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NCT03436654 · ClinicalTrials.gov registry record · Phase 2
Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma
A Phase 2 study of Prostate Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
- 11
- Study locations
NCT03436654: Active Phase 2 study of Prostate Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT03436654 is a Phase 2 study of Prostate Cancer that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 102 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (83% lower). The trial reports 11 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03436654, a Phase 2 study of Prostate Cancer, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
- 11
- Study locations
Study Summary
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.
Primary Outcome
The primary efficacy measure of pathological complete response (pCR) and minimal residual disease (MRD) is defined as the less than or equal to 5 mm of morphologically identifiable carcinoma in the RP specimen.
Conditions Studied
Interventions
- DRUG Apalutamide
- PROCEDURE Radical Prostatectomy
- DRUG Prednisone
- DRUG Abiraterone Acetate
- PROCEDURE Extended Pelvic lymphadenectomy
Study Locations (11)
New York
- Memorial Sloan Kettering Commack (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
Illinois
- University of Chicago - Chicago
- Northwestern University - Evanston
Massachusetts
- Dana Farber Cancer Institute - Boston
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2018-06-21 |
| Est. Completion | 2026-02-14 |
| Phase | Phase 2 |
What the registry record for NCT03436654 still lists
NCT03436654 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 5 interventions - of which Apalutamide is the first listed.
NCT03436654 lists 11 locations in 5 states (New York, New Jersey, Illinois).
Frequently Asked Questions
What is clinical trial NCT03436654 about?
NCT03436654 is a clinical study titled "Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma". 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 inc...
What is the current status of trial NCT03436654?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2018-06-21. Estimated completion is 2026-02-14.
What conditions does trial NCT03436654 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT03436654?
The interventions under investigation include: Apalutamide (DRUG), Radical Prostatectomy (PROCEDURE), Prednisone (DRUG), Abiraterone Acetate (DRUG), Extended Pelvic lymphadenectomy (PROCEDURE).
Who is sponsoring clinical trial NCT03436654?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03436654 being conducted?
This trial has 11 study locations across Illinois, Massachusetts, New Jersey, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03436654's enrollment target sits among peer trials
102 328th of 735 higher than 407 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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