Clinical Trials /

Study of Hypo-fractionated Proton Radiation for Low Risk Prostate Cancer

NCT01230866

Description:

The purpose of this study is to compare the effects (good and bad) on patients with prostate cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks) with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of the treatments are similar or better.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study of Hypo-fractionated Proton Radiation for Low Risk Prostate Cancer
  • Official Title: A Phase III Prospective Randomized Trial of Standard-fractionation vs. Hypo-fractionation With Proton Radiation Therapy for Low Risk Adenocarcinoma of the Prostate

Clinical Trial IDs

  • ORG STUDY ID: GU002-10
  • NCT ID: NCT01230866

Conditions

  • Prostate Cancer

Purpose

The purpose of this study is to compare the effects (good and bad) on patients with prostate cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks) with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of the treatments are similar or better.

Trial Arms

NameTypeDescriptionInterventions
Proton Radiation HypofractionationOther5 fractions (7.6 Gy(RBE) x 5)
    Proton Radiation Standard FractionationActive Comparator44 fractions (1.8 Gy(RBE) x 44)

      Eligibility Criteria

              Inclusion Criteria:
      
                -  Histologically confirmed prostate adenocarcinoma within 365 days prior to
                   randomization.
      
                -  History/physical examination with digital rectal examination of the prostate and
                   baseline toxicity assessment within 90 days prior to randomization.
      
                -  Histological evaluation of prostate biopsy with assignment of a Gleason score to the
                   biopsy material;Gleason score must be in the range of 2-6. > 6 cores are strongly
                   recommended.
      
                -  PSA values < 10 ng/ml within 90 days prior to randomization. Either done prior to
                   biopsy or at least 21 days after prostate biopsy.
      
                -  Clinical stages T1a-T2a N0 M0 (AJCC Criteria 7th Ed.). Staging must be done by
                   treating investigator.
      
                -  No pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node
                   is biopsied and negative.
      
                -  Patients must be at least 18 years old.
      
                -  ECOG performance status 0-1 (appendix I) documented within 90 days prior to
                   randomization.
      
                -  IPSS score < 16.
      
                -  Patients must give IRB approved, study specific, informed consent.
      
                -  Patients must complete all mandatory tests listed in section 4.0 within the specified
                   time frames.
      
                -  Patients must be able to start treatment within 56 days of randomization.
      
              Exclusion Criteria:
      
                -  Previous prostate cancer surgery to include: prostatectomy, hyperthermia and
                   cryosurgery.
      
                -  Previous pelvic radiation for prostate cancer.
      
                -  Androgen deprivation therapy prior to radiation is allowed. However, it is not
                   acceptable if continued during radiation or as adjuvant therapy.
      
                -  Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative
                   colitis.
      
                -  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, to have a biopsy if needed,
                   or for marker placement).
      
                -  Any major medical, addictive or psychiatric illnesses which would affect the consent
                   process, completion of treatment and/or interfere with follow-up. Consent by legal
                   authorized representative is not permitted in 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).
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:Male
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:To assess if hypo-fractionation will result in 2-year freedom from failure (FFF) that is non-inferior to 2-year FFF following standard fractionation. FFF will be measured by recurrence, metastasis, PSA or start of salvage therapy.
      Time Frame:At 5 years post treatment completion +/- 90 days
      Safety Issue:
      Description: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),or the start of salvage therapy including androgen deprivation.

      Secondary Outcome Measures

      Measure:To determine the incidence of grade 2 or greater GU and GI toxicity in each of the regimens
      Time Frame:At 6 months and 2 years post randomization
      Safety Issue:
      Description:

      Details

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

      Trial Keywords

      • Proton Radiation Prostate Cancer

      Last Updated

      December 14, 2016