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

Alternate Title

Radiation Therapy and Hormone Therapy in Treating Patients With Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed any age NCI RTOG-9413 RTOG-94-13, NCT00769548

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.

Entry 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)

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

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

Expected Enrollment

1,200 patients will be accrued over 2.5 years.

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.

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.

Taussky D, Bae K, Bahary JP, et al.: Does Timing of Androgen Deprivation Influence Radiation-Induced Toxicity? A Secondary Analysis of Radiation Therapy Oncology Group Protocol 9413. Urology : , 2008.[PUBMED Abstract]

Lawton CA, DeSilvio M, Roach M 3rd, et al.: 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 69 (3): 646-55, 2007.[PUBMED Abstract]

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.

Roach M 3rd, DeSilvio M, Valicenti R, et al.: 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 66 (3): 647-53, 2006.[PUBMED Abstract]

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 3rd, DeSilvio M, Lawton C, et al.: 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 21 (10): 1904-11, 2003.[PUBMED Abstract]

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.

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 71 (1): 316; author reply 316, 2008.[PUBMED Abstract]

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 71 (1): 315; author reply 315-6, 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.

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.

Ganswindt U, Paulsen F, Corvin S, et al.: Intensity modulated radiotherapy for high risk prostate cancer based on sentinel node SPECT imaging for target volume definition. BMC Cancer 5: 91, 2005.[PUBMED Abstract]

Roach M 3rd: The role of PSA in the radiotherapy of prostate cancer. Oncology (Huntingt) 10 (8): 1143-53; discussion 1154-61, 1996.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Mack Roach, MD, Protocol chair		Ph: 415-353-7175; 800-888-8664

Registry Information
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)
Registered in ClinicalTrials.gov		NCT00769548
Date Submitted to PDQ		1995-04-01
Information Last Verified		2008-07-11
NCI Grant/Contract Number		CA21661