Not provided
Not provided
Not provided
Not provided
Not provided
poor accrual
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kent E. Wallner, M.D. | UNKNOWN |
| Sylvester, John, M.D. | INDIV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no hormones | Active Comparator | All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant with no hormones |
|
| 9 months of hormone therapy | Active Comparator | All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant with a 9 month course of hormone therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External beam radiation | Radiation | All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| PSA 3 and 6 months following implantation then every 6 months. | PSA 3 and 6 months following implantation then every 6 months. | 3 and 6 months following implantation then every 6 months |
| Serum testosterone levels at 3 and 6 months in hormonally manipulated patients. | Serum testosterone levels at 3 and 6 months in hormonally manipulated patients | 3 and 6 months |
| Androgen deprivation therapy will not be reinitiated unless the post-treatment PSA exceeds 10 ng/mL or distant metastases are detected. | Androgen deprivation therapy will not be reinitiated unless the post-treatment PSA exceeds 10 ng/mL or distant metastases are detected. | as needed |
| Measure | Description | Time Frame |
|---|---|---|
| EPIC on 6 and 12 months and then annually. | EPIC on 6 and 12 months and then annually. | 6 and 12 months and then annually. |
| Hormonally manipulated patients will obtain a DEXA scan. | Hormonally manipulated patients will obtain a DEXA scan. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gregory S Merrick, MD | Schiffler Cancer Center, Wheeling, WV | Principal Investigator |
| 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Prostate Institute | Seattle | Washington | 98104 | United States | ||
| Groupe Health Cooperative, Veterans Adminstration Hospital and University of Washington |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12686802 | Background | Merrick GS, Wallner KE, Butler WM. Permanent interstitial brachytherapy for the management of carcinoma of the prostate gland. J Urol. 2003 May;169(5):1643-52. doi: 10.1097/01.ju.0000035544.25483.61. | |
| 12126818 | Background | Bolla M, Collette L, Blank L, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Mattelaer J, Lopez Torecilla J, Pfeffer JR, Lino Cutajar C, Zurlo A, Pierart M. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet. 2002 Jul 13;360(9327):103-6. doi: 10.1016/s0140-6736(02)09408-4. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D016729 | Leuprolide |
| C053541 | bicalutamide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lupron | Drug | 9 months of an LHRH agonist and 4 months of an anti-androgen) is optimal for securing long-term biochemical control (a stable, non-rising PSA). |
|
| Casodex | Drug | 9 months of an LHRH agonist and 4 months of an anti-androgen) is optimal for securing long-term biochemical control (a stable, non-rising PSA). |
|
| as needed |
| For documented osteoporosis, Zometa (4 mg IV over 15 minutes) every 3 months is recommended. | For documented osteoporosis, Zometa (4 mg IV over 15 minutes) every 3 months is recommended. | every 3 months is recommended. |
| Seattle |
| Washington |
| 98108 |
| United States |
| Schiffler Cancer Center | Wheeling | West Virginia | 26003 | United States |
| 9060541 | Background | Pilepich MV, Caplan R, Byhardt RW, Lawton CA, Gallagher MJ, Mesic JB, Hanks GE, Coughlin CT, Porter A, Shipley WU, Grignon D. Phase III trial of androgen suppression using goserelin in unfavorable-prognosis carcinoma of the prostate treated with definitive radiotherapy: report of Radiation Therapy Oncology Group Protocol 85-31. J Clin Oncol. 1997 Mar;15(3):1013-21. doi: 10.1200/JCO.1997.15.3.1013. |
| 12743142 | Background | Roach M 3rd, DeSilvio M, Lawton C, Uhl V, Machtay M, Seider MJ, Rotman M, Jones C, Asbell SO, Valicenti RK, Han S, Thomas CR Jr, Shipley WS; Radiation Therapy Oncology Group 9413. Phase III trial comparing whole-pelvic versus prostate-only radiotherapy and neoadjuvant versus adjuvant combined androgen suppression: Radiation Therapy Oncology Group 9413. J Clin Oncol. 2003 May 15;21(10):1904-11. doi: 10.1200/JCO.2003.05.004. |
| 15315996 | Background | D'Amico AV, Manola J, Loffredo M, Renshaw AA, DellaCroce A, Kantoff PW. 6-month androgen suppression plus radiation therapy vs radiation therapy alone for patients with clinically localized prostate cancer: a randomized controlled trial. JAMA. 2004 Aug 18;292(7):821-7. doi: 10.1001/jama.292.7.821. |
| 15337535 | Background | Crook J, Ludgate C, Malone S, Lim J, Perry G, Eapen L, Bowen J, Robertson S, Lockwood G. Report of a multicenter Canadian phase III randomized trial of 3 months vs. 8 months neoadjuvant androgen deprivation before standard-dose radiotherapy for clinically localized prostate cancer. Int J Radiat Oncol Biol Phys. 2004 Sep 1;60(1):15-23. doi: 10.1016/j.ijrobp.2004.02.022. |
| 12614244 | Background | Merrick GS, Butler WM, Galbreath RW, Lief JH, Adamovich E. Does hormonal manipulation in conjunction with permanent interstitial brachytherapy, with or without supplemental external beam irradiation, improve the biochemical outcome for men with intermediate or high-risk prostate cancer? BJU Int. 2003 Jan;91(1):23-9. doi: 10.1046/j.1464-410x.2003.04024.x. |
| 15629591 | Background | Merrick GS, Butler WM, Wallner KE, Galbreath RW, Lief JH, Allen Z, Adamovich E. Impact of supplemental external beam radiotherapy and/or androgen deprivation therapy on biochemical outcome after permanent prostate brachytherapy. Int J Radiat Oncol Biol Phys. 2005 Jan 1;61(1):32-43. doi: 10.1016/j.ijrobp.2004.05.003. |
| 11872291 | Background | Lee LN, Stock RG, Stone NN. Role of hormonal therapy in the management of intermediate- to high-risk prostate cancer treated with permanent radioactive seed implantation. Int J Radiat Oncol Biol Phys. 2002 Feb 1;52(2):444-52. doi: 10.1016/s0360-3016(01)02598-6. |
| 15275720 | Background | Stock RG, Cahlon O, Cesaretti JA, Kollmeier MA, Stone NN. Combined modality treatment in the management of high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2004 Aug 1;59(5):1352-9. doi: 10.1016/j.ijrobp.2004.01.023. |
| 10851328 | Background | Sylvester J, Blasko JC, Grimm PD, Meier R, Goy B, Colburn G, Cavanagh W. Neoadjuvant Androgen Ablation Combined with External-Beam Radiation Therapy and Permanent Interstitial Brachytherapy Boost in Localized Prostate Cancer. Mol Urol. 1999;3(3):231-236. |
| 10798804 | Background | Merrick GS, Butler WM. Modified uniform seed loading for prostate brachytherapy: rationale, design, and evaluation. Tech Urol. 2000 Jun;6(2):78-84. |
| 9169810 | Background | Consensus statement: guidelines for PSA following radiation therapy. American Society for Therapeutic Radiology and Oncology Consensus Panel. Int J Radiat Oncol Biol Phys. 1997 Mar 15;37(5):1035-41. No abstract available. |
| 14630265 | Background | Wallner K, Merrick G, True L, Sutlief S, Cavanagh W, Butler W. 125I versus 103Pd for low-risk prostate cancer: preliminary PSA outcomes from a prospective randomized multicenter trial. Int J Radiat Oncol Biol Phys. 2003 Dec 1;57(5):1297-303. doi: 10.1016/s0360-3016(03)01448-2. |
| 11113727 | Background | Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology. 2000 Dec 20;56(6):899-905. doi: 10.1016/s0090-4295(00)00858-x. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |