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

This study has been completed.
Sponsor:
Collaborators:
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)
ClinicalTrials.gov Identifier:
NCT00394511
First received: October 31, 2006
Last updated: February 8, 2013
Last verified: October 2006
History of Changes
  Purpose

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 Intervention Phase
Prostate Cancer
 Procedure: 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: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Enrollment: 408
Study Start Date: August 1988
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00394511     History of Changes
Other Study ID Numbers: NCI-2012-02483, SWOG-8794, CAN-NCIC-PR2, CLB-9493, EST-9887, NCCTG-895251, RTOG-9019, INT-0086, CDR0000075112
Study First Received: October 31, 2006
Last Updated: February 8, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013