Hormone Therapy + Medications for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+13 other locations

Matthew Dallos, MD - MSK Genitourinary ...

Overseen byHoward Scher, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is to test if treatment with medications that reduce the male hormone level in the participant's body for a few months before surgery can shrink prostate cancer as much as possible, which might reduce the chances of the cancer coming back in the future. These treatments include a hormone injection given monthly or every three months and the study drugs, which include abiraterone acetate, prednisone, and apalutamide. These medications are being used in combination with surgery and maybe radiotherapy because studies have shown that any single approach on its own is not sufficient to control or get rid of the cancer especially if they have high risk or aggressive features. The researchers hope to learn if combining the study drugs with surgery and radiation will get rid of the cancer from participants' prostates and reduce their prostate-specific antigen (PSA) to an undetectable level.

Eligibility Criteria

Men over 18 with advanced prostate cancer, who can consent and have adequate organ function. They must not have other active cancers or major health issues that could interfere with the trial, no prior treatments for prostate cancer (with some exceptions), and agree to use effective contraception.

Inclusion Criteria

My liver, kidneys, and bone marrow are functioning well.

My primary tumor cannot be surgically removed.

I can swallow pills without any difficulty.

+14 more

Exclusion Criteria

Human immunodeficiency virus (HIV)-positive subjects with specific criteria

Concomitant therapy with any other experimental drug

Significant medical condition other than cancer that would prevent consistent and compliant participation in the study

+19 more

Participant Groups

The study tests if hormone reduction drugs before surgery can shrink prostate cancer effectively. It combines monthly hormone injections, abiraterone acetate, prednisone, apalutamide with surgery and possibly radiotherapy to see if this approach is more successful in eliminating cancer.

3Treatment groups

Experimental Treatment

Group I: Apalutamide, SBRT, RadiationExperimental Treatment2 Interventions

Group II: ADT + Apalutamide + Abiraterone Acetate + PrednisoneExperimental Treatment6 Interventions

This arm is no longer being assigned to subjects.

Group III: ADT + ApalutamideExperimental Treatment4 Interventions