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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Proton Collaborative Group
Sponsor:
Information provided by (Responsible Party):
Proton Collaborative Group
ClinicalTrials.gov Identifier:
NCT01230866
First received: October 27, 2010
Last updated: December 14, 2016
Last verified: December 2016

October 27, 2010
December 14, 2016
November 2010
December 2018   (Final data collection date for primary outcome 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 ]
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.
To determine if hypo-fractionation will result in freedom from failure (FFF) that is equivalent to FFF following standard fractionation. FFF will be measured by recurrence, metastasis, PSA or start of salvage therapy.
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.
Complete list of historical versions of study NCT01230866 on ClinicalTrials.gov Archive Site
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 ]
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Study of Hypo-fractionated Proton Radiation for Low Risk Prostate Cancer
A Phase III Prospective Randomized Trial of Standard-fractionation vs. Hypo-fractionation With Proton Radiation Therapy for Low Risk Adenocarcinoma of the Prostate
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Radiation: Proton Radiation Hypofractionation
    Dose: 38 Gy(RBE); 7.6 GY(RBE) five days a week in 5 treatments over 1-2 weeks
    Other Name: Particle Therapy
  • Radiation: Proton Radiation Standard Fractionation
    Dose: 79.2 GY(RBE); 1.8 GY(RBE) five days a week in 44 treatments over 8.5-9 weeks
    Other Name: Particle Therapy
  • Proton Radiation Hypofractionation
    5 fractions (7.6 Gy(RBE) x 5)
    Intervention: Radiation: Proton Radiation Hypofractionation
  • Active Comparator: Proton Radiation Standard Fractionation
    44 fractions (1.8 Gy(RBE) x 44)
    Intervention: Radiation: Proton Radiation Standard Fractionation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
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December 2018   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact: Corey Woods, RN, MS, CCRC 630-836-8668 cwoods@pcgresearch.org
United States
 
 
NCT01230866
GU002-10
Yes
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Proton Collaborative Group
Proton Collaborative Group
Not Provided
Study Chair: Carlos Vargas, MD Proton Collaborative Group
Proton Collaborative Group
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP