Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT06397703

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

Led by NYU Langone Health · Updated on 2026-01-28

392

Participants Needed

1

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Biopsy proven unfavorable intermediate risk prostate cancer, including Gleason 4+3 disease, more than 50% positive cores of Gleason 7 disease, or 2-3 intermediate risk factors (Gleason 7; PSA 10-20 ng/mL; or T2b-T2c)
  • Tissue available for Decipher score testing with results before treatment start
  • Serum testosterone level of at least 150 ng/dL within 2 months prior to enrollment
  • At least 4 weeks since major surgery
  • Karnofsky Performance Scale score of 80% or higher
  • Prostate size less than 90 cc determined by MRI or CT if MRI unavailable
  • International Prostate Symptom Score (IPSS) of 20 or less
  • Availability for follow-up including post-treatment biopsy and long-term monitoring
  • Adequate liver function with bilirubin ≤ 1.5 times upper normal limit (or < 3 mg/dL with Gilbert's syndrome) and ALT/AST ≤ 2.5 times upper normal limit
  • Adequate kidney function with serum creatinine ≤ 1.5 times upper normal limit
  • Adequate blood counts with neutrophils ≥ 1500/mm3, platelets ≥ 100,000/mm3, and hemoglobin > 9 g/dL (corrected anemia allowed)
Not Eligible

You will not qualify if you...

  • Evidence of bone metastases on CT, MRI, or PET scans
  • Suspicious positive lymph nodes on MRI, CT, or PET scans
  • Prior treatments for prostate cancer including chemotherapy, hormonal therapy within 30 days, or surgery (except TURP or greenlight PVP)
  • History of other cancers within previous 2 years except treated basal cell or squamous cell skin cancer, superficial bladder cancer in remission, or any cancer in remission for at least 3 years
  • Diagnosis of Crohn's disease or ulcerative colitis

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

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Research Team

D

Dayna Leis, RN

CONTACT

N

Nina Yang, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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