Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01230866
Previous Study | Return to List | Next Study

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

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.
 
ClinicalTrials.gov Identifier: NCT01230866
Recruitment Status : Recruiting
First Posted : October 29, 2010
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Proton Collaborative Group

Tracking Information
First Submitted Date  ICMJE October 27, 2010
First Posted Date  ICMJE October 29, 2010
Last Update Posted Date July 12, 2019
Study Start Date  ICMJE November 2010
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2010)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2018)
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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Hypo-fractionated Proton Radiation for Low Risk Prostate Cancer
Official Title  ICMJE A Phase III Prospective Randomized Trial of Standard-fractionation vs. Hypo-fractionation With Proton Radiation Therapy for Low Risk Adenocarcinoma of the Prostate
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 6, 2016)
150
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2010)
448
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tish Adams, MS, CCRC, CP 913-788-6429 tadams@pcgresearch.org
Contact: Matthew Morocco, BS 630-836-8670 mmorocco@pcgresearch.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01230866
Other Study ID Numbers  ICMJE GU002-10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Proton Collaborative Group
Study Sponsor  ICMJE Proton Collaborative Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Carlos Vargas, MD Proton Collaborative Group
PRS Account Proton Collaborative Group
Verification Date July 2019

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