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Hormone Therapy

Multi-arm Multi-modality Therapy for Prostate Cancer

University of Chicago, Chicago, IL
GnRH agonist/antagonist +6 morePhase 2RecruitingLed by Howard Scher, MDResearch Sponsored by Memorial Sloan Kettering Cancer Center

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.

Eligible Conditions
  • Prostate Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You can swallow pills or tablets as instructed.
You are okay with taking abiraterone acetate without food.
If you have sex with a pregnant woman while taking the study drug, you must use both a condom and another effective method of birth control, and continue to do so for 3 months after stopping the medication.


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

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
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4
Radical Prostatectomy
Completed Phase 2
Stereotactic Body Radiation Therapy
Completed Phase 2
Completed Phase 2
Abiraterone Acetate
Completed Phase 4

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,911 Previous Clinical Trials
588,839 Total Patients Enrolled
130 Trials studying Prostate Cancer
65,755 Patients Enrolled for Prostate Cancer
Dana-Farber Cancer InstituteOTHER
1,059 Previous Clinical Trials
339,887 Total Patients Enrolled
73 Trials studying Prostate Cancer
15,688 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 colitisg 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
~20 spots leftby Feb 2025