We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00969111
Previous Study | Return to List | Next Study

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

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: NCT00969111
Recruitment Status : Recruiting
First Posted : August 31, 2009
Last Update Posted : November 1, 2021
Sponsor:
Collaborator:
University of Florida Health
Information provided by (Responsible Party):
Proton Collaborative Group

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE Radiation: Proton (prostate bed) to 70.2 CGE Radiation: IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE Radiation: Proton to 66.6 CGE Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy
Study Start Date : August 2009
Estimated Primary Completion Date : August 2031
Estimated Study Completion Date : August 2050

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Postop Non-High Risk
Proton to 66.6 CGE
 Radiation: Proton to 66.6 CGE
Post-Op Non High Risk
Experimental: Postop High Risk
IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
 Radiation: IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
Postop High Risk
Experimental: Salvage Non-High Risk
Proton to 70.2 CGE
 Radiation: Proton (prostate bed) to 70.2 CGE
Salvage Non-High Risk
Experimental: Salvage High Risk
IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
 Radiation: IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
Salvage High Risk


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00969111


Contacts
Layout table for location contacts
Contact: Matthew Morocco 630-836-8670 mmorocco@pcgresearch.org

Locations
Layout table for location information
United States, Florida
University of Florida Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Intake Coordinator    877-686-6009      
Principal Investigator: Randal H Henderson, MD         
United States, Illinois
Northwestern Medicine Chicago Proton Center Recruiting
Warrenville, Illinois, United States, 60555
Contact: Don Smith, MS, CCRC    630-933-7820    donald.smith3@nm.org   
Principal Investigator: William Hartsell, MD         
United States, Virginia
Inova Schar Cancer Institute Recruiting
Fairfax, Virginia, United States, 22031
Contact: Sangeetha Moturi    571-472-0343    sangeetha.moturi@inova.org   
Principal Investigator: Kevin Choe, MD         
Sponsors and Collaborators
Proton Collaborative Group
University of Florida Health
Investigators
Layout table for investigator information
Principal Investigator: Randal H Henderson, MD University of Florida Proton Therapy Institute
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
American Cancer Society. 2007. Ref Type: Electronic Citation

Layout table for additonal information
Responsible Party: Proton Collaborative Group
ClinicalTrials.gov Identifier: NCT00969111    
Other Study ID Numbers: GU010-18
UFPTI 0902-PR06 ( Other Identifier: University of Florida Health Proton Therapy Institute )
First Posted: August 31, 2009    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: October 2021
Keywords provided by Proton Collaborative Group:
Proton Radiation, Prostate Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases