For this study, high risk prostate cancer patients with lower risk ARTERA scores will be treated with 6 months of Androgen Deprivation Therapy (ADT) in conjunction with dose escalated radiotherapy to the prostate and nodes. Specifically, patients enrolled in this study will undergo one of several dose-escalated forms of radiotherapy which would include SBRT with or without a brachytherapy boost.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
ADT will be delivered with monthly Degarelix, or Leuprolide injections or daily Relugolix pills which are all standard ADT interventions.
Dose-escalated radiotherapy.
NYU Langone Health
New York, New York, United States
RECRUITING5-Year Cumulative Incidence of Distant Metastases
Incidence of distant metastases (DM). DM is defined as the first occurrence of radiographic or biopsy-confirmed distant metastatic disease.
Time frame: Up to Year 5
Distant Metastasis-Free Survival (DMFS)
Defined as the time from study enrollment to the first occurrence of distant metastasis or death from any cause, whichever occurs first.
Time frame: Up to Year 5
Time to Biochemical Failure
Time to biochemical failure will be measured from study enrollment to the date when the Phoenix criterion (PSA nadir + 2 ng/mL) is first met.
Time frame: Up to Year 5
Overall Survival (OS)
Defined as the time from study enrollment to death from any cause.
Time frame: Up to Year 5
Change in Expanded Prostate Cancer Index Composite-26 (EPIC-26) Score
26-item survey assessing prostate cancer-related symptom domains. Each item is rated on a Likert score. The raw score is the sum of responses and is converted to a standard score from 0-100, where higher scores indicate greater quality of life.
Time frame: Baseline, Year 2
Change in International Prostate Symptom Score (IPSS) Score
7-item assessment of the severity of lower urinary tract symptoms linked to benign prostatic hyperplasia (BPH). Each item is rated on a Likert scale. The total score is the sum of responses and ranges from 0-35; lower scores indicate milder symptoms.
Time frame: Baseline, Year 2
Change in Short-Form-12 (SF-12) Score
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12-item assessment of health and quality of life. Each item is rated on a Likert scale. The raw score is the sum of responses and is converted to a standard score between 0-100; higher scores indicate better quality of life.
Time frame: Baseline, Year 2