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Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial

Primary Objective Demonstrate that prophylactic neoadjuvant androgen deprivation therapy (NADT) and whole-pelvic radiation therapy (WPRT) will result in improvement in overall survival (OS) in patients with unfavorable intermediate risk or favorable high risk prostate cancer compared to NADT and high dose prostate and seminal vesicle (SV) radiation therapy (P + SV RT) using intensity modulated radiotherapy (IMRT) or EBRT with a high dose rate (HDR) or a permanent prostate (radioactive seed) implant (PPI) boost Secondary Objectives Demonstrate that prophylactic WPRT improves biochemical control ( Phoenix definition ). Patients not meeting these PSA criteria (Phoenix Definition) for failure who undergo salvage therapies (such as ADT, radical prostatectomy or brachytherapy, or Cryosurgery) should also be declared as failures at the time a positive biopsy is obtained or salvage therapy is administered, whichever comes first. Distant metastasis (DM) free-survival, defined as imaging documented evidence of distant spread of disease; Cause specific survival (CSS) will be defined as death from prostate cancer after biochemical failure followed by the development of metastatic disease followed by the development of castration resistant prostate cancer (CRPC). Compare acute and late treatment adverse events between patients receiving NADT + WPRT versus NADT + P & SV RT; Determine whether health related quality of life (HRQOL) as measured by the Expanded Prostate Cancer Index Composite (EPIC) significantly worsens with increasing aggressiveness of treatment (i.e. Arm 2, NADT + WPRT); Determine whether more aggressive treatment (Arm 2, NADT + WPRT) is associated with a greater increase in fatigue (PROMIS Fatigue Short Form) from baseline to last week of treatment and a greater increase in circulating inflammatory markers (IL-1, IL-1ra, IL-6, TNF-alpha, and C-reactive Protein); Demonstrate an incremental gain in OS and CSS with more aggressive therapy that outweighs any detriments in the primary generic domains of HRQOL (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression); this will be reported as the Quality Adjusted Freedom From Progression Year (QAFFPY) and as the Quality Adjusted Life Year (QALY); Determine whether changes in fatigue from baseline to the next three time points (week prior to radiation therapy, last week of treatment, and 3 months after treatment) are associated with changes in circulating cytokines, mood, sleep, and daily activities across the same time points. Collect paraffin-embedded tissue blocks, plasma, whole blood, and urine for planned and future translational research analyses.



Recruitment Status

Past Studies