Radiation Therapy and Hormone Therapy in Treating Patients With Prostate Cancer

NCT00769548 | Completed Phase 3 DMC

• 2 other identifiers: RTOG-9413CDR0000063822
• Study Type: interventional
• Target: 1,322
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (Arms 1, 3 vs. Arms 2, 4)

  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 (4)

• Progression-free survival (Arms 1, 2 vs. Arms 3, 4)

  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.

• Local progression

  From randomization to the date of local progression or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.

• Distant metastasis

  From randomization to the date of metastatic disease or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.

• Overall survival

  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.

Study Arms (4)

Arm 1

EXPERIMENTAL

Neoadjuvant total androgen suppression (TAS) given 2 months before and during radiation therapy (RT) to the whole pelvis followed by a prostate boost.

Drug: flutamide; Drug: goserelin acetate; Radiation: low-LET photon therapy

Arm 2

EXPERIMENTAL

Neoadjuvant TAS given 2 months before and during RT to the prostate only.

Drug: flutamide; Drug: goserelin acetate; Radiation: low-LET photon therapy

Arm 3

EXPERIMENTAL

RT to the whole pelvis followed by a boost to the prostate followed by 4 months of TAS.

Drug: flutamide; Drug: goserelin acetate; Radiation: low-LET photon therapy

Arm 4

EXPERIMENTAL

RT to the prostate only followed by 4 months of TAS.

Drug: flutamide; Drug: goserelin acetate; Radiation: low-LET photon therapy

Interventions

flutamide DRUG

Drug used for TAS.

Arm 1; Arm 2; Arm 3; Arm 4

goserelin acetate DRUG

Drug used for TAS.

Arm 1; Arm 2; Arm 3; Arm 4

low-LET photon therapy RADIATION

radiation therapy

Also known as: radiation therapy

Arm 1; Arm 2; Arm 3; Arm 4

Eligibility Criteria

• Age: Up to 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Related Publications (24)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Lawton CA, DeSilvio M, Roach M 3rd, Uhl V, Kirsch R, Seider M, Rotman M, Jones C, Asbell S, Valicenti R, Hahn S, Thomas CR Jr. 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. Int J Radiat Oncol Biol Phys. 2007 Nov 1;69(3):646-55. doi: 10.1016/j.ijrobp.2007.04.003. Epub 2007 May 24.

  PMID: 17531401 RESULT

• Taussky D, Bae K, Bahary JP, Roach M 3rd, Lawton CA, Shipley WU, Sandler HM. Does timing of androgen deprivation influence radiation-induced toxicity? A secondary analysis of radiation therapy oncology group protocol 9413. Urology. 2008 Nov;72(5):1125-9. doi: 10.1016/j.urology.2007.11.067. Epub 2008 Mar 7.

  PMID: 18314175 RESULT

• Roach M 3rd, DeSilvio M, Valicenti R, Grignon D, Asbell SO, Lawton C, Thomas CR Jr, Shipley WU. Whole-pelvis, "mini-pelvis," or prostate-only external beam radiotherapy after neoadjuvant and concurrent hormonal therapy in patients treated in the Radiation Therapy Oncology Group 9413 trial. Int J Radiat Oncol Biol Phys. 2006 Nov 1;66(3):647-53. doi: 10.1016/j.ijrobp.2006.05.074.

  PMID: 17011443 RESULT

• Taussky D, Bae K, Bahary J, et al.: Does testosterone influence radiation-induced toxicity In radiotherapy of the prostate? A secondary analysis of RTOG protocol 9413. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2215, S329-30.

  RESULT

• Roach M, DeSilvio M, Thomas C Jr, et al.: Field size and progression free survival (PFS) after neoadjuvant hormonal therapy (HT) and radiotherapy (RT) for prostate cancer: secondary analysis of RTOG 9413. [Abstract] American Society of Clinical Oncology 2005 Prostate Cancer Symposium, 17-19 February 2005, Orlando, Florida. A-87, 2005.

  RESULT

• Roach M, DeSilvio M, Thomas CR, et al.: Progression free survival (PFS) after whole-pelvic (WP) vs. mini-pelvic (MP) or prostate only (PO) radiotherapy (RT): a subset analysis of RTOG 9413, a phase III prospective randomized using neoadjuvant and concurrent (N&CHT). [Abstract] Int J Radiat Oncol Biol Phys 60 (Suppl 1): A-1014, S264, 2004.

  RESULT

• 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. doi: 10.1200/JCO.2003.05.004.

  PMID: 12743142 RESULT

• Roach M III, DeSilvio M, Lawton C, et al.: Neoadjuvant hormonal therapy (NHT) with whole-pelvic (WP) radiotherapy (RT) improves progression-free survival (PFS): RTOG (Radiation Therapy Oncology Group) 9413, a phase III randomized trial. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-711, 2002.

  RESULT

• Spratt DE, Tang S, Sun Y, Huang HC, Chen E, Mohamad O, Armstrong AJ, Tward JD, Nguyen PL, Lang JM, Zhang J, Mitani A, Simko JP, DeVries S, van der Wal D, Pinckaers H, Monson JM, Campbell HA, Wallace J, Ferguson MJ, Bahary JP, Schaeffer EM, Sandler HM, Tran PT, Rodgers JP, Esteva A, Yamashita R, Feng FY. Artificial Intelligence Predictive Model for Hormone Therapy Use in Prostate Cancer. NEJM Evid. 2023 Aug;2(8):EVIDoa2300023. doi: 10.1056/EVIDoa2300023. Epub 2023 Jun 29.

  PMID: 38320143 DERIVED

• Nguyen PL, Huang HR, Spratt DE, Davicioni E, Sandler HM, Shipley WU, Efstathiou JA, Simko JP, Pollack A, Dicker AP, Roach M, Rosenthal SA, Zeitzer KL, Mendez LC, Hartford AC, Hall WA, Desai AB, Rabinovitch RA, Peters CA, Rodgers JP, Tran P, Feng FY. Analysis of a Biopsy-Based Genomic Classifier in High-Risk Prostate Cancer: Meta-Analysis of the NRG Oncology/Radiation Therapy Oncology Group 9202, 9413, and 9902 Phase 3 Randomized Trials. Int J Radiat Oncol Biol Phys. 2023 Jul 1;116(3):521-529. doi: 10.1016/j.ijrobp.2022.12.035. Epub 2022 Dec 31.

  PMID: 36596347 DERIVED

• Spratt DE, Malone S, Roy S, Grimes S, Eapen L, Morgan SC, Malone J, Craig J, Dess RT, Jackson WC, Hartman HE, Kishan AU, Mehra R, Kaffenberger S, Morgan TM, Reichert ZR, Alumkal JJ, Michalski J, Lee WR, Pisansky TM, Feng FY, Shipley W, Sandler HM, Schipper MJ, Roach M 3rd, Sun Y, Lawton CAF. Prostate Radiotherapy With Adjuvant Androgen Deprivation Therapy (ADT) Improves Metastasis-Free Survival Compared to Neoadjuvant ADT: An Individual Patient Meta-Analysis. J Clin Oncol. 2021 Jan 10;39(2):136-144. doi: 10.1200/JCO.20.02438. Epub 2020 Dec 4.

  PMID: 33275486 DERIVED

• Roach M, Moughan J, Lawton CAF, Dicker AP, Zeitzer KL, Gore EM, Kwok Y, Seider MJ, Hsu IC, Hartford AC, Horwitz EM, Yamoah K, Jones CU, Michalski JM, Lee WR, Pisansky TM, Rabinovitch R, Rotman M, Pryzant RM, Kim HE, Thomas CR Jr, Shipley WU, Sandler HM. Sequence of hormonal therapy and radiotherapy field size in unfavourable, localised prostate cancer (NRG/RTOG 9413): long-term results of a randomised, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1504-1515. doi: 10.1016/S1470-2045(18)30528-X. Epub 2018 Oct 10.

  PMID: 30316827 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Flutamide; Goserelin; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Therapeutics

Study Officials

• Mack Roach, MD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: April 1, 1995
• Primary Completion: April 1, 2001
• Study Completion: December 1, 2016
• Last Updated: January 4, 2017

Record last verified: 2016-12