Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial
Recruitment status was Recruiting
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.
Procedure: External beam radiation
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial|
- PSA 3 and 6 months following implantation then every 6 months.
- Serum testosterone levels at 3 and 6 months in hormonally manipulated patients.
- Androgen deprivation therapy will not be reinitiated unless the post-treatment PSA exceeds 10 ng/mL or distant metastases are detected.
- EPIC on 6 and 12 months and then annually.
- Hormonally manipulated patients will obtain a DEXA scan.
- For documented osteoporosis, Zometa (4 mg IV over 15 minutes) every 3 months is recommended.
|Study Start Date:||August 2005|
|Estimated Study Completion Date:||August 2009|
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 with clinically localized and potentially curable disease, the selection of one local modality over another remains a focus of significant controversy within the uro-oncology community. However, patients with higher risk features are most often managed with radiotherapeutic approaches to include androgen deprivation therapy.
Prostate brachytherapy represents the ultimate-three dimensional conformal therapy and permits dose escalation far exceeding other modalities. Following permanent prostate brachytherapy with or without supplemental external beam radiation therapy, favorable long-term biochemical outcomes have been reported for patients with low, intermediate and high risk features with a morbidity profile that compares favorably with competing local modalities (1,2).
Several prospective randomized trials have demonstrated that androgen deprivation therapy in conjunction with conventional doses of external beam radiation therapy (65-70 Gy)results in improvement in disease-free and overall survival in patients with locally advanced prostate cancer (3,4).
|Contact: Gregory S. Merrick, MDfirstname.lastname@example.org|
|Contact: Kent E Wallner, MD||206-768-5356||Kent.Wallner@med.va.gov|
|United States, Washington|
|Groupe Health Cooperative, Veterans Adminstration Hospital and University of Washington||Recruiting|
|Seattle, Washington, United States, 98108|
|Contact: Kent E. Wallner, MD 206-768-5356 email@example.com|
|Seattle Prostate Institute||Recruiting|
|Seattle, Washington, United States, 98104|
|Contact: John Sylvester, MD 206-215-2480 firstname.lastname@example.org|
|United States, West Virginia|
|Schiffler Cancer Center||Recruiting|
|Wheeling, West Virginia, United States, 26003|
|Contact: Gregory S. Merrick, MD 304-243-3490 email@example.com|
|Contact: Robin Stipetich, RN, OCN 304-243-3490|
|Principal Investigator: Gregory S. Merrick, MD|
|Principal Investigator:||Gregory S Merrick, MD||Schiffler Cancer Center, Wheeling, WV|
|Study Chair:||Kent E. Wallner, MD||Group Health Cooperative, Veterans Administration Hospital, and University of Washington|
|Study Chair:||John Sylvester, MD||Seattle Prostate Institute Seattle, WA 98104|