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

Conditions

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

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PRL-02 injection — DRUG
  abiraterone decanoate for intramuscular injection
• prednisone — DRUG
  Oral dose
• dexamethasone — DRUG
  Oral dose
• enzalutamide — DRUG
  Oral capsule

Study Details

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.

Key Dates

Start date

Jun 14, 2021

Status verified

Feb 2026

Primary completion

May 31, 2029

Completion

May 31, 2029

Study Design

Enrollment

174 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1a Dose Escalation: Group A
  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.
• Experimental: Phase 1a Dose Escalation: Group B
  Participants with mCSPC, nmCSPC with biochemical relapse, or mCRPC will receive escalating doses of PRL-02 + dexamethasone.
• Experimental: Phase 1a Dose Escalation: Group H
  Participants with mCSPC or mCRPC will receive escalating doses of PRL-02 + dexamethasone + enzalutamide.
• Experimental: Phase 1b Dose Expansion: Group D
  Participants with mCRPC with prior treatment with abiraterone acetate will receive escalating doses of PRL-02 + dexamethasone.
• Experimental: Phase 1b Dose Expansion: Group E
  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.

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]

Central Contacts

• Astellas Pharma Global Development, Inc.
  800-888-7704
  [email protected]

Locations (24)

Find similar trials in Tucson, AZ

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