Radiation Therapy and Hormone Therapy in Treating Patients With Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00769548
First received: October 8, 2008
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: flutamide
Drug: goserelin acetate
Radiation: low-LET photon therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A PHASE III TRIAL COMPARING WHOLE PELVIC IRRADIATION FOLLOWED BY A CONEDOWN BOOST TO BOOST IRRADIATION ONLY AND COMPARING NEOADJUVANT TO ADJUVANT TOTAL ANDROGEN SUPPRESSION (TAS)

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 1322
Study Start Date: April 1995
Primary Completion Date: April 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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 used for TAS.
Drug: goserelin acetate
Drug used for TAS.
Radiation: low-LET photon therapy
radiation therapy
Other Name: radiation therapy
Experimental: Arm 2
Neoadjuvant TAS given 2 months before and during RT to the prostate only.
Drug: flutamide
Drug used for TAS.
Drug: goserelin acetate
Drug used for TAS.
Radiation: low-LET photon therapy
radiation therapy
Other Name: radiation therapy
Experimental: Arm 3
RT to the whole pelvis followed by a boost to the prostate followed by 4 months of TAS.
Drug: flutamide
Drug used for TAS.
Drug: goserelin acetate
Drug used for TAS.
Radiation: low-LET photon therapy
radiation therapy
Other Name: radiation therapy
Experimental: Arm 4
RT to the prostate only followed by 4 months of TAS.
Drug: flutamide
Drug used for TAS.
Drug: goserelin acetate
Drug used for TAS.
Radiation: low-LET photon therapy
radiation therapy
Other Name: radiation therapy

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00769548

Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Mack Roach, MD University of California, San Francisco
  More Information

Additional Information:
Publications:
Speight JL: 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 Lawton CA, DeSilvio M, Roach M III, Uhl V, Kirsch R, Seider M, Rotman M, Jones C, Asbell S, Valicenti R, Hahn S, Thomas CR Jr., Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI. Urol Oncol 26 (4): 446-7, 2008.
Bahary J, Bae K, Taussky D, et al.: Does timing of androgen deprivation influence radiation-induced toxicity? A secondary analysis of Radiation Therapy Oncology Group protocol 9413. [Abstract] J Clin Oncol 24 (Suppl 18): A-4655, 2006.
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.
Lawton CA, DeSilvio M, Roach M, et al.: An update of the phase III trial comparing whole-pelvic (WP) to prostate only (PO) radiotherapy and neoadjuvant to adjuvant total androgen suppression (TAS): updated analysis of RTOG 94-13. [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-32, S19, 2005.
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.
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.
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.
Roach M III, Lu JD, Lawton C, et al.: A phase III trial comparing whole-pelvic (WP) to prostate only (PO) radiotherapy and neoadjuvant to adjuvant total androgen suppression (TAS): preliminary analysis of RTOG 9413. [Abstract] Int J Radiat Oncol Biol Phys 51 (3 suppl 1): Plenary A-5, 3, 2001.
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.
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.
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.
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.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00769548     History of Changes
Other Study ID Numbers: RTOG-9413, CDR0000063822
Study First Received: October 8, 2008
Last Updated: May 21, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Goserelin
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014