Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial
Stopped early · Phase 3
Conditions studied: Prostate Cancer
In brief
Determine the role of androgen deprivation therapy in high risk patients receiving 45 Gy of pelvic radiotherapy plus a Pd-103 boost and the impact of the duration of ADT in hormonally-manipulated patients.
Key facts
- Study ID
- NCT00243646
- Run by
- Schiffler Cancer Center
- People needed
- 6
- Starts
- 2004-08-01
- Expected to finish
- 2009-07-01
- Last updated by the study team
- 2016-04-14
Who can join
Age: any. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- High risk patients - Two to three of the following: PSA 10-30 ng/mL, Gleason score greater than or equal to 6, clinical stage greater than or equal to T2c (2002 ACJJ).
- CT of the abdomen and pelvis and bone scan without evidence of metastases.
- An enzymatic prostatic acid phosphatase must be obtained prior to randomization.
- A serum testosterone must be obtained prior to initiation of androgen deprivation therapy.
- No prior pelvic external beam radiation therapy for prostate cancer or other malignancies.
- No prior androgen deprivation therapy.
- Minimum 5 year life expectancy.
- No other invasive cancer diagnosis other than non-melanoma skin cancer within the last 5 years.
You may not qualify if…
- Exclusion criteria will be limited to patients who do not meet the above eligibility criteria.
Where it is running
- Seattle Prostate Institute — Seattle, Washington, United States
- Groupe Health Cooperative, Veterans Adminstration Hospital and University of Washington — Seattle, Washington, United States
- Schiffler Cancer Center — Wheeling, West Virginia, United States
Full record on ClinicalTrials.gov
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