NCT01492972 Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer
| NCT ID | NCT01492972 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Proton Collaborative Group |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 192 participants |
| Start Date | 2012-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 192 participants in total. It began in 2012-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Carlos Vargas, MD
PRINCIPAL INVESTIGATOR
Proton Collaborative Group
Frequently Asked Questions
Who can join the NCT01492972 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT01492972 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 192 participants.
Is NCT01492972 currently recruiting?
Yes, NCT01492972 is actively recruiting participants. Visit ClinicalTrials.gov or contact Proton Collaborative Group to inquire about joining.
Where is the NCT01492972 trial being conducted?
This trial is being conducted at Scottsdale, United States, Warrenville, United States, Oklahoma City, United States, Hampton, United States.
Who is sponsoring the NCT01492972 clinical trial?
NCT01492972 is sponsored by Proton Collaborative Group. The principal investigator is Carlos Vargas, MD at Proton Collaborative Group. The trial plans to enroll 192 participants.
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