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NCT00769548 · CITED IN SOURCE DOCUMENTS

Radiation Therapy and Hormone Therapy in Treating Patients With 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
2017-01-04

RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells. Hormone therapy combined with radiation therapy may be a more effective treatment for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of four different combinations of radiation and hormone therapy in treating patients with prostate cancer.

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 adenocarcinoma of the prostate Any stage with an estimated risk of node involvement at least 15% (and therefore at significant risk for local and/or systemic failure) based on pretreatment PSA and Gleason score (GS), e.g.: GS of 7 and PSA greater than 7.5 ng/mL GS of 6 and PSA greater than 22.5 ng/mL GS of 5 and PSA greater than 37.5 ng/mL PSA greater than 4 and less than 100 ng/mL Highest pretreatment value determined by a monoclonal assay that has a normal range of 0-4 ng/mL PSA measured by polyclonal assay (e.g., Yang) that has a normal range of 0-2.5 ng/mL may need to be divided by a conversion factor of approximately 1.5 GS determination required prior to entry No distant metastases No biopsy proven lymph node involvement Ineligible for protocol RTOG-9408 (clinical stages T2c-T4 with GS of 6 or higher are eligible for this study) PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70-100% Hematopoietic: Not specified Hepatic: Liver function tests no greater than 1.2 times normal Renal: Not specified Other: No major medical or psychiatric illness that would prevent completion of treatment or interfere with follow-up No second malignancy within 5 years except superficial nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: At least 90 days since testosterone At least 60 days since finasteride Radiotherapy: No prior radiotherapy Surgery: No more than 60 days since surgical staging No radical surgery or cryosurgery
healthy Volunteers
false
maximum Age
120 Years
sex
MALE
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Neoadjuvant total androgen suppression (TAS) given 2 months before and during radiation therapy (RT) to the whole pelvis followed by a prostate boost.
    intervention Names
    1. Drug: flutamide
    2. Drug: goserelin acetate
    3. Radiation: low-LET photon therapy
    label
    Arm 1
    type
    EXPERIMENTAL
  2. description
    Neoadjuvant TAS given 2 months before and during RT to the prostate only.
    intervention Names
    1. Drug: flutamide
    2. Drug: goserelin acetate
    3. Radiation: low-LET photon therapy
    label
    Arm 2
    type
    EXPERIMENTAL
  3. description
    RT to the whole pelvis followed by a boost to the prostate followed by 4 months of TAS.
    intervention Names
    1. Drug: flutamide
    2. Drug: goserelin acetate
    3. Radiation: low-LET photon therapy
    label
    Arm 3
    type
    EXPERIMENTAL
  4. description
    RT to the prostate only followed by 4 months of TAS.
    intervention Names
    1. Drug: flutamide
    2. Drug: goserelin acetate
    3. Radiation: low-LET photon therapy
    label
    Arm 4
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm 1
    2. Arm 2
    3. Arm 3
    4. Arm 4
    description
    Drug used for TAS.
    name
    flutamide
    type
    DRUG
  2. arm Group Labels
    1. Arm 1
    2. Arm 2
    3. Arm 3
    4. Arm 4
    description
    Drug used for TAS.
    name
    goserelin acetate
    type
    DRUG
  3. arm Group Labels
    1. Arm 1
    2. Arm 2
    3. Arm 3
    4. Arm 4
    description
    radiation therapy
    name
    low-LET photon therapy
    other Names
    1. radiation therapy
    type
    RADIATION
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
1322
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Progression-free survival (Arms 1, 3 vs. Arms 2, 4)
    time Frame
    From randomization to the first occurrence of biochemical failure, clinical failure (local or distant), death from any cause, or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.
secondary Outcomes
  1. measure
    Progression-free survival (Arms 1, 2 vs. Arms 3, 4)
    time Frame
    From randomization to the first occurrence of biochemical failure, clinical failure (local or distant), death from any cause, or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.
  2. measure
    Local progression
    time Frame
    From randomization to the date of local progression or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.
  3. measure
    Distant metastasis
    time Frame
    From randomization to the date of metastatic disease or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.
  4. measure
    Overall survival
    time Frame
    From the date of randomization to the date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.
Full study description
brief Summary
RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells. Hormone therapy combined with radiation therapy may be a more effective treatment for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of four different combinations of radiation and hormone therapy in treating patients with prostate cancer.
detailed Description
OBJECTIVES: I. Examine whether total androgen suppression (TAS) with flutamide/goserelin and whole-pelvic irradiation followed by a cone-down boost to the prostate improves progression-free survival at 5 years by at least 10% compared to TAS and prostate-only irradiation in patients with adenocarcinoma of the prostate at significant risk of nodal involvement. II. Examine whether induction and concurrent (neoadjuvant) TAS and radiotherapy improves the progression-free survival at 5 years by at least 10% compared to adjuvant TAS and radiotherapy. III. Compare treatments with regard to local control, time to distant failure, and overall survival. OUTLINE: Randomized study. Arm I: Neoadjuvant Antiandrogen Therapy with Radiotherapy. Flutamide, FLUT, NSC-147834; Goserelin, Zoladex, ZDX, NSC-606864; with irradiation of the whole pelvis followed by a boost to the prostate using photons of at least 6 MV. Arm II: Neoadjuvant Antiandrogen Therapy with Radiotherapy; FLUT; ZDX; with irradiation of the prostate using equipment as in Arm I. Arm III: Radiotherapy followed by Adjuvant Antiandrogen Therapy. Irradiation as in Arm I; followed by FLUT; ZDX. Arm IV: Radiotherapy followed by Adjuvant Antiandrogen Therapy. Irradiation as in Arm II; followed by FLUT; ZDX. PROJECTED ACCRUAL: 1,200 patients will be accrued over 2.5 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
    Millar J, Boyd R, Sutherland J. An update of the phase III trial comparing whole pelvic to prostate only radiotherapy and neoadjuvant to adjuvant total androgen suppression: updated analysis of RTOG 94-13, with emphasis on unexpected hormone/radiation interactions: in regard to Lawton et al. (Int J Radiat Oncol Biol Phys 2007;69:646-655.). Int J Radiat Oncol Biol Phys. 2008 May 1;71(1):316; author reply 316. doi: 10.1016/j.ijrobp.2008.01.009. No abstract available.
    pmid
    18406900
    type
    BACKGROUND
  6. citation
    Williams S, Wiltshire K. Updated analysis of RTOG 94-13: in regard to Lawton et al. (Int J Radiat Oncol Biol Phys 2007;69:646-655). Int J Radiat Oncol Biol Phys. 2008 May 1;71(1):315; author reply 315-6. doi: 10.1016/j.ijrobp.2008.01.021. No abstract available.
    pmid
    18406897
    type
    BACKGROUND
  7. 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
  8. 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
  9. citation
    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.
    type
    BACKGROUND
  10. citation
    Ganswindt U, Paulsen F, Corvin S, Eichhorn K, Glocker S, Hundt I, Birkner M, Alber M, Anastasiadis A, Stenzl A, Bares R, Budach W, Bamberg M, Belka C. Intensity modulated radiotherapy for high risk prostate cancer based on sentinel node SPECT imaging for target volume definition. BMC Cancer. 2005 Jul 28;5:91. doi: 10.1186/1471-2407-5-91.
    pmid
    16048656
    type
    BACKGROUND
  11. citation
    Johnke RM, Edwards JM, Evans MJ, Nangami GN, Bakken NT, Kilburn JM, Lee TK, Allison RR, Karlsson UL, Arastu HH. Circulating cytokine levels in prostate cancer patients undergoing radiation therapy: influence of neoadjuvant total androgen suppression. In Vivo. 2009 Sep-Oct;23(5):827-33.
    pmid
    19779119
    type
    BACKGROUND
  12. citation
    Roach M 3rd. The role of PSA in the radiotherapy of prostate cancer. Oncology (Williston Park). 1996 Aug;10(8):1143-53; discussion 1154-61.
    pmid
    8869957
    type
    BACKGROUND
Source notices and limitations
    Discovery and provenance
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        uninvolved pelvic lymph nodes does not appear to improve OS or prostate cancer-specific survival. </li></ul></div></li><li>RTOG-9413 (<a href="/clinicaltrials/NCT00769548">RTOG-9413</a> [NCT00769548]) trial.[<a href="#cit/section_5.30">30</a>,<a href="#cit/section_5.31">31</a>][<a href="/Common/PopUps/popDefinition.aspx?id=81002
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        rapy): </p> <div class="pdq-content-list"><ol id="_2045"><li>Although patients in the Radiation Therapy Oncology Group (RTOG) <a href="/clinicaltrials/NCT00769548">RTOG-9413</a> trial (NCT00769548) showed a 15% estimated risk of lymph node involvement and received whole-pelvic radiation therapy compared with prostate-on
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      1. context
        Updated: May 14, 2025
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    Preserved source evidence · Not medical advice