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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00394511
Recruitment Status : Completed
First Posted : November 1, 2006
Last Update Posted : February 11, 2013
Southwest Oncology Group
NCIC Clinical Trials Group
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: low-LET photon therapy Phase 3

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 1988
Actual Primary Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male


--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
Publications of Results:
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.

Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Cancer Institute (NCI) Identifier: NCT00394511    
Other Study ID Numbers: NCI-2012-02483
CDR0000075112 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: November 1, 2006    Key Record Dates
Last Update Posted: February 11, 2013
Last Verified: October 2006
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases