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

This study is currently recruiting participants.
Verified June 2017 by Proton Collaborative Group
Sponsor:
ClinicalTrials.gov Identifier:
NCT01230866
First Posted: October 29, 2010
Last Update Posted: June 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Proton Collaborative Group
  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.

Condition Intervention Phase
Prostate Cancer Radiation: Proton Radiation Hypofractionation Radiation: Proton Radiation Standard Fractionation Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Proton Collaborative Group:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: November 2010
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Proton Radiation Hypofractionation
5 fractions (7.6 Gy(RBE) x 5)
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
Active Comparator: Proton Radiation Standard Fractionation
44 fractions (1.8 Gy(RBE) x 44)
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230866


Contacts
Contact: Corey Woods, RN, MS, CCRC 630-836-8668 cwoods@pcgresearch.org

Locations
United States, Arizona
Mayo Clinic Cancer Center Recruiting
Phoenix, Arizona, United States, 85054
Contact: Clinical Trials Office - All Mayo Clinic Locations    855-776-0015 (toll free)      
United States, Illinois
Northwestern Medicine Chicago Proton Center Recruiting
Warrenville, Illinois, United States, 60555
Contact: Megan Boroczk    630-315-1797    Megan.Boroczk@nm.org   
Principal Investigator: William Hartsell, MD         
United States, Maryland
Maryland Proton Treatment Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Carl Brown    410-369-5353    CarlBrown@umm.edu   
Principal Investigator: Shahed Badiyan, MD         
United States, Oklahoma
ProCure Proton Therapy Center Recruiting
Oklahoma City, Oklahoma, United States, 73142
Contact: Kayla Tarrant    405-773-6775    research@okc.procure.com   
Principal Investigator: Gary Larson, MD         
United States, Virginia
Hampton University Proton Therapy Institute Recruiting
Hampton, Virginia, United States, 23666
Contact: Karl Citerella    757-251-6800    karl.citerella@hamptonproton.org   
Principal Investigator: Christopher Sinesi, MD         
Sponsors and Collaborators
Proton Collaborative Group
Investigators
Study Chair: Carlos Vargas, MD Proton Collaborative Group
  More Information

Responsible Party: Proton Collaborative Group
ClinicalTrials.gov Identifier: NCT01230866     History of Changes
Other Study ID Numbers: GU002-10
First Submitted: October 27, 2010
First Posted: October 29, 2010
Last Update Posted: June 21, 2017
Last Verified: June 2017

Keywords provided by Proton Collaborative Group:
Proton Radiation Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases