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Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
radiation therapy
Sponsored by
Barbara Ann Karmanos Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Stage I-III disease (T1-T3, N0, M0) No clinical or radiographic evidence of metastasis If prostate-specific antigen (PSA) ≥ 10.0 ng/mL and Gleason score is 7, a radioisotope bone scan must show no evidence of metastasis No evidence of lymphatic or visceral metastases of the abdomen or pelvis on CT scan or MRI PSA ≤ 20 ng/mL Gleason score ≤ 7 (if stage T3 , score must be < 7) PATIENT CHARACTERISTICS: Performance status Not specified Life expectancy More than 10 years Hematopoietic Not specified Hepatic Not specified Renal Not specified Other No other malignancy within the past 5 years except basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Endocrine therapy Prior hormonal therapy allowed provided it was initiated no more than 2 months ago, and may include the following: Luteinizing hormone-releasing hormone agonists (e.g., goserelin, leuprolide) Anti-androgens (e.g., flutamide, bicalutamide) Radiotherapy No prior pelvic irradiation Surgery No prior radical prostatectomy

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Occurrence of chronic grade 2 or higher toxicity as measured by RTOG/EORTC late morbidity scoring scheme at 1, 4, 8, and 12 months after treatment, then every 6 months for 5 years, then annually

    Secondary Outcome Measures

    Disease free survival at 1, 4, 8, and 12 months after treatment, then every 6 months for 5 years, then annually

    Full Information

    First Posted
    November 23, 2005
    Last Updated
    April 5, 2013
    Sponsor
    Barbara Ann Karmanos Cancer Institute
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00258466
    Brief Title
    Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer
    Official Title
    Phase III Trial of Neutron + Photon Radiation Versus Photon + Hypofractionated Intensity Modulated Radiation Therapy in Localized Prostate Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2013
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    May 2005 (undefined)
    Primary Completion Date
    November 2006 (Actual)
    Study Completion Date
    November 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Barbara Ann Karmanos Cancer Institute
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. It is not yet known which type of radiation therapy is more effective in treating prostate cancer. PURPOSE: This randomized phase III trial is studying different types of radiation therapy to compare how well they work in treating patients with stage I, stage II, or stage III prostate cancer.
    Detailed Description
    OBJECTIVES: Compare the efficacy of neutron and photon radiotherapy vs hypofractionated intensity modulated radiation, in terms of a lower frequency of chronic complication rate (chronic toxicity and disease-free survival), in patients with favorable to intermediate prognosis, stage I-III adenocarcinoma of the prostate. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage of disease (T1 vs T2 vs T3). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo neutron radiotherapy over 15-45 minutes 5 days a week for 2 weeks followed by photon radiotherapy over 15-45 minutes 5 days a week for 5 weeks. Arm II: Patients undergo photon radiotherapy over 15-45 minutes 5 days a week for 5 weeks followed by hypofractionated photon irradiation over 15-45 minutes 5 days a week for 2 weeks. After completion of study treatment, patients are followed periodically for 5 years and then yearly thereafter. PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Radiation
    Intervention Name(s)
    radiation therapy
    Primary Outcome Measure Information:
    Title
    Occurrence of chronic grade 2 or higher toxicity as measured by RTOG/EORTC late morbidity scoring scheme at 1, 4, 8, and 12 months after treatment, then every 6 months for 5 years, then annually
    Secondary Outcome Measure Information:
    Title
    Disease free survival at 1, 4, 8, and 12 months after treatment, then every 6 months for 5 years, then annually

    10. Eligibility

    Sex
    Male
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Stage I-III disease (T1-T3, N0, M0) No clinical or radiographic evidence of metastasis If prostate-specific antigen (PSA) ≥ 10.0 ng/mL and Gleason score is 7, a radioisotope bone scan must show no evidence of metastasis No evidence of lymphatic or visceral metastases of the abdomen or pelvis on CT scan or MRI PSA ≤ 20 ng/mL Gleason score ≤ 7 (if stage T3 , score must be < 7) PATIENT CHARACTERISTICS: Performance status Not specified Life expectancy More than 10 years Hematopoietic Not specified Hepatic Not specified Renal Not specified Other No other malignancy within the past 5 years except basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Endocrine therapy Prior hormonal therapy allowed provided it was initiated no more than 2 months ago, and may include the following: Luteinizing hormone-releasing hormone agonists (e.g., goserelin, leuprolide) Anti-androgens (e.g., flutamide, bicalutamide) Radiotherapy No prior pelvic irradiation Surgery No prior radical prostatectomy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jeffrey D. Forman, MD, FACR
    Organizational Affiliation
    Weisberg Cancer Treatment Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer

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