Hormone Therapy + Medications for Prostate Cancer

Palo Alto (17 mi)

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 primary tumor cannot be surgically removed.

I can swallow pills without any difficulty.

My prostate cancer has a Gleason score of 7 and an Oncotype score over 40.

I am a man aged 18 or older.

My prostate cancer is aggressive, based on Gleason score and tumor size.

My cancer has recently spread but only to a few places.

My prostate cancer came back after surgery, as shown on a PSMA PET scan.

I am fully active and can carry on all my pre-disease activities without restriction.

I am willing to take abiraterone acetate without eating.

Exclusion Criteria

I have a history of inflammatory bowel disease.

My liver is not working well.

I have been treated with medications targeting the AR signaling pathway.

My cancer has spread to my brain, liver, lungs, or other internal organs.

I have had treatments targeting the spread of my prostate cancer.

I have had issues with my pituitary or adrenal glands.

I have a serious heart condition.

I have another active cancer or was diagnosed with cancer in the last 2 years.

I need to take more than 10 mg of prednisone or prednisolone daily for a chronic condition.

I have received chemotherapy or biological therapy for prostate cancer.

I have a history of seizures or conditions that could lead to seizures.

My diabetes is not well-controlled.

Treatment Details

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