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Clinical Trials (PDQ®)

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Clinical Trials (PDQ®)

Phase III Randomized Trial of Long-Term Adjuvant Total Androgen Suppression with ZDX vs No Subsequent Treatment Following Neoadjuvant FLUT/ZDX and Radiotherapy for Locally Advanced Carcinoma of the Prostate. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Goserelin, Flutamine, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed50 and overNCIRTOG-9202
RTOG-92-02, NCT00767286

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.

Entry 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


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


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


Expected Enrollment

1,508 patients will be accrued over 2 years.

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.

Published Results

Khor LY, Bae K, Paulus R, et al.: MDM2 and Ki-67 predict for distant metastasis and mortality in men treated with radiotherapy and androgen deprivation for prostate cancer: RTOG 92-02. J Clin Oncol 27 (19): 3177-84, 2009.[PUBMED Abstract]

Pollack A, Bae K, Khor LY, et al.: The importance of protein kinase A in prostate cancer: relationship to patient outcome in Radiation Therapy Oncology Group trial 92-02. Clin Cancer Res 15 (17): 5478-84, 2009.[PUBMED Abstract]

Ray ME, Bae K, Hussain MH, et al.: Potential surrogate endpoints for prostate cancer survival: analysis of a phase III randomized trial. J Natl Cancer Inst 101 (4): 228-36, 2009.[PUBMED Abstract]

Efstathiou JA, Bae K, Shipley WU, et al.: Cardiovascular mortality and duration of androgen deprivation for locally advanced prostate cancer: analysis of RTOG 92-02. Eur Urol 54 (4): 816-23, 2008.[PUBMED Abstract]

Horwitz EM, Bae K, Hanks GE, et al.: 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 26 (15): 2497-504, 2008.[PUBMED Abstract]

Smith MR, Bae K, Efstathiou JA, et al.: Diabetes and mortality in men with locally advanced prostate cancer: RTOG 92-02. J Clin Oncol 26 (26): 4333-9, 2008.[PUBMED Abstract]

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, et al.: Prognostic value of p16 in locally advanced prostate cancer: a study based on Radiation Therapy Oncology Group Protocol 9202. J Clin Oncol 25 (21): 3082-9, 2007.[PUBMED Abstract]

Khor LY, Bae K, Pollack A, et al.: COX-2 expression predicts prostate-cancer outcome: analysis of data from the RTOG 92-02 trial. Lancet Oncol 8 (10): 912-20, 2007.[PUBMED Abstract]

Khor LY, Moughan J, Al-Saleem T, et al.: 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 13 (12): 3585-90, 2007.[PUBMED Abstract]

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, et al.: 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 69 (1): 79-87, 2007.[PUBMED Abstract]

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, et al.: Long-term hormone therapy and radiation is cost-effective for patients with locally advanced prostate carcinoma. Cancer 106 (1): 51-7, 2006.[PUBMED Abstract]

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, et al.: 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 66 (4): 1064-71, 2006.[PUBMED Abstract]

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, et al.: 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 22 (11): 2133-40, 2004.[PUBMED Abstract]

Hanks GE, Pajak TF, Porter A, et al.: 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 21 (21): 3972-8, 2003.[PUBMED Abstract]

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.

Related Publications

Du KL, Bae K, Movsas B, et al.: Impact of marital status and race on outcomes of patients enrolled in Radiation Therapy Oncology Group prostate cancer trials. Support Care Cancer 20 (6): 1317-25, 2012.[PUBMED Abstract]

Hamstra DA, Bae K, Pilepich MV, et al.: Older age predicts decreased metastasis and prostate cancer-specific death for men treated with radiation therapy: meta-analysis of radiation therapy oncology group trials. Int J Radiat Oncol Biol Phys 81 (5): 1293-301, 2011.[PUBMED Abstract]

Rodrigues G, Bae K, Roach M, et al.: Impact of ultrahigh baseline PSA levels on biochemical and clinical outcomes in two Radiation Therapy Oncology Group prostate clinical trials. Int J Radiat Oncol Biol Phys 80 (2): 445-52, 2011.[PUBMED Abstract]

Roach M 3rd, Bae K, Lawton C, et al.: Baseline serum testosterone in men treated with androgen deprivation therapy and radiotherapy for localized prostate cancer. Int J Radiat Oncol Biol Phys 78 (5): 1314-22, 2010.[PUBMED Abstract]

Roach M 3rd, Waldman F, Pollack A: Predictive models in external beam radiotherapy for clinically localized prostate cancer. Cancer 115 (13 Suppl): 3112-20, 2009.[PUBMED Abstract]

Rodrigues G, Bae K, Roach M, et al.: Impact of ultrahigh baseline PSA levels on biochemical and clinical outcomes in two Radiation Therapy Oncology Group (RTOG) prostate clinical trials. [Abstract] J Clin Oncol 27 (Suppl 15): A-5123, 2009.

Lawton CA, Bae K, Pilepich M, et al.: 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 70 (2): 437-41, 2008.[PUBMED Abstract]

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 54 (4): 823-4, 2008.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Gerald Hanks, MD, Protocol chair (Contact information may not be current)
Ph: 215-728-2940; 888-369-2427
Email: GE_Hanks@fccc.edu

Registry Information
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
Registered in ClinicalTrials.gov NCT00767286
Date Submitted to PDQ 1995-04-15
Information Last Verified 2013-05-08
NCI Grant/Contract Number CA21661

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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