NCT01950351Active, not recruitingPhase 2
Hypofractionated Proton Beam Therapy for Localized Prostate Cancer
Phase II Trial of Hypofractionated Proton Beam Therapy in Men With Localized Prostate Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 16 Jun 2026
Brief summary (registry, in English)
This phase II trial studies the side effects and how well hypofractionated proton beam radiation therapy works in treating patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 241 (actual)
- First submitted
- 23 Sept 2013
- Start date
- 10 Oct 2013
- Primary completion date
- 1 Jun 2028
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Prostate cancer
- NCT number
- NCT01950351
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 241
- From 10 Oct 2013 to the primary completion date, 1 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or concurrent invasive malignancy (except non-melanomatous skin cancer or lymphomatous/hematogenous malignancy) unless continually disease free for a minimum of 5 years
- Previous prostatectomy, cryosurgery, or high intensity focused ultrasound (HIFU) for prostate cancer
- Previous pelvic radiation or prostate brachytherapy
Other illness
- Active and severe medical co-morbidity defined as follows: unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months, transmural myocardial infarction within the last 6 months, acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration, hepatic insufficiency resulting in clinical jaundice, active inflammatory bowel disease (Crohn's disease or ulcerative colitis), diagnosed connective tissue disorder, or congenital coagulation defects (patients on medical therapy with Coumadin or other blood thinning agents are eligible for participation)
Other
- Evidence of distant metastases
- Regional lymph node involvement
Who the study is looking for
- Histologically confirmed diagnosis of adenocarcinoma of the prostate within one year of study entry; evaluation can happen outside of MD Anderson as long as histological confirmation takes place at MD Anderson
- History/physical examination with digital rectal examination of the prostate within 90 days prior to registration
- Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material demonstrating Gleason score 2-7 within 365 days of registration
- Clinical stage T1-2b (American Joint Committee on Cancer \[AJCC\] 7th edition) and PSA \< 20 ng/mL within 90 days prior to registration; PSA should not be obtained within 10 days after prostate biopsy
- Zubrod performance status 0-1 within 90 days prior to registration
- Patient must be able to provide study-specific informed consent prior to study entry
- Willingness and ability to complete the EPIC questionnaire
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.