Men in both parts of the study will receive injections of PRL-02 depot into a muscle once every 12 weeks. They will also take dexamethasone or prednisone, or enzalutamide once a day. The other medicines they take depend on which group and which part of the study they are in. During the study, the men will visit the clinic several times for health checks and scans. After the final visit, men whose cancer has not become worse will continue to have health checks and scans every few months.

Conditions

Prostate Cancer
Metastatic Castration Resistant Prostate Cancer
Metastatic Castration-sensitive Prostate Cancer

Eligibility

Eligibility
Sex	Male
Ages	18 Years – No maximum
Healthy volunteers	No

Eligibility as written in the registry

Inclusion Criteria: * Histological evidence of adenocarcinoma of the prostate * Phase 1a Dose Escalation Groups A and B: participants must have one of the following documented conditions: * mCSPC (must have documentation by positive bone scan \[for bone disease\] or metastatic lesions on computed tomography \[CT\] or magnetic resonance imaging \[MRI\] scan \[for soft tissue\]) * nmCSPC with biochemical relapse of prostate cancer * mCSPC with oligometastatic prostate cancer (e.g., positron emission tomography positive) * mCRPC (must have documentation by positive bone scan \[for bone disease\] or metastatic lesions on CT or MRI scan \[for soft tissue\]) * NOTE: For participants in the Dose Escalation Cohorts (including backfill) at each of the dose levels up to approximately 10 participants with ARPI-naïve mCRPC who have not received prior treatment with an ARPI (e.g., abiraterone acetate, enzalutamide, apalutamide, darolutamide) will be enrolled. * Phase 1a Dose Escalation Groups A and B: participants with mCRPC must have evidence of disease progression defined as one or more of the following: * Evidence of radiographic progression of disease following the most recent prostate cancer treatment, defined as progressive disease on CT/MRI per RECIST v1.1 or on a bone scan per PCWG3. * PSA progression defined as the following: * PSA nadir is defined as the lowest PSA during or after the most recent treatment. PSA progression is defined as an increased PSA of at least 25% and ≥1 ng/mL above the nadir confirmed by at least 2 measurements with a minimum of 1 week apart, and with at least 1 of the measurements within 90 days prior to screening. * Participants with nmCSPC and biochemical recurrence, who had a radical prostatectomy (with or without radiotherapy) as the primary treatment for prostate cancer, must have a screening PSA ≥1 ng/mL. Participants with nmCSPC and biochemical recurrence who had radiotherapy only, as primary treatment for prostate cancer, must have a screening PSA ≥2 ng/mL above the nadir. * Phase 1b Expansion Groups D and E: participants must have mCRPC Participants in Group D must have received prior treatment with abiraterone acetate, but must not have received treatment with other ARPIs (enzalutamide, apalutamide or darolutamide). Participants in Group E must have received prior treatment with only 1 of the following ARPIs: enzalutamide, apalutamide or darolutamide. Participants in both Groups D and E must have documented evidence of progression with one or more of the following: * Evidence of radiographic progression of disease following the most recent prostate cancer treatment, defined as progressive disease on CT/MRI per RECIST v1.1 or on a bone scan per PCWG3. Disease spread that is limited to the regional pelvic lymph nodes does not qualify as radiographic progression. * PSA progression defined as the following: * PSA nadir is defined as the lowest PSA during or after the most recent treatment. PSA progression is defined as an increased PSA of at least 25% and ≥1 ng/mL above the nadir confirmed by at least 2 measurements with a minimum of 1 week apart, and with at least 1 of the measurements within 90 days prior to screening. * Participants with mCRPC must have undergone bilateral orchiectomy or received concurrent GnRH agonist or antagonist therapy for at least 6 weeks prior to the first dose of study drug. * Participants with mCSPC or nmCSPC with biochemical recurrence should have received \<6 months of ADT with a GnRH agonist or antagonist or have a history of bilateral orchiectomy (i.e., surgical or medical castration) within 6 months prior to Day 1. Castration therapy (i.e., medical or surgical) must have been started at least 14 days prior to Cycle 1 Day 1 and participants should have no radiographic evidence of disease progression or rising PSA levels after starting ADT and prior to Cycle 1 Day 1. * A serum testosterone level \<50 ng/dL at screening (for mCRPC participants only) * Adequate muscle mass for an i.m. injection * An ECOG PS of 0 or 1 * Adequate bone marrow reserve defined as: * Absolute neutrophil count (ANC) ≥1500/µL * Platelet count ≥100,000/µL * Hemoglobin ≥9 gm/dL * Adequate renal function defined as a serum creatinine ≤1.5 × upper limit of normal (ULN) for the reference laboratory or a calculated creatinine clearance ≥50 mL/min as determined by a validated algorithm for calculating creatinine clearance * Adequate hepatic function, defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN and total bilirubin ≤1.5 × ULN. Exception for elevated bilirubin secondary to Gilbert's disease. Confirmation of Gilbert's diagnosis requires: elevated unconjugated (indirect) bilirubin values; normal complete blood count in previous 12 months, blood smear, and reticulocyte count; normal aminotransferases and alkaline phosphatase in previous 12 months. * Serum albumin ≥3 gm/dL and serum potassium ≥3.5 mEq/L * Participants who are non-sterile and who are heterosexually active with a female partner of childbearing potential must be willing to use a highly effective means of contraception, such as a male condom plus spermicide, from the time of screening, throughout the total duration of the drug treatment, and until 12 weeks after the final dose of PRL-02 or enzalutamide (Group H). * Participant is able to comply with study requirements throughout the study. The Following Inclusion Criteria Apply to Dose Escalation Group H Only * Participants must have one of the following documented conditions: * mCSPC (must have documentation of a positive PMSA-PET or positive bone scan \[for bone disease\] or metastatic lesions on CT or MRI scan \[for soft tissue\]) * mCRPC (must have documentation of a positive PMSA-PET or positive bone scan \[for bone disease\] or metastatic lesions on CT or MRI scan \[for soft tissue\]) * NOTE: For participants in the Dose Escalation Cohorts (including backfill) at each of the dose levels, the Sponsor may elect to enroll up to 10 participants with ARPI-naïve mCRPC who have not received prior treatment with an ARPI (e.g., abiraterone acetate, enzalutamide, apalutamide, darolutamide). * Participants with mCRPC must have evidence of disease progression defined as one or more of the following: * Evidence of radiographic progression of disease following the most recent prostate cancer treatment, defined as progressive disease on CT/MRI per RECIST v1.1 or on a bone scan per PCWG3. * PSA progression defined as the following: * PSA nadir is defined as the lowest PSA during or after the most recent treatment. PSA progression is defined as an increased PSA of at least 25% and ≥1 ng/mL above the nadir confirmed by at least 2 measurements with a minimum of 1 week apart, and with at least 1 of the measurements within 90 days prior to screening. * Participant is able to swallow enzalutamide capsules whole. Exclusion Criteria: * Known active central nervous system (CNS) metastases. Note: Participants with CNS metastases that have been treated with surgery and/or radiation therapy, who are off pharmacologic doses of glucocorticoids, and who are neurologically stable are eligible. * Impending bone fracture due to bone metastases * Has a known additional malignancy beyond prostate cancer that required active treatment with the exception of any of the following: * Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ carcinoma of any type * Adequately treated Stage I cancer from which the participant is currently in remission and has been in remission for ≥2 years * Any other cancer from which the participant has been disease-free for ≥5 years * Clinically significant cardiac disease, defined as any of the following: * Clinically significant cardiac arrhythmias including bradyarrhythmia which are poorly controlled. * Congenital long QT syndrome * QT interval corrected by Fridericia's formula (QTcF) ≥450 msec at screening (based on average of triplicate ECGs at baseline). If the QT interval corrected for heart rate intervals (QTc) is prolonged in a participant with a pacemaker or bundle branch block, the participant may be enrolled in the study if confirmed by the Medical Monitor. * History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II or left ventricular ejection fraction measurement of \<50% at baseline. Participants must not have unstable angina (symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months \[NYHA Classification 2014\]. * Uncontrolled hypertension, defined as systolic blood pressure (BP) \>160 mmHg or diastolic BP \>100 mmHg which has been confirmed by 2 successive measurements despite optimal medical management. * Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the 3 months before start of study medication (except for adequately treated catheter-related venous thrombosis occurring \>1 month before the start of study medication). * Received an investigational drug within 4 weeks or 5 half-lives (whichever is shorter) of the first dose of study drug. * Received chemotherapy within 2 weeks or 5 half-lives (whichever is shorter) of the first dose of study drug. * Additional criteria: ARPI-naïve mCRPC participants enrolled in the Dose Escalation Cohorts (including backfill) must not have received prior chemotherapy in the mCRPC setting (prior receipt of chemotherapy in the mCSPC setting is allowed, if received at least 2 weeks or 5 half-lives prior to the first dose of study drug). * Any unresolved NCI CTCAE criteria v5.0 Grade \>2 toxicity from previous anticancer therapy at the Screening visit. Note: Participants receiving ongoing hormone replacement therapy for endocrine immune-related AEs without clinical symptoms will not be excluded. * Has not recovered from recent major surgery or trauma * Received a blood transfusion within 2 weeks of the first dose of study drug * History of impaired pituitary or adrenal gland function (e.g., Addison's disease, Cushing's syndrome) * Prior treatment with abiraterone acetate, orteronel. Exception: participants in Phase 1b Expansion Group D will have received prior abiraterone acetate, and participants in Group H may have received prior treatment with abiraterone acetate. * Current treatment with systemic ketoconazole or any other CYP17 inhibitor. Participants who have received systemic ketoconazole or any other CYP17 inhibitor must have discontinued these agents ≥4 weeks prior to the first dose of study drug. * Prior systemic treatment with an azole drug (e.g., fluconazole, itraconazole) within 4 weeks of first dose of study drug. * Prior treatment with estrogens within 12 weeks of the first dose of study drug * Need for systemic glucocorticoids greater than replacement doses; the use of topical, intraocular, inhalational, intranasal, or intra-articular glucocorticoids is permitted. * Prior use of any herbal products that could decrease PSA levels (e.g., saw palmetto) within 4 weeks of the first dose of study drug. Participants must agree not to use such herbal products during study participation. * Use of biotin (i.e., vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 µg \[NIH-ODS 2022\]. Note: Participants who switch from a high dose to a dose of 30 µg/day or less prior to first dose of study drug are eligible for study entry. * Required concomitant use of strong inducers of CYP3A4, except for enzalutamide given as study drug in Group H * Known hypersensitivity to PRL-02, abiraterone, abiraterone decanoate, prednisone, or dexamethasone or any of their excipients or components. * Has jaundice or known current active liver disease from any cause, including hepatitis A (hepatitis A virus immunoglobulin M \[IgM\] positive), hepatitis B (hepatitis B virus surface antigen \[HBsAg\] positive, confirmed by polymerase chain reaction \[PCR\]), or hepatitis C (hepatitis C virus \[HCV\] antibody positive, confirmed by HCV ribonucleic acid) * Hemoglobin A1c (HbA1c) \>10% in participants previously diagnosed with diabetes mellitus. HbA1c \>8% in participants whose diabetes mellitus is previously undiagnosed. (Excluded participants may be rescreened after referral and evidence of improved control of their condition). * Uncontrolled infection with human immunodeficiency virus (HIV)+. Exception: participants with well-controlled HIV (e.g., CD4 \>350/mm3 and undetectable viral load) are eligible. * Body mass index \>40 kg/m2 The Following Exclusion Criteria Apply to Dose Escalation Group H Only * Clinically significant cardiac disease, defined as any of the following: * NYHA class III or IV congestive heart failure or a history of NYHA class III or IV congestive heart failure, unless a screening echocardiogram or multigated acquisition scan performed within 3 months before the randomization date demonstrates a left ventricular ejection fraction of ≥45% * History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place * Hypotension as indicated by systolic BP \<86 mm Hg at screening * Bradycardia as indicated by a heart rate of ≤45 beats per minute on the screening ECG * Participant has a history of seizure or any condition that may predispose to seizure. * Use or required use of any prohibited medication. * Participant has a gastrointestinal disorder affecting absorption. * Participant has shown hypersensitivity reaction to the active pharmaceutical ingredient or any of the study capsule components, including Labrasol®, butylated hydroxyanisole, and butylated hydroxytoluene.

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Phase 1
Allocation	Non-randomised
Intervention model	SEQUENTIAL
Primary purpose	TREATMENT
Masking	NONE (0)
Enrolment	174 participants sought

Sponsor and collaborators

Astellas Pharma Global Development, Inc. Sponsor

Arms and interventions

Phase 1a Dose Escalation: Group AEXPERIMENTAL
Participants with metastatic castration-sensitive prostate cancer (mCSPC), nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical relapse, or metastatic castration-resistant prostate cancer (mCRPC) will receive escalating doses of PRL-02 + prednisone.
Phase 1a Dose Escalation: Group BEXPERIMENTAL
Participants with mCSPC, nmCSPC with biochemical relapse, or mCRPC will receive escalating doses of PRL-02 + dexamethasone.
Phase 1a Dose Escalation: Group HEXPERIMENTAL
Participants with mCSPC or mCRPC will receive escalating doses of PRL-02 + dexamethasone + enzalutamide.
Phase 1b Dose Expansion: Group DEXPERIMENTAL
Participants with mCRPC with prior treatment with abiraterone acetate will receive escalating doses of PRL-02 + dexamethasone.
Phase 1b Dose Expansion: Group EEXPERIMENTAL
Participants with mCRPC with prior treatment with 1 of the following androgen receptor pathway inhibitor (ARPIs) (enzalutamide, apalutamide, and/or darolutamide) will receive escalating doses of PRL-02 + dexamethasone.

Interventions

Drug PRL-02 injection
abiraterone decanoate for intramuscular injection
Drug dexamethasone
Oral dose
Drug enzalutamide
Oral capsule
Drug prednisone
Oral dose

Outcome measures

Primary outcome
Incidence of Dose Limiting Toxicities (DLTs)
A DLT is defined as any event meeting the DLT criteria during the first 28 days of each Dose Escalation treatment regardless of attribution to the study drug unless due to underlying disease or extraneous causes.
Time frame Up to 28 days
Primary outcome
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame Up to 4 years
Primary outcome
Number of Participants with Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other medically important events.
Time frame Up to 4 years
Primary outcome
Number of Participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Time frame Up to 4 years
Primary outcome
Number of Participants with electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with potentially clinically significant ECG values.
Time frame Up to 4 years
Primary outcome
Number of Participants with vital sign abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Time frame Up to 4 years
Primary outcome
Number of Participants with physical exam abnormalities and/or AEs
Number of participants with potentially clinically significant physical exam values or symptoms.
Time frame Up to 4 years
Primary outcome
Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status score
The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.
Time frame Up to 4 years
Primary outcome
Testosterone Suppression of Participants as Assessed by Testosterone Levels
Reduction in testosterone will be summarized by group and dose level.
Time frame Up to 4 years
Secondary outcome
Pharmacokinetics (PK) of Abiraterone in plasma: Maximum Concentration (Cmax)
Cmax will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone Decanoate in plasma: Cmax
Cmax will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone Metabolite in plasma: Cmax
Cmax will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone in plasma: Minimum Concentration (Cmin)
Cmin will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone Decanoate in plasma: Cmin
Cmin will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone Metabolite in plasma: Cmin
Cmin will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone in plasma: Time of maximum concentration (tmax)
tmax will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone Decanoate in plasma: tmax
tmax will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone Metabolite in plasma: tmax
tmax will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone in plasma: apparent volume of distribution (Vd/F)
Vd/F will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone Decanoate in plasma: Vd/F
Vd/F will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone Metabolite in plasma: Vd/F
Vd/F will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone in plasma: oral clearance (CL/F)
CL/F will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone Decanoate in plasma: CL/F
CL/F will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone Metabolite in plasma: CL/F
CL/F will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone in plasma: area under the curve from time 0 to the time of the last measurable concentration (AUClast)
AUClast will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone Decanoate in plasma: AUClast
AUClast will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone Metabolite in plasma: AUClast
AUClast will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone in plasma: Area Under the Concentration-time Curve from the Time of Dosing Extrapolated to Time Infinity (AUCinf)
AUCinf will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone Decanoate in plasma: AUCinf
AUCinf will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone Metabolite in plasma: AUCinf
AUCinf will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone in plasma: area under the plasma concentration-time curve during a dosage interval (AUCtau)
AUCtau will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone Decanoate in plasma: AUCtau
AUCtau will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone Metabolite in plasma: AUCtau
AUCtau will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone in plasma: Terminal Elimination Half-life (t1/2)
t1/2 will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone Decanoate in plasma: t1/2
t1/2 will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
PK of Abiraterone Metabolite in plasma: t1/2
t1/2 will be recorded from the PK plasma samples collected.
Time frame Up to 455 days
Secondary outcome
Composite Response Rate
Composite responses will be defined as meeting any one of the following criteria: Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with a minimum interval for confirmation of complete response (CR) or partial response (PR) of 4 weeks or; prostate specific antigen (PSA) decline of ≥50% confirmed by a second consecutive PSA assessment at least 3 weeks later, or; Conversion of circulating tumor cell (CTC) count to \<5 cells/7.5 mL blood nadir confirmed by an additional assessment at least 3 weeks later (for participants with a CTC count of ≥5 cells/7.5 mL blood at screening).
Time frame Up to 4 years
Secondary outcome
Best overall response (BOR) per RECIST v1.1
Time frame Up to 4 years
Secondary outcome
PSA decline of ≥50% response from baseline (PSA50)
Defined as ≥50% decline in PSA from baseline, confirmed by a second consecutive PSA assessment at least 3 weeks later.
Time frame Up to 4 years
Secondary outcome
PSA decline of ≥90% response from baseline (PSA90)
Defined as ≥90% decline in PSA from baseline, confirmed by a second consecutive PSA assessment at least 3 weeks later.
Time frame Up to 4 years
Secondary outcome
Percentage of participants achieving a PSA level <0.2 ng/mL
Time frame Up to 4 years
Secondary outcome
Duration of response (DOR)
DOR is defined as the length of time from date of first documented response using CTC count and/or PSA and/or RECIST v1.1 and Prostate Cancer Working Group 3 (PCWG3) until date of documented progression or death from any cause.
Time frame Up to 4 years
Secondary outcome
Radiographic progression-free survival (rPFS)
rPFS is defined as the time from first dose of study drug to documented progression or death using RECIST v1.1 or PCWG3.
Time frame Up to 4 years
Secondary outcome
Overall response rate (ORR) using RECIST v1.1
ORR is defined as percentage of patients with measurable disease at baseline who achieved a complete or partial response in their soft tissue disease using the RECIST v1.1 criteria.
Time frame Up to 4 years
Secondary outcome
Time to PSA progression
The time from first dose of study drug to documented PSA progression.
Time frame Up to 4 years
Secondary outcome
Overall survival (OS)
OS is defined as the time from the first dose of study drug to the date of death due to any cause.
Time frame Up to 4 years
Secondary outcome
Time to first symptomatic skeletal-related event (SSRE)
The time from first dose of study drug to first documented symptomatic skeletal-related event: Use of radiation therapy to prevent or relieve skeletal symptoms, occurrence of new symptomatic pathologic bone fractures (vertebral or nonvertebral) with radiologic documentation, occurrence of spinal cord compression with radiologic documentation, orthopedic surgical intervention for bone metastasis
Time frame Up to 4 years

Dates

Dates
Start date	June 14, 2021 (actual)
Primary completion	May 31, 2029 (estimated)
Completion	May 31, 2029 (estimated)
First posted	January 28, 2021 (actual)
Last updated	February 4, 2026
Results posted	Not stated in the registry record
Status last verified	February 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

15 sites are recruiting

Puerto Rico

Puerto Rico
Facility	City	State or region	Status
Pan American Center for Oncology Trials, LLC	San Juan	Rio Piedras	Recruiting

United States

United States
Facility	City	State or region	Status
New Mexico Oncology Hematology Consultants Ltd	Albuquerque	New Mexico	Recruiting
Los Angeles Cancer Network	Anaheim	California	Recruiting
MidLantic Urology	Bala-Cynwyd	Pennsylvania	Recruiting
National Cancer Institute	Bethesda	Maryland	Withdrawn
University of Virginia Cancer Center	Charlottesville	Virginia	Recruiting
Urology Clinics of North Texas	Dallas	Texas	Recruiting
Duke Cancer Center	Durham	North Carolina	Recruiting
Fort Wayne Medical Oncology and Hematology, Inc.	Fort Wayne	Indiana	Withdrawn
Oncology Consultants	Houston	Texas	Withdrawn
Houston Metro Urology	Houston	Texas	Recruiting
First Urology	Jeffersonville	Indiana	Recruiting
Helios Clinical Research, LLC	Middleburg Heights	Ohio	Withdrawn
Garden Sate Urology	Morristown	New Jersey	Withdrawn
Carolina Urologic Research Center	Myrtle Beach	South Carolina	Recruiting
Urology Associates PC	Nashville	Tennessee	Recruiting
XCancer Center Omaha/Urology Cancer Center	Omaha	Nebraska	Completed
Urology San Antonio	San Antonio	Texas	Withdrawn
Providence Medical Group Oncology Santa Rosa	Santa Rosa	California	Recruiting
Northwest Medical Specialties	Tacoma	Washington	Recruiting
Florida Urology Partners	Tampa	Florida	Withdrawn
Toledo Clinical Cancer Center	Toledo	Ohio	Withdrawn
Chesapeake Urology	Towson	Maryland	Recruiting
Arizona Urology Specialists	Tucson	Arizona	Withdrawn
Wichita Urology Group	Wichita	Kansas	Recruiting

Study documents

No documents are linked in this registry record.

Changes over time

No changes have been recorded since we first ingested this record.

A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT04729114

Categories

Registered in 1 registry

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How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

Puerto Rico

United States

Study documents

Changes over time