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Goserelin, Flutamine, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00767286
  Purpose

RATIONALE: Patient abstract not available

PURPOSE: Patient abstract not available


Condition Intervention Phase
Prostate Cancer
 Drug: flutamide
Drug: goserelin
Procedure: low-LET cobalt-60 gamma ray therapy
Procedure: low-LET photon therapy
 Phase III

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Goserelin Flutamide Cobalt
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A PHASE III TRIAL OF THE USE OF LONG TERM TOTAL ANDROGEN SUPPRESSION FOLLOWING NEOADJUVANT HORMONAL CYTOREDUCTION AND RADIOTHERAPY IN LOCALLY ADVANCED CARCINOMA OF THE PROSTATE

Further study details as provided by National Cancer Institute (NCI):

Detailed Description:

OBJECTIVES: I. Compare locoregional control, disease-free survival, and overall survival in patients with carcinoma of the prostate who are considered at high risk of relapse and receive long-term adjuvant zoladex (ZDX) vs. no adjuvant treatment following neoadjuvant ZDX/flutamide and radiotherapy. II. Compare sexual function in patients treated with these two regimens.

OUTLINE: Randomized study. Arm I: Neoadjuvant Antiandrogen Therapy and Releasing Factor Agonist Therapy plus Radiotherapy. Flutamide, FLUT, NSC-147834; and Zoladex, ZDX, NSC-606864; plus external-beam irradiation using megavoltage equipment with energies of at least 4 MV (at least 6 MV preferred). Arm II: Neoadjuvant Antiandrogen Therapy and Releasing Factor Agonist Therapy plus Radiotherapy followed by Adjuvant Releasing Factor Agonist Therapy. FLUT; and ZDX; plus external-beam irradiation using equipment as in Arm I; followed by ZDX.

PROJECTED ACCRUAL: 1,508 patients will be accrued over 2 years.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed, locally advanced adenocarcinoma of the prostate, including: Bulky primary tumors confined to the prostate (clinical Stage T2c) Primary tumors extending beyond the capsule (clinical Stage T3-4) No common iliac or para-aortic nodal involvement Regional lymph node involvement below the common iliac level allowed Positive nodes on imaging studies must be biopsied by FNA or surgical sampling PSA no more than 150 (mandatory) No distant metastases

PATIENT CHARACTERISTICS: Age: At least 50 Performance status: Karnofsky 70-100% Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No prior or concurrent second cancer except basal cell skin cancer No major medical or psychiatric illness that would prevent completion of treatment or interfere with follow-up

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No prior hormonal therapy Radiotherapy: No prior radiotherapy Surgery: No prior radical surgery for carcinoma of the prostate

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767286

Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Gerald E. Hanks, MD Fox Chase Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Efstathiou JA, Bae K, Shipley WU, Hanks GE, Pilepich MV, Sandler HM, Smith MR. Cardiovascular Mortality and Duration of Androgen Deprivation for Locally Advanced Prostate Cancer: Analysis of RTOG 92-02. Eur Urol. 2008 Oct;54(4):816-24. Epub 2008 Jan 15.
Horwitz EM, Bae K, Hanks GE, Porter A, Grignon DJ, Brereton HD, Venkatesan V, Lawton CA, Rosenthal SA, Sandler HM, Shipley WU. Ten-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer. J Clin Oncol. 2008 May 20;26(15):2497-504. Epub 2008 Apr 14.
Smith MR, Bae K, Efstathiou JA, Hanks GE, Pilepich MV, Sandler HM, Shipley WU. Diabetes and mortality in men with locally advanced prostate cancer: RTOG 92-02. J Clin Oncol. 2008 Sep 10;26(26):4333-9.
Smith MR, Kyounghwa B, Efstathiou JA, et al.: Diabetes and mortality in men with locally advanced prostate cancer: analyses of RTOG 92-02. [Abstract] J Clin Oncol 26 (Suppl 15): A-5013, 2008.
Chakravarti A, DeSilvio M, Zhang M, Grignon D, Rosenthal S, Asbell SO, Hanks G, Sandler HM, Khor LY, Pollack A, Shipley W; Radiation Therapy Oncology Group. Prognostic value of p16 in locally advanced prostate cancer: a study based on Radiation Therapy Oncology Group Protocol 9202. J Clin Oncol. 2007 Jul 20;25(21):3082-9.
Khor LY, Bae K, Pollack A, Hammond ME, Grignon DJ, Venkatesan VM, Rosenthal SA, Ritter MA, Sandler HM, Hanks GE, Shipley WU, Dicker AP. COX-2 expression predicts prostate-cancer outcome: analysis of data from the RTOG 92-02 trial. Lancet Oncol. 2007 Oct;8(10):912-20. Epub 2007 Sep 18.
Khor LY, Moughan J, Al-Saleem T, Hammond EH, Venkatesan V, Rosenthal SA, Ritter MA, Sandler HM, Hanks GE, Shipley WU, Pollack A. Bcl-2 and Bax expression predict prostate cancer outcome in men treated with androgen deprivation and radiotherapy on radiation therapy oncology group protocol 92-02. Clin Cancer Res. 2007 Jun 15;13(12):3585-90.
Ray ME, Bae K, Hussain MHA, et al.: Surrogate endpoints for prostate cancer survival: a secondary analysis of RTOG 9202. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-143, S81-82, 2007.
Roach M 3rd, De Silvio M, Rebbick T, Grignon D, Rotman M, Wolkov H, Fisher B, Hanks G, Shipley WU, Pollack A, Sandler H, Watkins-Bruner D. Racial differences in CYP3A4 genotype and survival among men treated on Radiation Therapy Oncology Group (RTOG) 9202: a phase III randomized trial. Int J Radiat Oncol Biol Phys. 2007 Sep 1;69(1):79-87. Epub 2007 May 10.
Hanks GE, Bae K, Porter AT, et al.: Ten year follow-up of RTOG 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-22, S13, 2006.
Khor L, Bae K, Hammond ME, et al.: Cox-2 overexpression predicts prostate cancer outcome: an analysis of RTOG 92-02. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-1124, S202, 2006.
Khor LY, Bae K, Hammond ME, et al.: COX-2 overexpression in pretreatment diagnostic tissue is associated with prostate cancer outcome in RTOG 92-02. [Abstract] Int J Biol Markers 22 (1): 73-4, 2006.
Konski A, Watkins-Bruner D, Brereton H, Feigenberg S, Hanks G. Long-term hormone therapy and radiation is cost-effective for patients with locally advanced prostate carcinoma. Cancer. 2006 Jan 1;106(1):51-7.
Pisansky TM, Bae K, Hanks GE, et al.: Temporal profile of serum testosterone with goserelin use and cessation: analysis of Radiation Therapy Oncology Group protocol 92-02. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-65, S38, 2006.
Pollack A, Moughan J, Khor L, et al.: Bcl-2 and Bax predict prostate cancer outcome in men treated with androgen deprivation and radiotherapy on RTOG 92-02. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-1123, S201, 2006.
Pollack A, Moughan J, Khor LY, et al.: BCL-2 and BAX are determinants of prostate cancer outcome in men treated with androgen deprivation and radiotherapy on RTOG 92-02. [Abstract] Int J Biol Markers 22 (1): 79, 2006.
Valicenti RK, DeSilvio M, Hanks GE, et al.: Post-treatment prostatic-specific antigen doubling time is a surrogate endpoint for prostate cancer-specific survival: an analysis of Radiation Therapy Oncology Group Protocol 92-02. [Abstract] 2006 Prostate Cancer Symposium, February 24-26, 2006, San Francisco, CA. A-270, 2006.
Valicenti RK, DeSilvio M, Hanks GE, Porter A, Brereton H, Rosenthal SA, Shipley WU, Sandler HM; Radiation Therapy Oncology Group Protocol 92-02. Posttreatment prostatic-specific antigen doubling time as a surrogate endpoint for prostate cancer-specific survival: an analysis of Radiation Therapy Oncology Group Protocol 92-02. Int J Radiat Oncol Biol Phys. 2006 Nov 15;66(4):1064-71. Epub 2006 Sep 18.
Chakravarti A, DeSilvio M, Zhang M, et al.: The prognostic value of p16 expression in locally advanced prostate cancer: a study based on RTOG 92-02. [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-30, S17, 2005.
Che M, DeSilvio M, Pollack A, et al.: Prognostic value of abnormal p53 expression in locally advanced prostate cancer treated with androgen deprivation and radiotherapy: a study based on RTOG 9202. [Abstract] American Society of Clinical Oncology 2005 Prostate Cancer Symposium, 17-19 February 2005, Orlando, Florida. A-62, 2005.
Pollack A, DeSilvio M, Khor L, et al.: MDM2 expression is independent of P53 and Ki-67 in predicting prostate cancer outcome: an analysis of RTOG 92-02. [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-29, S17, 2005.
Valicenti R, Desilvio M, Hanks G, et al.: Surrogate endpoint for prostate cancer-specific survival: validation from an analysis of Radiation Therapy Oncology Group Protocol 92-02. [Abstract] J Clin Oncol 23 (Suppl 16): A-4549, 390s, 2005.
Pollack A, DeSilvio M, Khor LY, Li R, Al-Saleem TI, Hammond ME, Venkatesan V, Lawton CA, Roach M 3rd, Shipley WU, Hanks GE, Sandler HM. Ki-67 staining is a strong predictor of distant metastasis and mortality for men with prostate cancer treated with radiotherapy plus androgen deprivation: Radiation Therapy Oncology Group Trial 92-02. J Clin Oncol. 2004 Jun 1;22(11):2133-40.
Hanks GE, Pajak TF, Porter A, Grignon D, Brereton H, Venkatesan V, Horwitz EM, Lawton C, Rosenthal SA, Sandler HM, Shipley WU; Radiation Therapy Oncology Group. Phase III trial of long-term adjuvant androgen deprivation after neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate: the Radiation Therapy Oncology Group Protocol 92-02. J Clin Oncol. 2003 Nov 1;21(21):3972-8. Erratum in: J Clin Oncol. 2004 Jan 15;22(2):386.
Pollack A, DeSilvio M, Khor L, et al.: Ki-67 staining is a strong predictor of patient outcome for prostate cancer patients treated with androgen deprivation plus radiotherapy: an analysis of RTOG 92-02. [Abstract] Int J Radiat Oncol Biol Phys 57 (2 Suppl): S200-1, 2003.
Sandler HM, Pajak TF, Hanks GE, et al.: Can biochemical failure (ASTRO definition) be used as a surrogate endpoint for prostate cancer survival in phase III localized prostate cancer clinical trials? Analysis of RTOG protocol 92-02. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1529, 2003.
Hanks GE, Lu JD, Machtay M, et al.: RTOG protocol 92-02: a phase III trial of the use of long term total androgen supppression following neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate. [Abstract] Int J Radiat Oncol Biol Phys 48 (3 suppl): A-4, 112, 2000.
Hanks GE, Lu J, Machtay M, et al.: RTOG protocol 92-02: a phase III trial of the use of long term androgen suppression following neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A1284, 2000.

Other Publications:
Lawton CA, Bae K, Pilepich M, Hanks G, Shipley W. Long-term treatment sequelae after external beam irradiation with or without hormonal manipulation for adenocarcinoma of the prostate: analysis of radiation therapy oncology group studies 85-31, 86-10, and 92-02. Int J Radiat Oncol Biol Phys. 2008 Feb 1;70(2):437-41. Epub 2007 Sep 19.
Lawton CA, Michalski J, El- Naqa I, et al.: RTOG: genitourinary radiation oncology specialists reach consensus on pelvic lymph node volumes for high risk prostate cancer. [Abstract] American Society of Clinical Oncology 2008 Genitourinary Cancers Symposium, Feb 14-16, 2008, San Francisco, CA. A-6, 2008.
Whelan P. Editorial Comment on: Cardiovascular Mortality and Duration of Androgen Deprivation for Locally Advanced Prostate Cancer: Analysis of RTOG 92-02. Eur Urol. 2008 Oct;54(4):823-4. Epub 2008 Jan 15. No abstract available.
Paner GP, Bae K, Grignon DJ, et al.: Trends in Gleason grading of prostate cancer (PCa): analysis of reporting by institutional and central review pathologists in four Radiation Therapy Oncology Group (RTOG) protocols spanning 17 years and 2094 needle biopsies (bxs). [Abstract] United States and Canadian Academy of Pathology 96th Annual Meeting, March 24-30, 2007, San Diego, CA. A-766, 2007.
Hachem P, Bae K, Khor L, et al.: Prostate tumor biomarker stability in archival tissue from men treated with radiotherapy: an analysis of RTOG 92-02 and Fox Chase randomized trials. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2280, S365-6, 2006.
Lawton CA, Bae K, Pilepich M, et al.: Long-term treatment sequelae following external beam irradiation + hormonal manipulation for adenocarcinoma of the prostate: analysis of RTOG studies 85-31, 86-10, and 92-02. [Abstract] 2006 Prostate Cancer Symposium, February 24-26, 2006, San Francisco, CA. A-191, 2006.
Pan CC, Bae K, Hanks GE, et al.: Comparison of two types of biochemical failures within the ASTRO and Phoenix Consensus definitions in patients treated on RTOG 92-02 and 94-13. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2196, S318, 2006.
Pollack A, Bae K, Khor LY, et al.: Stability of tumor biomarkers in archival tissue from men treated with radiotherapy for prostate cancer: an analysis of RTOG 92-02 and Fox Chase randomized trials. [Abstract] Int J Biol Markers 22 (1): 72-3, 2006.
Roach M, Moughan J, Movsas B, et al.: Socio-demographic predictors of biochemical failure and survival among high risk patients treated on Radiation Therapy Oncology Group (RTOG) prostate cancer trials: a meta-analysis. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-1127, S204, 2006.

Study ID Numbers: CDR0000077690, RTOG-9202
Study First Received: October 4, 2008
Last Updated: October 4, 2008
ClinicalTrials.gov Identifier: NCT00767286  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Cobalt
Goserelin
Urogenital Neoplasms
 Flutamide
Genital Diseases, Male
Prostatic Neoplasms
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents, Hormonal
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009



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