What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as androgen deprivation therapy (ADT) and novel agents like abiraterone and enzalutamide, have several known side effects. ADT can cause hot flashes, fatigue, loss of libido, decreased muscle mass, mild anemia, cognitive changes, and osteoporosis. It also increases the risk of weight gain, diabetes, cardiac disease, and metabolic syndrome. Novel agents may lead to cardiovascular issues, peripheral edema, fatigue, and diarrhea. These side effects are crucial for patients to consider when undergoing treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, particularly focusing on androgen deprivation therapies (ADTs) and novel agents targeting specific pathways. Notable ADTs include enzalutamide and abiraterone acetate, which inhibit androgen receptor signaling and androgen synthesis, respectively. Additionally, the FDA has approved lutetium Lu 177 vipivotide tetraxetan for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) and radium-223 for bone metastases. These treatments aim to manage advanced stages of prostate cancer by targeting hormonal pathways and specific molecular targets.

What other types of research exist?

Promising alternatives to PRL-02 depot for prostate cancer treatment in 2024 include: 1) Relugolix, an oral gonadotropin-releasing hormone antagonist, which offers a convenient oral administration and has shown efficacy in advanced prostate cancer. 2) Enzalutamide combined with androgen deprivation therapy (ADT), which has demonstrated improved outcomes in castration-resistant prostate cancer (CRPC). 3) Beta-emitting radioisotopes like Ra-223, which have shown potential in reducing fractures and improving survival when combined with osteoclast inhibitors. 4) Bipolar androgen therapy (BAT), which has shown promise in restoring sensitivity to abiraterone and enzalutamide in CRPC patients.

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Other

PRL-02 Injection for Prostate Cancer

Phase 1

Recruiting

Research Sponsored by Astellas Pharma Global Development, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) of 0 or 1

Histological evidence of adenocarcinoma of the prostate, including metastatic castration sensitive prostate cancer (mCSPC); castration sensitive prostate cancer (CSPC); castration sensitive prostate cancer (CSPC); metastatic castration resistant prostate cancer (mCRPC)

Must not have

Known hypersensitivity to PRL-02, abiraterone, abiraterone decanoate, prednisone, or dexamethasone or any of their excipients or components.

Received chemotheapy within 2 weeks or 5 half-lives of Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a muscle injection called PRL-02 for patients with advanced prostate cancer. It aims to slowly release the medication to help manage the disease.

Who is the study for?

This trial is for men with advanced prostate cancer, including various stages and those who've had hormone therapy. Participants should be relatively fit (ECOG 0 or 1) and may have received certain other treatments like abiraterone or enzalutamide. Men with severe obesity, active heart disease, known allergies to the drugs being tested, uncontrolled diabetes, brain metastases not stable post-treatment, recent chemotherapy, current AR blockers use or estrogens in the last 3 months can't join.

What is being tested?

The study tests PRL-02 injections along with standard medications like prednisone and dexamethasone in men with advanced prostate cancer. It's an early-phase trial to see how well this new treatment works when given as a shot into the muscle. Some patients will also receive docetaxel infusions.

What are the potential side effects?

Possible side effects include reactions at the injection site for PRL-02; increased blood sugar levels from steroids like prednisone and dexamethasone; fatigue, nausea, hair loss from docetaxel infusion; plus general risks of infection due to immune system impact.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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My prostate cancer is sensitive or resistant to hormone therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to PRL-02, abiraterone, prednisone, dexamethasone, or their ingredients.

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I have not had chemotherapy within the last 2 weeks.

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I am taking medication that strongly affects liver enzyme levels.

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I have a serious heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Dose Limiting Toxicities (DLTs)

Number of Participants with Adverse Events (AEs)

Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status score

+6 more

Secondary study objectives

Composite Response Rate

Duration of response (DOR)

Overall response rate (ORR) using RECIST v1.1

+33 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Phase 1b Dose Expansion: Group EExperimental Treatment2 Interventions

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.

Group II: Phase 1b Dose Expansion: Group DExperimental Treatment2 Interventions

Participants with mCRPC with prior treatment with abiraterone acetate will receive escalating doses of PRL-02 + dexamethasone.

Group III: Phase 1a Dose Escalation: Group HExperimental Treatment3 Interventions

Participants with mCSPC or mCRPC will receive escalating doses of PRL-02 + dexamethasone + enzalutamide.

Group IV: Phase 1a Dose Escalation: Group BExperimental Treatment2 Interventions

Participants with mCSPC, nmCSPC with biochemical relapse, or mCRPC will receive escalating doses of PRL-02 + dexamethasone.

Group V: Phase 1a Dose Escalation: Group AExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

enzalutamide

2017

Completed Phase 4

~4530

prednisone

1999

Completed Phase 3

~10920

dexamethasone

1995

Completed Phase 3

~9520

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer, such as androgen deprivation therapy (ADT), work by reducing androgen levels or blocking androgen receptors, which are essential for the growth of prostate cancer cells. Novel agents, including PARP inhibitors and immune checkpoint inhibitors, target specific genetic mutations or boost the immune system's ability to fight cancer. These mechanisms are crucial for personalizing treatment plans based on a patient's unique genetic makeup and disease features, potentially leading to better outcomes and fewer side effects.