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Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial
This study is currently recruiting participants.
Verified by Schiffler Cancer Center, May 2008
Sponsors and Collaborators: Schiffler Cancer Center
Kent E. Wallner, M.D.
Sylvester, John, M.D.
Information provided by: Schiffler Cancer Center
ClinicalTrials.gov Identifier: NCT00243646
  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 III

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Leuprolide acetate Leuprolide Bicalutamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title: Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial

Further study details as provided by Schiffler Cancer Center:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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
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 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243646

Contacts
Contact: Gregory S. Merrick, MD 304-243-3490 gmerrick@urologicresearchinstitute.org
Contact: Kent E Wallner, MD 206-768-5356 Kent.Wallner@med.va.gov

Locations
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            
Sponsors and Collaborators
Schiffler Cancer Center
Kent E. Wallner, M.D.
Sylvester, John, M.D.
Investigators
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:
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. Review.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Merrick GS, Butler WM. Modified uniform seed loading for prostate brachytherapy: rationale, design, and evaluation. Tech Urol. 2000 Jun;6(2):78-84. Review.
[No authors listed] 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.
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.
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.

Study ID Numbers: 05-8-4
Study First Received: October 20, 2005
Last Updated: May 20, 2008
ClinicalTrials.gov Identifier: NCT00243646  
Health Authority: United States: Institutional Review Board

Keywords provided by Schiffler Cancer Center:
Radiation therapy
Brachytherapy
Prostatic neoplasm

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Leuprolide
Bicalutamide
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 13, 2009