Comparing hormone therapy with radiation to radiation alone for prostate cancer
A Phase II Prospective 2-Arm Cohort Interventional Trial Utilizing Ultra-Hypofractionated SBRT With or Without Short Course Androgen Deprivation Therapy For Unfavorable Intermediate Risk Prostate Cancer
This study is testing whether adding hormone therapy to radiation treatment can help men with certain types of prostate cancer do better than just using radiation alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 392 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | NYU Langone Health Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06397703 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of combining six months of androgen deprivation therapy (ADT) with stereotactic body radiation therapy (SBRT) versus using SBRT alone in patients with unfavorable intermediate risk prostate cancer. Participants will be followed for up to five years to assess local tumor control through routine biopsies and clinical evaluations. The study aims to determine if the addition of ADT improves treatment outcomes for this specific patient population. Eligible patients must have specific characteristics defined by the National Comprehensive Cancer Network (NCCN).
Who should consider this trial
Good fit: Ideal candidates are men diagnosed with unfavorable intermediate risk prostate cancer who meet specific clinical criteria.
Not a fit: Patients with favorable risk prostate cancer or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes and better management of unfavorable intermediate risk prostate cancer.
How similar studies have performed: Other studies have explored similar combinations of ADT and radiation therapy, showing promising results, but this specific approach is being evaluated in a novel context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Biopsy proven unfavorable intermediate risk prostate cancer, which includes patients with any one of the following variables: 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) * Patients must have tissue available for Decipher score testing. Results must be available before start of treatment. * Serum testosterone ≥ 150 ng/dL determined within 2 months prior to enrollment * At least 4 weeks must have elapsed from major surgery * Karnofsky Performance Scale (KPS) ≥ 80% * Prostate size as determined on MRI to be \< 90 cc. Prostate size can be determined on CT scan if MRI is not available * IPSS ≤ 20 * Patient must be available for follow-up. After 2 years of follow-up, upon completion of post-treatment biopsy, telephone and chart review-based follow-up will be acceptable * 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). Exclusion Criteria: * CT or MRI or Positron Emission Tomography (PET) scan evidence of metastatic disease to the bone * Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT or PET scan * Prior treatment for prostate cancer, including history of chemotherapy, hormonal therapy within 30 days of enrollment or surgery for prostate cancer (except for prior (transurethral resection of prostate) TURP or greenlight (photoselective vaporization of prostate) PVP which would be allowed) * History of another malignancy within the previous 2 years except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, currently in complete remission, or any other cancer that has been in complete remission for at least 3 years * Patients with Crohn's disease or ulcerative colitis
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Michael Zelefsky — NYU Langone Health
- Study coordinator: Dayna Leis, RN
- Email: Dayna.Leis@nyulangone.org
- Phone: 347-266-2630
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.