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Hormone Therapy

Hormone Therapy + Medications for Prostate Cancer

Phase 2
Waitlist Available
Led By Howard Scher, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary tumor considered unresectable by RP based on initial imaging
Able to swallow the study drug(s) whole as a tablet
Must not have
History of inflammatory bowel disease
Baseline moderate and severe hepatic impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if treatment with medications that reduce the male hormone level can shrink prostate cancer and reduce the chances of the cancer coming back. The treatments include a hormone injection and the study drugs, which include abiraterone acetate, prednisone, and apalutamide.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include hormonal changes leading to hot flashes or sexual dysfunction, fatigue from anemia due to bone marrow suppression, liver function alterations from medication toxicity, potential digestive disturbances from pills taken orally.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My primary tumor cannot be surgically removed.
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I can swallow pills without any difficulty.
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My prostate cancer has a Gleason score of 7 and an Oncotype score over 40.
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I am a man aged 18 or older.
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My prostate cancer is aggressive, based on Gleason score and tumor size.
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My cancer has recently spread but only to a few places.
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My prostate cancer came back after surgery, as shown on a PSMA PET scan.
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I am fully active and can carry on all my pre-disease activities without restriction.
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I am willing to take abiraterone acetate without eating.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of inflammatory bowel disease.
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My liver is not working well.
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I have been treated with medications targeting the AR signaling pathway.
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My cancer has spread to my brain, liver, lungs, or other internal organs.
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I have had treatments targeting the spread of my prostate cancer.
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I have had issues with my pituitary or adrenal glands.
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I have a serious heart condition.
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I have another active cancer or was diagnosed with cancer in the last 2 years.
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I need to take more than 10 mg of prednisone or prednisolone daily for a chronic condition.
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I have received chemotherapy or biological therapy for prostate cancer.
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I have a history of seizures or conditions that could lead to seizures.
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My diabetes is not well-controlled.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Minimal residual disease (MRD)
Pathologic complete response
Secondary study objectives
PSA Response Rate
Time to PSA Progression

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~790
Radical Prostatectomy
2005
Completed Phase 2
~4550
Prednisone
2014
Completed Phase 4
~2500
Apalutamide
2015
Completed Phase 2
~5710
Abiraterone Acetate
2015
Completed Phase 4
~1880

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
597,149 Total Patients Enrolled
134 Trials studying Prostate Cancer
51,514 Patients Enrolled for Prostate Cancer
Dana-Farber Cancer InstituteOTHER
1,108 Previous Clinical Trials
357,135 Total Patients Enrolled
76 Trials studying Prostate Cancer
15,687 Patients Enrolled for Prostate Cancer
Howard Scher, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
36 Total Patients Enrolled

Media Library

GnRH agonist/antagonist (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03436654 — Phase 2
Prostate Cancer Research Study Groups: Apalutamide, SBRT, Radiation, ADT + Apalutamide + Abiraterone Acetate + Prednisone, ADT + Apalutamide
Prostate Cancer Clinical Trial 2023: GnRH agonist/antagonist Highlights & Side Effects. Trial Name: NCT03436654 — Phase 2
GnRH agonist/antagonist (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03436654 — Phase 2
~3 spots leftby Feb 2025
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