← Back to Search

Hormone Therapy

Hormone Therapy + Medications for Prostate Cancer

Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
My primary tumor cannot be surgically removed.
Select...
I can swallow pills without any difficulty.
Select...
My prostate cancer has a Gleason score of 7 and an Oncotype score over 40.
Select...
I am a man aged 18 or older.
Select...
My prostate cancer is aggressive, based on Gleason score and tumor size.
Select...
My cancer has recently spread but only to a few places.
Select...
My prostate cancer came back after surgery, as shown on a PSMA PET scan.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Select...
I am willing to take abiraterone acetate without eating.

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

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

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
Prednisone
2014
Completed Phase 4
~2370
Radical Prostatectomy
2005
Completed Phase 2
~4550
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Apalutamide
2015
Completed Phase 2
~1510
Abiraterone Acetate
2015
Completed Phase 4
~1880

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,696 Total Patients Enrolled
131 Trials studying Prostate Cancer
65,792 Patients Enrolled for Prostate Cancer
Dana-Farber Cancer InstituteOTHER
1,076 Previous Clinical Trials
340,256 Total Patients Enrolled
76 Trials studying Prostate Cancer
16,003 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

Frequently Asked Questions

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

Is the enrollment process for this study still available to participants?

"As detailed on clinicaltrials.gov, this medical trial is currently in need of participants and has been since June 21st 2018. The information was last refreshed on June 28th 2022."

Answered by AI

How many sites are facilitating this research study?

"Currently, 11 clinical sites are facilitating this medical trial. These locations span from Cleveland to Harrison and Basking Ridge. To reduce the strain of travel on enrollees, potential participants should select a site closest to them."

Answered by AI

What other experiments have been conducted to evaluate the efficacy of Apalutamide?

"Apalutamide was first investigated at Providence Cancer Center in the year 2001. Since then, 781 studies have concluded and 425 are currently running; particularly in Cleveland, Ohio."

Answered by AI

What potential health risks are associated with Apalutamide?

"Apalutamide's safety has been documented in Phase 2 trials, so its risk score is a 2. No efficacy data exists yet to support the medication."

Answered by AI

What health issues is Apalutamide typically employed to address?

"Apalutamide has a range of medicinal applications, from managing cases of thyroiditis to treating prostate cancer non-metastatic and malignancies. It can also be used for ulcerative colitis relief."

Answered by AI

How many participants can be accommodated in this clinical experiment?

"Affirmative. According to information hosted on clinicaltrials.gov, this medical trial which began its recruitment in June 2018 is still actively searching for participants. 112 individuals are needed from 11 different hospitals and clinics."

Answered by AI
~14 spots leftby Feb 2025