Ultra-hypofractionated Stereotactic Body Radiation Therapy with or without Short Course Degarelix in Treating Patients with Intermediate-Risk Prostate Cancer
- Biopsy proven intermediate risk prostate cancer, which includes patients with any one of the following variables: * Gleason 7 disease * Prostate-specific antigen (PSA) 10-20 ng/ml * Clinical T2b-T2c disease * Note: Patients who only have radiographic evidence of T3 disease (i.e. extracapsular extension, or seminal vesical invasion radiographically) will not be excluded
- Serum testosterone >= 240 ng/dL determined within 2 months prior to enrollment
- At least 4 weeks must have elapsed from major surgery
- Karnofsky performance status (KPS) >= 80%
- Prostate size as determined on magnetic resonance imaging (MRI) to be < 90 cc; prostate size can be determined on computed tomography (CT) scan if MRI is not available
- IPSS =< 20
- Patient must be available for follow-up; after 2 years of follow-up following post-treatment biopsy, telephone-based follow-up will be acceptable
- Serum bilirubin =< 1.5 times the upper institutional limits of normal (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 (within 8 weeks of randomization)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN (within 8 weeks of randomization)
- Serum creatinine =< 1.5 x ULN (within 8 weeks of randomization)
- Absolute neutrophil counts >= 1,500 cell/mm^3 (within 8 weeks of randomization)
- Platelets >= 100,000 cells/mm^3 (within 8 weeks of randomization)
- Hemoglobin value >= 9 g/dL (Note: patients whose anemia has been corrected to a hemoglobin value >= 9 g/dL with blood transfusions are allowed) (within 8 weeks of randomization)
- CT or MRI 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
- 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 prostatic resection [TURP] or greenlight photoselective vaporization of the prostate [PVP] which would be allowed)
- History of another malignancy within the previous 3 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
I. To compare 24-30 month post-stereotactic body radiation therapy (SBRT) prostate 12 core biopsy outcomes between intermediate risk patients treated with SBRT and short course androgen deprivation therapy (ADT) versus SBRT alone.
I. To assess whether the addition of 6 months of ADT with high dose SBRT decreases incident rates of biochemical failure and distant failure, or improves survival rate for intermediate risk prostate cancer patients compared to SBRT alone.
II. To assess the differences in short-term and long-term quality of life outcomes by comparing Expanded Prostate Cancer Index Composite (EPIC)-26, International Prostate Symptom Score (IPSS), and Short Form (SF)-12 survey results between intermediate risk prostate cancer patients treated with SBRT + short course ADT versus SBRT alone.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive degarelix subcutaneously (SC) every 28 days for 6 months in the absence of disease progression or unacceptable toxicity. Following 3 months of treatment with degarelix, patients undergo ultra-hypofractionated SBRT every other day (QOD) for 5 fractions.
ARM 2: Patients receive ultra-hypofractionated SBRT as in Arm 1.
After completion of study treatment, patients are followed up every 6 months for 2 years.
Trial Phase Phase III
Trial Type Treatment
Memorial Sloan Kettering Cancer Center
Michael J. Zelefsky
- Primary ID 16-1686
- Secondary IDs NCI-2017-00741
- Clinicaltrials.gov ID NCT03056638