OncoMatch/Clinical Trials/NCT06397703
ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer
Is NCT06397703 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Leuprolide, Degarelix or Relugolix for prostate cancer.
Treatment: Leuprolide, Degarelix or Relugolix — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage T2C
Grade: Gleason 4+3Gleason 7 (Gleason)
Gleason 4+3 disease; Percent positive cores > 50% of Gleason 7 disease; 2-3 intermediate risk factors (Gleason 7; PSA 10-20 ng/mL; or T2b-T2c)
Prior therapy
Cannot have received: chemotherapy
Prior treatment for prostate cancer, including history of chemotherapy
Cannot have received: hormonal therapy
Exception: hormonal therapy within 30 days of enrollment
Prior treatment for prostate cancer, including...hormonal therapy within 30 days of enrollment
Cannot have received: surgery for prostate cancer
Exception: except for prior (transurethral resection of prostate) TURP or greenlight (photoselective vaporization of prostate) PVP which would be allowed
Prior treatment for prostate cancer, including...surgery for prostate cancer (except for prior (transurethral resection of prostate) TURP or greenlight (photoselective vaporization of prostate) PVP which would be allowed)
Lab requirements
Blood counts
ANC ≥ 1,500/mm3; platelets ≥ 100,000/mm3; hemoglobin > 9 g/dL (patients whose anemia has been corrected to > 9 g/dL with blood transfusions are allowed)
Kidney function
serum creatinine ≤ 1.5 x ULN
Liver function
serum bilirubin ≤ 1.5 x ULN, ALT and AST ≤ 2.5 x ULN; patients with Gilbert's syndrome may enroll if total bilirubin < 3 mg/dL with predominance of indirect bilirubin
Adequate hepatic function with serum bilirubin less than or equal to 1.5 times the upper institutional limits of normal (ULN), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to 2.5 x ULN. Patients with a history of Gilbert's syndrome may be enrolled if the total bilirubin is < 3 mg/dL with a predominance of indirect bilirubin; Adequate renal function with serum creatinine less than or equal to 1.5 x ULN; Adequate hematologic function with absolute neutrophil counts of at least 1,500 cell/mm3 and platelets of at least 100,000 cells/mm3 and hemoglobin value > 9 g/dL (Note: patients whose anemia has been corrected to a hemoglobin value > 9 g/dL with blood transfusions are allowed).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- NYU Langone Health · New York, New York
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