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

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

Randomized phase III trial to compare treatment with or without adjuvant radiation therapy in men with stage III prostate cancer who have had radical prostatectomy and lymphadenectomy recently. Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for prostate cancer.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: low-LET photon therapy

Detailed Description

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.

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.

• Study Type: Interventional
• Enrollment (Actual): 408
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

Description

PROTOCOL 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

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

--Prior Concurrent Therapy--

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I; Radiotherapy. Irradiation of the prostatic bed using megavoltage equipment with effective photon energies of greater than 4 MV.	Procedure: low-LET photon therapy
No Intervention: Arm II; No further treatment.

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Collaborators: Eastern Cooperative Oncology Group; NCIC Clinical Trials Group; Southwest Oncology Group; Cancer and Leukemia Group B; Radiation Therapy Oncology Group; North Central Cancer Treatment Group

Publications and helpful links

General Publications

• Thompson IM, Paradelo JC, Crawford ED, Coltman CA, Blumenstein B. An opportunity to determine optimal treatment of pT3 prostate cancer: the window may be closing. Urology. 1994 Dec;44(6):804-11. doi: 10.1016/s0090-4295(94)80161-4. No abstract available.
• 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.
• Thompson IM Jr, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, Messing E, Forman J, Chin J, Swanson G, Canby-Hagino E, Crawford ED. Adjuvant radiotherapy for pathologically advanced prostate cancer: a randomized clinical trial. JAMA. 2006 Nov 15;296(19):2329-35. doi: 10.1001/jama.296.19.2329.

Study record dates

Study Major Dates

• Study Start: August 1, 1988
• Primary Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: October 31, 2006
• First Submitted That Met QC Criteria: October 31, 2006
• First Posted (Estimate): November 1, 2006

Study Record Updates

• Last Update Posted (Estimate): February 11, 2013
• Last Update Submitted That Met QC Criteria: February 8, 2013
• Last Verified: October 1, 2006

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: NCI-2012-02483; SWOG-8794; CAN-NCIC-PR2; CLB-9493; EST-9887; NCCTG-895251; RTOG-9019; INT-0086; CDR0000075112 (Registry Identifier: PDQ (Physician Data Query))