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NCT05100472Active, not recruitingPhase 2

A Study of Shorter Course Hormone Therapy and Radiation for High-risk Prostate Cancer

Phase II Trial of Short Course Androgen Deprivation, Hypofractionated Pelvic Radiation and a Brachytherapy Boost for NCCN High-Risk Prostate Cancer With Low-Intermediate Risk Decipher Genomic Score

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to find out whether combining a shorter than standard course of ADT with standard prostate brachytherapy and hypofractionated external beam radiation therapy is a safe and effective way to prevent high-risk prostate cancer from coming back and/or spreading to other parts of the body.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
50 (actual)
First submitted
19 Oct 2021
Start date
19 Oct 2021
Primary completion date
19 Oct 2027
Lead sponsor
Memorial Sloan Kettering Cancer Center
NCT number
NCT05100472

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 50
  • From 19 Oct 2021 to the primary completion date, 19 Oct 2027
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior pelvic radiation
  • Prior prostate surgery (including TURP or cryosurgery)
  • Prior history of inflammatory bowel disease

Other illness

  • Regional lymph node or metastatic disease
  • Active second malignancy or past history of malignancies diagnosed within the last 2 years that requires active therapy and/or in remission, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancer

Other

  • Unable to undergo anesthesia or brachytherapy

Who the study is looking for

  • Pathologically-proven diagnosis of prostate adenocarcinoma
  • Clinical stage T3-4 or Gleason score 8-10 or PSA \>20 ng/ml
    • °If radiographic T3-T4 is the only high-risk factor, it must be "consistent with" or \>90% probability of having T3-T4 disease determined by the reading radiologist.
  • Decipher genomic score ≤0.6
  • Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization)
  • Age ≥18
  • KPS ≥70 or ECOG 0-2
  • Estimated life expectancy \>5 years
  • Baseline prostate volume ≤90 cc
  • Baseline IPSS ≤20
  • No contraindications to ADT, brachytherapy, or pelvic external beam radiation therapy as determined by the treating radiation oncologist per standard practice
  • Patients who have already started ADT consisting of bicalutamide 50 mg PO daily with leuprolide or an equivalent GnRH analogue are eligible if given for ≤ 60 days prior to registration

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Coordinator of this site? Confirm its status
Basking RidgeUnited StatesUnknown status
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Coordinator of this site? Confirm its status
CommackUnited StatesUnknown status
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Coordinator of this site? Confirm its status
HarrisonUnited StatesUnknown status
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Coordinator of this site? Confirm its status
MiddletownUnited StatesUnknown status
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Coordinator of this site? Confirm its status
MontvaleUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Coordinator of this site? Confirm its status
UniondaleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.