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Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy

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ClinicalTrials.gov Identifier: NCT00969111
Recruitment Status : Recruiting
First Posted : August 31, 2009
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
University of Florida Health
Information provided by (Responsible Party):
Proton Collaborative Group

Tracking Information
First Submitted Date  ICMJE August 28, 2009
First Posted Date  ICMJE August 31, 2009
Last Update Posted Date July 12, 2019
Study Start Date  ICMJE August 2009
Estimated Primary Completion Date August 2031   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2013)
The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy. [ Time Frame: 6 months after the end of radiation therapy ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 28, 2009)
Collect and analyze morbidity outcomes [ Time Frame: Every 3 months for 2 years then every 6 months for 1 year then annually ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2013)
Collect and analyze quality of life, treatment-related morbidity, disease control and survival outcome parameters [ Time Frame: After radiation: every 6 months for 3 years, then annually for 20 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2009)
Collect and analyze quality of life, disease control and survival outcome parameters [ Time Frame: after RT, every 6 months for 3 years, then annually ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy
Official Title  ICMJE Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy
Brief Summary The purpose of this study is to see what effects, good and/or bad, proton radiation, and/or conventional radiation and hormonal therapy (if applicable), has on prostate cancer that has already returned or the risk of prostate cancer returning.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Radiation: IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
    Postop High Risk
  • Radiation: Proton (prostate bed) to 70.2 CGE
    Salvage Non-High Risk
  • Radiation: IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
    Salvage High Risk
  • Radiation: Proton to 66.6 CGE
    Post-Op Non High Risk
Study Arms  ICMJE
  • Experimental: Postop Non-High Risk
    Proton to 66.6 CGE
    Intervention: Radiation: Proton to 66.6 CGE
  • Experimental: Postop High Risk
    IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
    Intervention: Radiation: IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
  • Experimental: Salvage Non-High Risk
    Proton to 70.2 CGE
    Intervention: Radiation: Proton (prostate bed) to 70.2 CGE
  • Experimental: Salvage High Risk
    IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
    Intervention: Radiation: IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
Publications *

*   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: September 14, 2012)
70
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2009)
182
Estimated Study Completion Date  ICMJE August 2050
Estimated Primary Completion Date August 2031   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
  • Maximum PSA value of 20 ng/ml.

Exclusion Criteria:

  • Evidence of distant metastasis (M1).
  • Prior systemic chemotherapy for any reason.
  • Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment.
  • Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
  • History of hip replacement.
  • Prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years.
  • Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
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 NCT00969111
Other Study ID Numbers  ICMJE GU010-18
UFPTI 0902-PR06 ( Other Identifier: University of Florida Health Proton Therapy Institute )
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 University of Florida Health
Investigators  ICMJE
Principal Investigator: Randal H Henderson, MD University of Florida Proton Therapy Institute
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