Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Procedure: External beam radiation Drug: Lupron Drug: Casodex |
Phase 3 |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 350 |
| 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).
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 Criteria:
- Exclusion criteria will be limited to patients who do not meet the above eligibility criteria.
Contacts and Locations| Contact: Gregory S. Merrick, MD | 304-243-3490 | gmerrick@urologicresearchinstitute.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 kent.wallner@med.va.gov | |
| Seattle Prostate Institute | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: John Sylvester, MD 206-215-2480 johnsylvester@seattleprostate.com | |
| United States, West Virginia | |
| Schiffler Cancer Center | Recruiting |
| Wheeling, West Virginia, United States, 26003 | |
| Contact: Gregory S. Merrick, MD 304-243-3490 gmerrick@urologicresearchinstitute.org | |
| 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 |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00243646 History of Changes |
| Other Study ID Numbers: | 05-8-4 |
| Study First Received: | October 20, 2005 |
| Last Updated: | May 20, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Schiffler Cancer Center:
|
Radiation therapy Brachytherapy Prostatic neoplasm |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Bicalutamide |
Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013