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

Alternate Title

Radiation Therapy After Prostatectomy in Treating Patients With Stage III Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Completed any age NCI SWOG-8794 CAN-NCIC-PR2, CLB-9493, EST-9887, NCCTG-895251, RTOG-9019, INT-0086, NCT00394511, PR2

Objectives

I.  Compare disease-free survival rates of patients randomly assigned to 
adjuvant external-beam radiotherapy vs. no adjuvant therapy following radical 
prostatectomy and pelvic lymphadenectomy for surgical Stage C (T3 N0 M0) 
adenocarcinoma of the prostate.

II.  Determine the qualitative and quantitative toxicities associated with 
this adjuvant therapy.

Entry Criteria

Disease Characteristics:

Pathologically documented Stage C (T3 N0 M0) adenocarcinoma of the prostate
following radical prostatectomy and pelvic lymphadenectomy for clinical Stage
A/B disease

Ineligible for SWOG protocols of higher priority

At least 1 of the following on pathologic examination:
  Presence of cancer in the seminal vesicles
  Evidence of cancer at the inked surgical margin of the prostate
  Extension of tumor beyond the prostatic capsule

Negative preoperative metastatic survey within 6 months prior to registration,
including the following:
  Normal bone scan
  No palpable evidence of extraprostatic tumor extension

Bilateral lymph node dissection histologically negative for cancer
  Nodal sampling not required with the following stage/biopsy specimen Gleason
  score/preoperative PSA:
     Stage T1a/2-6/<10 ng/ml
     Stage T1b-c/2-5/<10 ng/ml
     Stage T2a/2-6/<10 ng/ml
     Stage T2b/2-6/<6 ng/ml
     Stage T2c/2-6/<4 ng/ml

Free from the following postoperative complications:
  Total urinary incontinence
  Intraoperative rectal injury
  Persistent urinary extravasation
  Pelvic infection

Concurrent registration on protocol SWOG-9205 (serum repository protocol)
optional

Concurrent registration on protocol SWOG-8994 (quality-of-life study) required
of English-speaking and Spanish-speaking patients enrolled by SWOG

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy for prostate cancer

Endocrine therapy:
  No more than 3 months of hormonal therapy prior to prostatectomy allowed

Radiotherapy:
  No prior radiotherapy for prostate cancer

Surgery:
  Radical prostatectomy and pelvic lymphadenectomy within 16 weeks prior to
  registration required

Patient Characteristics:

Age:
  Any age

Performance status:
  SWOG 0-2

Life expectancy:
  At least 2 years

Hematopoietic:
  WBC at least institutional LLN
  Platelets at least institutional LLN

Hepatic:
  SGOT no more than 2 x ULN

Renal:
  Not specified

Other:
  No second malignancy within 5 years except adequately treated
     nonmelanomatous skin cancer

Expected Enrollment

408 eligible patients will be entered over about 8.5 years.

Outline

Randomized study.  Randomization takes place when the patient is physically 
able to begin treatment, any time within 16 weeks after surgery.

Arm I:  Radiotherapy.  Irradiation of the prostatic bed using megavoltage 
equipment with effective photon energies of greater than 4 MV.

Arm II:  No further treatment.

Moinpour CM, Hayden KA, Unger JM, et al.: Health-related quality of life results in pathologic stage C prostate cancer from a Southwest Oncology Group trial comparing radical prostatectomy alone with radical prostatectomy plus radiation therapy. J Clin Oncol 26 (1): 112-20, 2008.[PUBMED Abstract]

Swanson GP, Goldman B, Tangen CM, et al.: The Prognostic Impact of Seminal Vesicle Involvement Found at Prostatectomy and the Effects of Adjuvant Radiation: Data From Southwest Oncology Group 8794. J Urol : , 2008.[PUBMED Abstract]

Swanson GP, Hussey MA, Tangen CM, et al.: Predominant treatment failure in postprostatectomy patients is local: analysis of patterns of treatment failure in SWOG 8794. J Clin Oncol 25 (16): 2225-9, 2007.[PUBMED Abstract]

Swanson GP, Hussey MA, Thompson IM, et al.: Pre radiation PSA predicts for outcome of adjuvant radiation in SWOG 8794. [Abstract] American Urological Association: Annual Meeting, May 20-25, 2006, Atlanta, GA A-668, 2006.

Thompson IM Jr, Tangen CM, Paradelo J, et al.: Adjuvant radiotherapy for pathologically advanced prostate cancer: a randomized clinical trial. JAMA 296 (19): 2329-35, 2006.[PUBMED Abstract]

Swanson GP, Thompson IM, Tangem C, et al.: Phase III randomized study of adjuvant radiation therapy versus observation in patients with pathologic T3 prostate cancer (SWOG 8794). [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-1, S1, 2005.

Ganswindt U, Stenzl A, Bamberg M, et al.: Adjuvant Radiotherapy for Patients with Locally Advanced Prostate Cancer-A New Standard? Eur Urol : , 2008.[PUBMED Abstract]

Thompson IM, Paradelo JC, Crawford ED, et al.: An opportunity to determine optimal treatment of pT3 prostate cancer: the window may be closing. Urology 44 (6): 804-11, 1994.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Ian Thompson, MD, Protocol chair		Ph: 210-567-5643 Email: thompsoni@uthscsa.edu

Eastern Cooperative Oncology Group

Edward Messing, MD, FACS, Protocol chair		Ph: 585-275-3345 Email: edward_messing@urmc.rochester.edu

NCIC-Clinical Trials Group

Joseph Chin, MD, Protocol chair		Ph: 519-685-8451 Email: JCHIN@lhsc.on.ca

North Central Cancer Treatment Group

John Bolton, MD, Protocol chair		Ph: 504-842-4070; 888-624-7637 Email: jbolton@ochsner.org

Radiation Therapy Oncology Group

Arthur Porter, MD, Protocol chair		Ph: 216-461-6430

Cancer and Leukemia Group B

Parvesh Kumar, MD, Protocol chair(Contact information may not be current)		Ph: 732-235-6793

Registry Information
Official Title		Phase III Randomized Evaluation of Adjuvant Radiotherapy vs No Adjuvant Therapy Following Radical Prostatectomy and Pelvic Lymphadenectomy in Surgical Stage C Adenocarcinoma of the Prostate
Trial Start Date		1988-08-15
Registered in ClinicalTrials.gov		NCT00394511
Date Submitted to PDQ		1988-08-15
Information Last Verified		2008-07-21
NCI Grant/Contract Number		CA21115, CA21661, CA25224, CA31946, CA32102