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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Proton Collaborative Group
Study ID
NCT00969111
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE — RADIATION
    Postop High Risk
  • Proton (prostate bed) to 70.2 CGE — RADIATION
    Salvage Non-High Risk
  • IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE — RADIATION
    Salvage High Risk
  • Proton to 66.6 CGE — RADIATION
    Post-Op Non High Risk

Study Details

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.

Key Dates

Start date
Aug 31, 2009
Status verified
Sep 2025
Primary completion
Aug 31, 2031
Completion
Aug 31, 2050

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Postop Non-High Risk
    Proton to 66.6 CGE
  • Experimental: Postop High Risk
    IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
  • Experimental: Salvage Non-High Risk
    Proton to 70.2 CGE
  • Experimental: Salvage High Risk
    IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE

Primary Outcome Measure

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 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Proton Center of ArkansasLittle RockArkansas72205
Monica Coleman
[email protected]
501-686-8274
Sanjay Maraboyina, MD (PRINCIPAL_INVESTIGATOR)
University of Florida Proton Therapy InstituteJacksonvilleFlorida32206
Intake Coordinator
877-686-6009
Randal H Henderson, MD (PRINCIPAL_INVESTIGATOR)
Northwestern Medicine Chicago Proton CenterWarrenvilleIllinois60555
Don Smith, MS, CCRC
[email protected]
630-933-7820
Arpi Thukral, MD (PRINCIPAL_INVESTIGATOR)
Inova Schar Cancer InstituteFairfaxVirginia22031
Sangeetha Moturi
[email protected]
571-472-0343
Kevin Choe, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Little Rock, AR

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Proton Center of Arkansas· Little Rock, ARUniversity of Florida Proton Therapy Institute· Jacksonville, FLNorthwestern Medicine Chicago Proton Center· Warrenville, ILInova Schar Cancer Institute· Fairfax, VA

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