search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
low-LET photon therapy
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)Male

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Arm I

    Arm II

    Arm Description

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

    No further treatment.

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 31, 2006
    Last Updated
    February 8, 2013
    Sponsor
    National Cancer Institute (NCI)
    Collaborators
    SWOG Cancer Research Network, NCIC Clinical Trials Group, Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, North Central Cancer Treatment Group, Radiation Therapy Oncology Group
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00394511
    Brief Title
    Radiation Therapy After Prostatectomy in Treating Patients With Stage III Prostate Cancer
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1988 (undefined)
    Primary Completion Date
    December 2006 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Cancer Institute (NCI)
    Collaborators
    SWOG Cancer Research Network, NCIC Clinical Trials Group, Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, North Central Cancer Treatment Group, Radiation Therapy Oncology Group

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    408 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm I
    Arm Type
    Experimental
    Arm Description
    Radiotherapy. Irradiation of the prostatic bed using megavoltage equipment with effective photon energies of greater than 4 MV.
    Arm Title
    Arm II
    Arm Type
    No Intervention
    Arm Description
    No further treatment.
    Intervention Type
    Procedure
    Intervention Name(s)
    low-LET photon therapy

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Eligibility 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    7985307
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    17105795
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs