Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Proton Collaborative Group
Study ID
NCT01492972
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Radiation — RADIATION
    Consists of: 1. Conformal Proton Radiation Dose: 2.5 Gy (RBE) five days a week in 28 treatments over 5.5-6.5 weeks (total dose: 70 Gy (RBE)) 2. High Dose Radiation with IMRT alone: 1.8 Gy five days a week in 45 treatments over 9-10 weeks (total dose: 81 Gy) 3. Intraoperative LDR Brachytherapy and IMRT: 100Gy Pad103 implant and IMRT 1.8 Gy five days a week in 25 treatments over 5-6 weeks (total dose: 45 Gy)
  • Androgen Suppression Therapy — DRUG
    Androgen suppression will begin 8 - 10 weeks prior to the start of RT for a total of 6 (+/- 2) months. Luteinizing Hormone-Releasing Hormone (LHRH) agonist therapy will consist of analogs approved by the FDA (or by Health Canada for Canadian institutions)

Study Details

The purpose of this study is to compare the effects, good and/or bad of two treatment methods on subjects and their cancer. Proton beam radiation therapy is one of the treatments for men with prostate cancer who have localized disease. The benefit of the combination with androgen suppression is not completely understood. This study will compare the use of hypofraction proton therapy (28 treatments) alone to proton therapy with androgen suppression therapy.

Key Dates

Start date
Jan 31, 2012
Status verified
Sep 2025
Primary completion
Dec 31, 2027

Study Design

Enrollment
192 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Radiation Alone
    Proton Radiation Total Dose=70 Gy(RBE) OR High Dose Radiation with IMRT Alone=81 Gy OR Intraoperative LDR Brachytherapy and IMRT=45 Gy
  • Experimental: Radiation + Androgen Suppression
    Androgen Suppression Therapy x 6 months + Radiation

Primary Outcome Measure

Morbidity Outcomes [ Time Frame: after the initial 100 patients have had a median follow up of at least three years and then every year. ]

Locations (4)

FacilityCityStateZIPSite coordinators
Mayo ClinicScottsdaleArizona85259-5499
: Clinical Trials Office - All Mayo Clinic Locations
855-776-0015 (toll free)
Northwestern Medicine Chicago Proton CenterWarrenvilleIllinois60555
Don Smith, MS, CCRC
[email protected]
630-933-7820
Arpi Thukral, MD (PRINCIPAL_INVESTIGATOR)
Oklahoma Proton CenterOklahoma CityOklahoma73142
Angela Beebe
[email protected]
405-773-6708
John Chang, MD (PRINCIPAL_INVESTIGATOR)
Hampton University Proton Therapy InstituteHamptonVirginia23666
Donna Sternberg, RN, BSN, OCN
[email protected]
757-251-6839
Christopher Sinesi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Mayo Clinic· Scottsdale, AZNorthwestern Medicine Chicago Proton Center· Warrenville, ILOklahoma Proton Center· Oklahoma City, OKHampton University Proton Therapy Institute· Hampton, VA

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