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Hormone Therapy

Enzalutamide + M9241 for Recurrent Prostate Cancer

Phase 2

Recruiting

Led By Ravi A Madan, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Participants must be able to swallow tablets/capsules.

Measured or calculated creatinine clearance (CrCl) (estimated glomerular filtration rate (eGFR) may also be used in place of CrCl) > 45 mL/min/1.73 m^2 for participant with creatinine levels > 1.5 X institutional ULN

Must not have

Any medical condition that requires chronic systemic steroid therapy, or any other form of immunosuppressive medication (inhaled and topical steroids are permitted).

Evidence of soft tissue disease on CT scan (or magnetic resonance imaging (MRI) if assessment cannot be done by CT scan) per RECIST 1.1 criteria (section 6.3) (lymph nodes up to 2.0 cm in the shortest dimension are allowed).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests 2 drugs to treat prostate cancer that returned after treatment. Participants will visit clinic monthly, have tests & scans, and take pills/injections.

Who is the study for?

Men aged 18+ with recurrent prostate cancer after primary treatment, a rising PSA level, and PSMA PET/CT scan evidence of cancer. They must have adequate organ function, agree to contraception use post-treatment for 3 months, and be able to swallow pills. Excluded are those with certain other medical conditions or allergies related to the study drugs.

What is being tested?

The trial is testing enzalutamide (a daily pill) alone and combined with M9241 (a monthly injection), in men whose prostate cancer has returned. Participants will undergo cycles of treatment followed by regular clinic visits for monitoring up to five years.

What are the potential side effects?

Potential side effects may include reactions at the injection site from M9241, fatigue, changes in liver enzymes or blood counts due to enzalutamide or M9241, and possibly seizures as a rare but serious side effect.

Eligibility Criteria

Inclusion Criteria

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

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I can swallow pills.

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My kidney function, measured by creatinine clearance or eGFR, is above the required level.

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My hemoglobin level is at least 10 g/dL without transfusion help.

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I am 18 years old or older.

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I can do all my daily activities without help.

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My prostate cancer shows up on a special type of scan.

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I have had surgery or radiation for prostate cancer.

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This criterion does not provide enough information for a summary.

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My white blood cell count is healthy without needing medication.

Exclusion Criteria

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

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I am on long-term steroids or other drugs that weaken my immune system.

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My scans show cancer in soft tissues, meeting specific size criteria.

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I have had a seizure in the past 10 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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

Determine if the combination of enzalutamide and M9241 is associated with an increase in the duration of PSA suppression compared to that of enzalutamide alone

Secondary study objectives

Evaluate immune response

PET changes after enzalutamide with and without M9241 treatment

PSA detection

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