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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Evaluate immune response
PET changes after enzalutamide with and without M9241 treatment
PSA detection
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment2 Interventions
Enzalutamide+M9241
Group II: Arm 1Experimental Treatment1 Intervention
Enzalutamide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~2760

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,719 Previous Clinical Trials
40,963,503 Total Patients Enrolled
565 Trials studying Prostate Cancer
529,149 Patients Enrolled for Prostate Cancer
Ravi A Madan, M.D.Principal InvestigatorNational Cancer Institute (NCI)
17 Previous Clinical Trials
1,083 Total Patients Enrolled
11 Trials studying Prostate Cancer
921 Patients Enrolled for Prostate Cancer
~37 spots leftby Dec 2028