Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer
Conditions
Prostate CancerDrugs
Androgen Suppression TherapySummary
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.
Locations
4 locations Found with status Recruiting
Status
- RECRUITING
Contact Person
- : Clinical Trials Office - All Mayo Clinic Locations
- 855-776-0015 (toll free)
Principal Investigator
- Carlos Vargas, MD
Status
- RECRUITING
Contact Person
- Don Smith, MS, CCRC
- 630-933-7820
- [email protected]
Principal Investigator
- Carlos Vargas, MD
Status
- RECRUITING
Contact Person
- Jenny Washington, BSRT(T), CMD
- 405-773-6700
- [email protected]
Principal Investigator
- Carlos Vargas, MD
Status
- RECRUITING
Contact Person
- Donna Sternberg, RN, BSN, OCN
- 757-251-6839
- [email protected]
Principal Investigator
- Carlos Vargas, MD
Eligibility Criteria
Inclusion Criteria:
* Histologically confirmed prostate adenocarcinoma (within 365 days of randomization) at intermediate risk for reoccurrence determined by at least one of the following: Gleason Score 7, PSA > = 10 and < = 20, T stage T2b - T2c
* Clinical stages T1-T2c N0 M0 as staged by the treating investigator. (AJCC Criteria 7th Ed.- appendix III).
* Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range of 2-7. > 6 cores are strongly recommended.
* PSA values < = 20 ng/ml within 90 days prior to randomization. Obtained prior to biopsy or at least 21 days after prostate biopsy.
* ECOG performance status 0-1 (appendix II) assessed within 90 days of randomization.
* Patients must sign IRB approved study specific informed consent.
* Patients must complete all required pre-entry tests listed in section 4.0 within the specified time frames.
* Patients must be able to start treatment within 56 days of randomization.
* Patients must be at least 18 years old.
* For brachytherapy, an IPSS ≤ 21, or ≤ 17 if patient is on medications to improve urination.
* For brachytherapy, prostate volume must be less than 55cc prior to AS.
Exclusion Criteria:
* Pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
* Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery.
* Previous pelvic radiation for prostate cancer.
* Previous androgen suppression therapy for prostate cancer.
* Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
* Prior systemic chemotherapy for prostate cancer.
* History of proximal urethral stricture requiring dilatation.
* Current and continuing anticoagulation with warfarin sodium (Coumadin), heparin, low- molecular weight heparin, Clopidogrel bisulfate (Plavix), or equivalent (unless it can be stopped to manage treatment related toxicity or to have a biopsy if needed).
* Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study).
* Evidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed).
* History of myocardial infarction within the last 6 months.
Study Plan
Radiation Alone
ACTIVE_COMPARATOR
Proton Radiation Total Dose=70 Gy(RBE) OR High Dose Radiation with IMRT Alone=81 Gy OR Intraoperative LDR Brachytherapy and IMRT=45 Gy
RADIATION:
RadiationDescription:
Consists of:nn1. 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))n2. High Dose Radiation with IMRT alone: 1.8 Gy five days a week in 45 treatments over 9-10 weeks (total dose: 81 Gy)n3. 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)
Radiation + Androgen Suppression
EXPERIMENTAL
Androgen Suppression Therapy x 6 months + Radiation
RADIATION:
RadiationDescription:
Consists of:nn1. 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))n2. High Dose Radiation with IMRT alone: 1.8 Gy five days a week in 45 treatments over 9-10 weeks (total dose: 81 Gy)n3. 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)DRUG:
Androgen Suppression TherapyDescription:
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)
Outcome Measures
Primary Outcome Measures
Morbidity Outcomes
Secondary Outcome Measures
Frequency and severity of grade 2 or higher GU and GI toxicity
Frequency and severity of GI and GU toxicity
Incidence of quality of life issues
Incidence of Freedom from biochemical failure (FFBF)
Incidence of clinical failure: local and/or distant
Incidence of salvage Androgen Suppression use (SAD)
Incidence of progression free survival: using clinical, biochemical and SAD as events
Incidence of overall survival
Incidence of disease-specific survival
Correlate pathologic and radiologic findings with outcomes
Correlate PSA and free PSA levels with outcomes
Correlate testosterone levels and variation with proton therapy and outcomes
Prospectively collect information that will help to define dose-volume relationships of normal structures with acute and chronic toxicity
Timeline
Last Updated
June 3, 2024Start Date
December 15, 2011Today
January 16, 2025Completion Date ( Estimated )
Not available
Sponsors of this trial
Lead Sponsor
Proton Collaborative Group