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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 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

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

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,678 Previous Clinical Trials

40,927,040 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,120 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research accommodating elderly participants?

"This clinical trial is inviting individuals aged 18 to 120 to participate in the study."

Answered by AI

How have the safety profiles of participants in Arm 1 been assessed?

"The safety of Arm 1 was determined to be a 2, as Phase 2 trials lack evidence that the treatment is efficacious but have some data suggesting its security."

Answered by AI

Who would be the ideal candidates for this research endeavor?

"This clinical trial is targeting 55 patients with prostate cancer of age between 18 and 120."

Answered by AI

Are there still opportunities to participate in this clinical trial?

"Based on clinicaltrials.gov, this specific medical study is not presently seeking candidates. The trial was posted on October 29th 2023 and the latest edit occured on October 23rd 2023; however, there are 2333 other trials actively recruiting participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enzalutamide and M9241 in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy

2024. "Enzalutamide and M9241 in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06096870.

All > Recurrent Prostate Cancer