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NCT00767286 · CITED IN SOURCE DOCUMENTS

Goserelin, Flutamine, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2014-01-28

RATIONALE: Patient abstract not available PURPOSE: Patient abstract not available

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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
healthy Volunteers
false
minimum Age
50 Years
sex
MALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
interventions
  1. name
    flutamide
    type
    DRUG
  2. name
    goserelin acetate
    type
    DRUG
  3. name
    low-LET cobalt-60 gamma ray therapy
    type
    RADIATION
  4. name
    low-LET photon therapy
    type
    RADIATION
Study design
primary Purpose
TREATMENT
EnrollmentSource null
Registered outcome plans (not posted results)
Full study description
brief Summary
RATIONALE: Patient abstract not available PURPOSE: Patient abstract not available
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.
Source references
references
  1. citation
    Du KL, Bae K, Movsas B, Yan Y, Bryan C, Bruner DW. Impact of marital status and race on outcomes of patients enrolled in Radiation Therapy Oncology Group prostate cancer trials. Support Care Cancer. 2012 Jun;20(6):1317-25. doi: 10.1007/s00520-011-1219-4. Epub 2011 Jul 1.
    pmid
    21720747
    type
    BACKGROUND
  2. citation
    Hamstra DA, Bae K, Pilepich MV, Hanks GE, Grignon DJ, McGowan DG, Roach M, Lawton C, Lee RJ, Sandler H. 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. 2011 Dec 1;81(5):1293-301. doi: 10.1016/j.ijrobp.2010.07.2004. Epub 2011 Mar 31.
    pmid
    21458924
    type
    BACKGROUND
  3. citation
    Rodrigues G, Bae K, Roach M, Lawton C, Donnelly B, Grignon D, Hanks G, Porter A, Lepor H, Sandler H. 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. 2011 Jun 1;80(2):445-52. doi: 10.1016/j.ijrobp.2010.02.034. Epub 2010 Aug 24.
    pmid
    20615632
    type
    BACKGROUND
  4. citation
    Roach M 3rd, Bae K, Lawton C, Donnelly BJ, Grignon D, Hanks GE, Porter A, Lepor H, Venketesan V, Sandler H. Baseline serum testosterone in men treated with androgen deprivation therapy and radiotherapy for localized prostate cancer. Int J Radiat Oncol Biol Phys. 2010 Dec 1;78(5):1314-22. doi: 10.1016/j.ijrobp.2009.09.073. Epub 2010 Apr 8.
    pmid
    20378270
    type
    BACKGROUND
  5. citation
    Roach M 3rd, Waldman F, Pollack A. Predictive models in external beam radiotherapy for clinically localized prostate cancer. Cancer. 2009 Jul 1;115(13 Suppl):3112-20. doi: 10.1002/cncr.24348.
    pmid
    19544539
    type
    BACKGROUND
  6. citation
    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. doi: 10.1016/j.ijrobp.2007.06.050. Epub 2007 Sep 19.
    pmid
    17881145
    type
    BACKGROUND
  7. citation
    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.
    type
    BACKGROUND
  8. citation
    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. doi: 10.1016/j.eururo.2008.01.022. Epub 2008 Jan 15. No abstract available.
    pmid
    18243509
    type
    BACKGROUND
  9. citation
    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.
    type
    BACKGROUND
  10. citation
    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.
    type
    BACKGROUND
  11. citation
    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.
    type
    BACKGROUND
  12. citation
    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.
    type
    BACKGROUND
Source notices and limitations
    Discovery and provenance
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        androgen suppression therapy to EBRT may benefit men who are at an elevated risk of disease recurrence and death from prostate cancer (<a href="/clinicaltrials/NCT00767286">RTOG-9202</a> [NCT00767286]). </li></ol></div> </section> <section id="_2357"> <h4 id="_2357_toc">Interstitial implantation of radioisotop
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        to EBRT may benefit men who are at an elevated risk of disease recurrence and death from prostate cancer (<a href="/clinicaltrials/NCT00767286">RTOG-9202</a> [NCT00767286]). </li></ol></div> </section> <section id="_2357"> <h4 id="_2357_toc">Interstitial implantation of radioisotopes</h4> <p id="_2358
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        ed in improved biochemical DFS and cause-specific survival.[<a href="#cit/section_6.29">29</a>] </li><li>This finding was confirmed by <a href="/clinicaltrials/NCT00767286">RTOG-9202</a> (NCT00767286), which reported that radiation therapy plus 28 months of androgen deprivation resulted in longer 10-year disease-specific survival
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        FS and cause-specific survival.[<a href="#cit/section_6.29">29</a>] </li><li>This finding was confirmed by <a href="/clinicaltrials/NCT00767286">RTOG-9202</a> (NCT00767286), which reported that radiation therapy plus 28 months of androgen deprivation resulted in longer 10-year disease-specific survival rates (23% vs. 13%; <em>P</
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      source update dates
      1. context
        Updated: May 14, 2025
        datetime
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        display
        May 14, 2025

    Preserved source evidence · Not medical advice