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Trial record 4 of 8 for:    GU010

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

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

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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

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




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 ]


Information from the National Library of Medicine

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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.

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
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Contact: Tish Adams, MS, CCRC, CP 913-788-6429 tadams@pcgresearch.org
Contact: Matthew Morocco, BS 630-836-8670 mmorocco@pcgresearch.org

Locations
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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         
Sponsors and Collaborators
Proton Collaborative Group
University of Florida Health
Investigators
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Principal Investigator: Randal H Henderson, MD University of Florida Proton Therapy Institute

Additional Information:
Publications:
American Cancer Society. 2007. Ref Type: Electronic Citation

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Responsible Party: Proton Collaborative Group
ClinicalTrials.gov Identifier: NCT00969111     History of Changes
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: July 12, 2019
Last Verified: July 2019

Keywords provided by Proton Collaborative Group:
Proton Radiation, Prostate Cancer

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