Clinical Trials /

Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer

NCT01492972

Description:

The purpose of this study is to compare the effects, good and/or bad of two treatment methods on subjects and their cancer. Proton beam radiation therapy is one of the treatments for men with prostate cancer who have localized disease. The benefit of the combination with androgen suppression is not completely understood. This study will compare the use of hypofraction proton therapy (28 treatments) alone to proton therapy with androgen suppression therapy.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer
  • Official Title: Phase III Study of Image Guided Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Adenocarcinoma of the Prostate

Clinical Trial IDs

  • ORG STUDY ID: GU003-10
  • NCT ID: NCT01492972

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
Androgen Suppression Therapyleuprolide, goserelin, buserelin, or triptorelinRadiation + Androgen Suppression

Purpose

The purpose of this study is to compare the effects, good and/or bad of two treatment methods on subjects and their cancer. Proton beam radiation therapy is one of the treatments for men with prostate cancer who have localized disease. The benefit of the combination with androgen suppression is not completely understood. This study will compare the use of hypofraction proton therapy (28 treatments) alone to proton therapy with androgen suppression therapy.

Trial Arms

NameTypeDescriptionInterventions
Radiation AloneActive ComparatorProton Radiation Total Dose=70 Gy(RBE) OR High Dose Radiation with IMRT Alone=81 Gy OR Intraoperative LDR Brachytherapy and IMRT=45 Gy
    Radiation + Androgen SuppressionExperimentalAndrogen Suppression Therapy x 6 months + Radiation
    • Androgen Suppression Therapy

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Histologically confirmed prostate adenocarcinoma (within 365 days of randomization)
                 at intermediate risk for reoccurrence determined by at least one of the following:
                 Gleason Score 7, PSA > = 10 and < = 20, T stage T2b - T2c
    
              -  Clinical stages T1-T2c N0 M0 as staged by the treating investigator. (AJCC Criteria
                 7th Ed.- appendix III).
    
              -  Histological evaluation of prostate biopsy with assignment of a Gleason score to the
                 biopsy material; Gleason score must be in the range of 2-7. > 6 cores are strongly
                 recommended.
    
              -  PSA values < = 20 ng/ml within 90 days prior to randomization. Obtained prior to
                 biopsy or at least 21 days after prostate biopsy.
    
              -  ECOG performance status 0-1 (appendix II) assessed within 90 days of randomization.
    
              -  Patients must sign IRB approved study specific informed consent.
    
              -  Patients must complete all required pre-entry tests listed in section 4.0 within the
                 specified time frames.
    
              -  Patients must be able to start treatment within 56 days of randomization.
    
              -  Patients must be at least 18 years old.
    
              -  For brachytherapy, an IPSS ≤ 21, or ≤ 17 if patient is on medications to improve
                 urination.
    
              -  For brachytherapy, prostate volume must be less than 55cc prior to AS.
    
            Exclusion Criteria:
    
              -  Pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node is
                 biopsied and negative.
    
              -  Previous prostate cancer surgery to include: prostatectomy, hyperthermia and
                 cryosurgery.
    
              -  Previous pelvic radiation for prostate cancer.
    
              -  Previous androgen suppression therapy for prostate cancer.
    
              -  Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative
                 colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are
                 allowed).
    
              -  Prior systemic chemotherapy for prostate cancer.
    
              -  History of proximal urethral stricture requiring dilatation.
    
              -  Current and continuing anticoagulation with warfarin sodium (Coumadin), heparin, low-
                 molecular weight heparin, Clopidogrel bisulfate (Plavix), or equivalent (unless it
                 can be stopped to manage treatment related toxicity or to have a biopsy if needed).
    
              -  Major medical, addictive or psychiatric illness which in the investigator's opinion,
                 will prevent the consent process, completion of the treatment and/or interfere with
                 follow-up. (Consent by legal authorized representative is not permitted for this
                 study).
    
              -  Evidence of any other cancer within the past 5 years and < 50% probability of a 5
                 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous
                 cell cancer of the skin is allowed).
    
              -  History of myocardial infarction within the last 6 months.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Morbidity Outcomes
    Time Frame:after the initial 100 patients have had a median follow up of at least three years and then every year.
    Safety Issue:
    Description:To determine if androgen suppression along with radiation therapy will result in a higher freedom from failure (FFF) than radiation therapy without androgen suppression. Freedom from failure (FFF): The events for FFF will be the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA ≥ 2 ng/ml over the current nadir PSA) (45) discounting bounces per investigator discretion, or the start of salvage therapy including androgen suppression

    Secondary Outcome Measures

    Measure:Frequency and severity of grade 2 or higher GU and GI toxicity
    Time Frame:At 6 months
    Safety Issue:
    Description:Assessment of grade 2 or higher GU and GI toxicity using CTCAE 4.0 criteria
    Measure:Frequency and severity of GI and GU toxicity
    Time Frame:At 3 years
    Safety Issue:
    Description:
    Measure:Incidence of quality of life issues
    Time Frame:At completion of radiation therapy
    Safety Issue:
    Description:
    Measure:Incidence of Freedom from biochemical failure (FFBF)
    Time Frame:At 5 years
    Safety Issue:
    Description:
    Measure:Incidence of clinical failure: local and/or distant
    Time Frame:At 5 years
    Safety Issue:
    Description:
    Measure:Incidence of salvage Androgen Suppression use (SAD)
    Time Frame:At 5 years
    Safety Issue:
    Description:
    Measure:Incidence of progression free survival: using clinical, biochemical and SAD as events
    Time Frame:At 5 years
    Safety Issue:
    Description:
    Measure:Incidence of overall survival
    Time Frame:At 5 years
    Safety Issue:
    Description:
    Measure:Incidence of disease-specific survival
    Time Frame:At 5 years
    Safety Issue:
    Description:
    Measure:Correlate pathologic and radiologic findings with outcomes
    Time Frame:At 5 years
    Safety Issue:
    Description:
    Measure:Correlate PSA and free PSA levels with outcomes
    Time Frame:At 5 years
    Safety Issue:
    Description:
    Measure:Correlate testosterone levels and variation with proton therapy and outcomes
    Time Frame:At 5 years
    Safety Issue:
    Description:
    Measure:Prospectively collect information that will help to define dose-volume relationships of normal structures with acute and chronic toxicity
    Time Frame:At 3 years
    Safety Issue:
    Description:

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Proton Collaborative Group

    Trial Keywords

    • Prostate
    • proton
    • radiation
    • intermediate risk

    Last Updated

    December 14, 2016