Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01368588|
Recruitment Status : Recruiting
First Posted : June 8, 2011
Last Update Posted : May 19, 2017
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells.
PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: radiation therapy Radiation: Whole-pelvic radiotherapy (WPRT)||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2580 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||July 2011|
|Estimated Primary Completion Date :||July 2027|
Active Comparator: Arm I
Patients undergo high-dose radiotherapy of the prostate and seminal vesicles using intensity-modulated radiotherapy (IMRT)* or 3D-conformal radiation therapy (3D-CRT)* once daily, 5 days a week, for approximately 9 weeks. Patients may also undergo permanent prostate implant (PPI) brachytherapy or high-dose rate brachytherapy (I 125 or Pd 103 may be used as the radioisotope).
Radiation: radiation therapy
Undergo RT using IMRT or 3D-CRT
Experimental: Arm II
Patients undergo whole-pelvic radiotherapy (WPRT)* (3D-CRT or IMRT) once daily, 5 days a week, for approximately 9 weeks. Patients may also undergo brachytherapy as in arm I.
Radiation: Whole-pelvic radiotherapy (WPRT)
Undergo whole-pelvic radiotherapy (WPRT)
- Overall Survival [ Time Frame: From date of randomization to the date of death. ]
- Cause-specific survival [ Time Frame: From date of randomization to the date of death due to prostate cancer. ]
- Distant metastasis-free survival [ Time Frame: From date of randomization to the date of first documented distant metastasis or date of first clinical and/or radiographic appearance of disseminated disease. ]
- Biochemical failure by the Phoenix definition (PSA ≥ 2 ng/mL over the nadir PSA) [ Time Frame: From date of randomization to the date of first biochemical failure by phoenix definition within 5 years of randomization. ]
- Incidence of "acute" adverse events as assessed by the Common Toxicity Criteria for Adverse Effects (CTCAE) current version [ Time Frame: From protocol treatment start date to the date of first occurrence of worst severity of the adverse event </= 30 days from completion of radiation therapy. ]
- Time to "late" grade 3+ adverse events as assessed by CTCAE current version [ Time Frame: From protocol treatment start date to the date of the first late grade 3+ adverse event occurring more than 30 days after the completion of radiation therapy. ]
- Prostate cancer-specific HRQOL change as measured by the EPIC-26 (bowel or urinary domain) [ Time Frame: Date when baseline EPIC-26 completed to 6 months post radiation therapy, 1 year post radiation therapy and 5 years post radiation therapy. ]
- Fatigue status as measured by the Patient-Reported Outcome Measurement Information System (PROMIS) fatigue-domain change score [ Time Frame: From the date when the baseline PROMIS is completed to the last week of treatment. ]
- Assessment and comparison of Quality Adjusted Life Years (QALYs) [ Time Frame: From the baseline QALYs assessment to the last week of radiation therapy (RT), 3 months post RT, 6 months post RT, 1 year post RT and 5 years post RT. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01368588
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|Principal Investigator:||Mack Roach, MD||University of California, San Francisco|