Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy
NCT ID: NCT00969111
Last Updated: 2025-09-09
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
70 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-08-31
Study Completion Date
2050-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Prostate Cancer
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Postop Non-High Risk
Proton to 66.6 CGE
Group Type
EXPERIMENTAL
Proton to 66.6 CGE
Intervention Type
RADIATION
Post-Op Non High Risk
Postop High Risk
IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
Group Type
EXPERIMENTAL
IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
Intervention Type
RADIATION
Postop High Risk
Salvage Non-High Risk
Proton to 70.2 CGE
Group Type
EXPERIMENTAL
Proton (prostate bed) to 70.2 CGE
Intervention Type
RADIATION
Salvage Non-High Risk
Salvage High Risk
IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
Group Type
EXPERIMENTAL
IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
Intervention Type
RADIATION
Salvage High Risk
Interventions
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IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
Postop High Risk
Intervention Type
RADIATION
Proton (prostate bed) to 70.2 CGE
Salvage Non-High Risk
Intervention Type
RADIATION
IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
Salvage High Risk
Intervention Type
RADIATION
Proton to 66.6 CGE
Post-Op Non High Risk
Intervention Type
RADIATION
Eligibility Criteria
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Inclusion Criteria
* Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
* Maximum PSA value of 20 ng/ml.
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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University of Florida Health
OTHER
Sponsor Role
collaborator
Proton Collaborative Group
NETWORK
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Randal H Henderson, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida Proton Therapy Institute
Locations
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Proton Center of Arkansas
Little Rock, Arkansas, United States
Site Status
RECRUITING
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States
Site Status
RECRUITING
Northwestern Medicine Chicago Proton Center
Warrenville, Illinois, United States
Site Status
RECRUITING
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Site Status
RECRUITING
Countries
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United States
Facility Contacts
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Intake Coordinator
Role: primary
877-686-6009
References
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Other Identifiers
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UFPTI 0902-PR06
Identifier Type: OTHER
Identifier Source: secondary_id
GU010-18
Identifier Type: -
Identifier Source: org_study_id
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