Status:
TERMINATED
Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial
Lead Sponsor:
Schiffler Cancer Center
Collaborating Sponsors:
Kent E. Wallner, M.D.
Sylvester, John, M.D.
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE3
Brief Summary
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 pati...
Detailed Description
In calender year 2005, 220, 000 men will be diagnosed with prostate cancer and approximately 30,000 will subsequently die of metastatic disease. Although the vast majority of men will be diagnosed wit...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Exclusion criteria will be limited to patients who do not meet the above eligibility criteria.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00243646
Start Date
August 1 2004
End Date
July 1 2009
Last Update
April 14 2016
Active Locations (3)
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1
Seattle Prostate Institute
Seattle, Washington, United States, 98104
2
Groupe Health Cooperative, Veterans Adminstration Hospital and University of Washington
Seattle, Washington, United States, 98108
3
Schiffler Cancer Center
Wheeling, West Virginia, United States, 26003