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ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer

NCT06397703 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2026-01-28

No results posted yet for this study

Summary

For this study, unfavorable intermediate risk prostate cancer patients will select whether they are to be treated with the standard of care (SOC) 6 months of Androgen Deprivation Therapy (ADT) in conjunction with stereotactic body radiation therapy/radiosurgery (SBRT) directed to the prostate versus SBRT alone. The patient population will include those with National Comprehensive Cancer Network (NCCN)-defined unfavorable intermediate risk disease. All patients will be followed every 6 months for up to 5 years from the first patient treated and will undergo a routine 24-30 months post-SBRT prostate biopsy to assess for local tumor control.

Conditions

Interventions

DRUG

Leuprolide, Degarelix or Relugolix

Patients assigned to the androgen deprivation therapy (ADT) arm will be treated with monthly Degarelix, or Leuprolide injections or daily Relugolix pills which are all standard ADT interventions.

RADIATION

Stereotactic body radiation therapy/radiosurgery (SBRT)

SBRT will be directed to the prostate and delivered with a prescription dose of 40 Gy in 5 fractions prescribed to the 95% isodose line encompassing the planning target volume. Intra-fraction motion targeting and target position corrections will be utilized for each of the 5 treatment fractions.

Sponsors & Collaborators

Principal Investigators

  • Michael Zelefsky · NYU Langone Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-16
Primary Completion
2030-04-16
Completion
2031-04-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06397703 on ClinicalTrials.gov