ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk 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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 5 years
- Procedures mentioned: Biopsies
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares focused radiation (SBRT) with or without 6 months of hormone treatment (ADT), which lowers male hormones. It is for people with prostate cancer in a group called unfavorable intermediate risk. Patients choose their treatment and have follow-up visits, including a prostate biopsy 24–30 months after radiation.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- A biopsy must show unfavorable intermediate-risk prostate cancer, based on the cancer grade, number of samples with cancer, PSA blood level, and tumor stage.
- Tumor tissue must be available for a Decipher test, which checks cancer genes. Results must be ready before treatment.
- Testosterone must be at least 150 ng/dL, tested within 2 months before joining.
- At least 4 weeks must have passed since major surgery. You must be able to do normal activities with some effort (KPS score of at least 80%).
- The prostate must be smaller than 90 cc on an MRI or CT scan. Your urinary symptom score (IPSS) must be 20 or less.
- You must be available for follow-up. Phone calls and medical record checks are allowed after 2 years and the follow-up biopsy.
- Liver and kidney blood tests must meet study limits. A special bilirubin limit applies to people with Gilbert's syndrome, a condition that raises bilirubin.
- Blood counts must meet these limits: neutrophils, a type of white blood cell, at least 1,500; platelets, which help blood clot, at least 100,000; and hemoglobin, which carries oxygen, above 9 g/dL. Blood transfusions to reach the hemoglobin level are allowed.
Who can't join
- Scans show cancer spread to bones or lymph nodes that are thought to contain cancer.
- Prior prostate cancer treatment, including chemotherapy, hormone treatment within 30 days before joining, or prostate cancer surgery. Prior TURP or GreenLight PVP procedures to remove prostate tissue are allowed.
- Another cancer within the past 2 years. Exceptions include adequately treated basal or squamous cell skin cancer, surface-level bladder cancer now in complete remission, or another cancer in complete remission for at least 3 years. Complete remission means no signs of cancer.
- Crohn's disease or ulcerative colitis, which cause swelling and irritation in the digestive tract.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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
Study sites (1)
NY
- NYU Langone Health · New York, NY 10016More trials in New York