Open-label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced Prostate Cancer
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ClinicalTrials.gov Identifier: NCT04729114 |
Recruitment Status :
Recruiting
First Posted : January 28, 2021
Last Update Posted : March 4, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer mCRPC mCSPC | Drug: abiraterone decanoate | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 33 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | This is a 3+3 dose escalation study design with a dose expansion phase once a Phase 2 dose is identified. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open-label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced Prostate Cancer |
Actual Study Start Date : | June 14, 2021 |
Estimated Primary Completion Date : | December 31, 2023 |
Estimated Study Completion Date : | December 31, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Cohort 1
The starting dose will be 180 mg of PRL-02 depot (abiraterone decanoate for intramuscular injection)
|
Drug: abiraterone decanoate
PRL-02 depot (abiraterone decanoate for intramuscular injection) is a solution formulation of abiraterone decanoate at a concentration of 180 mg/mL and will be provided as a 10 mL vial containing 990 mg of abiraterone decanoate in 5.5 mL of solution. PRL-02 will be administered as an intramuscular injection every 84 days (+3 days) |
Experimental: Cohort 2
Cohort 2 dose will be 360 mg of PRL-02 depot (abiraterone decanoate for intramuscular injection)
|
Drug: abiraterone decanoate
PRL-02 depot (abiraterone decanoate for intramuscular injection) is a solution formulation of abiraterone decanoate at a concentration of 180 mg/mL and will be provided as a 10 mL vial containing 990 mg of abiraterone decanoate in 5.5 mL of solution. PRL-02 will be administered as an intramuscular injection every 84 days (+3 days) |
Experimental: Cohort 3
Cohort 3 dose will be 720 mg of PRL-02 depot (abiraterone decanoate for intramuscular injection)
|
Drug: abiraterone decanoate
PRL-02 depot (abiraterone decanoate for intramuscular injection) is a solution formulation of abiraterone decanoate at a concentration of 180 mg/mL and will be provided as a 10 mL vial containing 990 mg of abiraterone decanoate in 5.5 mL of solution. PRL-02 will be administered as an intramuscular injection every 84 days (+3 days) |
Experimental: Cohort 4
Cohort 4 dose will be 1260 mg of PRL-02 depot (abiraterone decanoate for intramuscular injection)
|
Drug: abiraterone decanoate
PRL-02 depot (abiraterone decanoate for intramuscular injection) is a solution formulation of abiraterone decanoate at a concentration of 180 mg/mL and will be provided as a 10 mL vial containing 990 mg of abiraterone decanoate in 5.5 mL of solution. PRL-02 will be administered as an intramuscular injection every 84 days (+3 days) |
Experimental: Dose Expansion
The recommended Phase 2a dose will be a dose from the cohort dose escalation phase that does not exceed the maximum tolerated dose and adequately suppresses serum testosterone (i.e., to less than or equal to 1 ng/dL) over the course of treatment. More than one dose may be selected for investigation in Phase 2a of the study.
|
Drug: abiraterone decanoate
PRL-02 depot (abiraterone decanoate for intramuscular injection) is a solution formulation of abiraterone decanoate at a concentration of 180 mg/mL and will be provided as a 10 mL vial containing 990 mg of abiraterone decanoate in 5.5 mL of solution. PRL-02 will be administered as an intramuscular injection every 84 days (+3 days) |
- Testosterone suppression [ Time Frame: Treatment ]To determine a preliminary recommended Phase 2 dose of PRL-02 depot that provides adequate testosterone suppression over the course of treatment.
- Safety and tolerability [ Time Frame: Treatment ]Reporting of number of patients with adverse events related to study drug

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Written informed consent obtained prior to any study-related procedure being performed.
- Male patients at least 18 years of age or older at time of consent.
- Histological evidence of adenocarcinoma of the prostate.
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Patients must have one of the following documented conditions:
- Metastatic castration sensitive prostate cancer (mCSPC);
- Castration sensitive prostate cancer (CSPC) with biochemical relapse (using the Prostate Cancer Working Group 3 [PCWG3] definition of PSA progression) of prostate cancer;
- Castration sensitive prostate cancer (CSPC) with oligometastatic prostate cancer (e.g., Positron Emission Tomography (PET) positive);
- Metastatic castration resistant prostate cancer (mCRPC) (only allowed in Phase 1 at the discretion of the Investigator and after a dose cohort that demonstrates adequate suppression of serum testosterone is determined.)
- Undergone orchiectomy or ongoing GnRH agonist or antagonist therapy for at least 1 month prior to the Screening Visit, AND a serum testosterone level <50 ng/dL but >2 ng/dL at screening.
Exclusion Criteria:
- Metastatic castration resistant prostate cancer (mCRPC) patients more than minimally symptomatic or with a reported pain score on an 11-point (0 - 10) numeric rating scale of >3 over the previous 7 days.
- Known active central nervous system (CNS) metastases. Patients 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.
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Clinically significant cardiac disease, defined as any of the following:
- Clinically significant cardiac arrhythmias including bradyarrhythmia and/or subjects who require anti-arrhythmic therapy (excluding beta blockers or digoxin). Subjects with controlled atrial fibrillation are not excluded.
- Congenital long QT syndrome
- QTcF ≥450 msec at Screening.
- History of clinically significant cardiac disease or congestive heart failure >New York Heart Association Class II or left ventricular ejection fraction measurement of <50% at baseline. Subjects 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.
- Uncontrolled hypertension, defined as systolic blood pressure >160 mmHg or diastolic blood pressure >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).
- Prior treatment with abiraterone, orteronel or current treatment with systemic ketoconazole or any other CYP17 inhibitor.
- Required concomitant use of strong inducers of CYP3A4 and substrates of CYP2C8 and CYP2D6.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04729114
Contact: Christine Mordy, MBA/MPH | 510-672-3620 | christine@consultingjw.com |
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Principal Investigator: Laurence M Belkoff | |
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Carolina Urologic Research Center | Recruiting |
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Contact: Jennifer Sutton, RN | |
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Urology Associates PC | Recruiting |
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Contact: David Morris, MD dmorris@ua-pc.com | |
Principal Investigator: David A Morris | |
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Urology San Antonio | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Clara De La Cruz 210-617-4116 | |
Contact: Emily Robb 12106174116 | |
Principal Investigator: Jose De La Cerda, MD |
Study Director: | Jackie Walling, MBChB, Ph.D | Consulting JW, LLC/Propella Therapeutics |
Responsible Party: | Propella Therapeutics |
ClinicalTrials.gov Identifier: | NCT04729114 |
Other Study ID Numbers: |
PRL-02-1001 |
First Posted: | January 28, 2021 Key Record Dates |
Last Update Posted: | March 4, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Testosterone prostate cancer Abiraterone Phase 1/2a mCSPC mCRPC Testosterone suppression |
metastatic castrate sensitive prostate cancer metastatic castrate resistant prostate cancer abiraterone decanoate propella therapeutics metastatic disease abiraterone acetate |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |