Clinical trial NCT01368055: Hypofractionated Proton Radiation Therapy for Low and Intermediate Risk Prostate Cancer
Official title: An Expanded Phase II Study of Hypofractionated Dose Intense Image Guided Proton Radiation Therapy for Low and Intermediate Risk Adenocarcinoma of the Prostate
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Proton Radiation, Prostate Cancer
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2011-06-07
Enrollment: 361
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to give a shorter course (5 ½-6 weeks) of proton radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of proton radiation, without decreasing the chance of killing prostate cancer cells.


Eligibility criteria: Inclusion Criteria:

* Prostate cancer.
* Gleason score 2-6 or 7.
* PSA ≤ 20 ng/ml.

Exclusion Criteria:

* Previous prostate cancer surgery or pelvic radiation.
* Prior/concurrent systemic chemotherapy for prostate cancer.
* Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum.
* History of hip replacement.
* Prior intrapelvic surgery.
* Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its uses during radiation.
* Receiving continuous and current anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), dabigatran etexilate mesylate (Pradaxa),enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).

Primary outcomes:
measure: Cumulative incidence of treatment-related grade 2 or higher rectal bleeding.
timeFrame: 2 years after completion of radiation therapy
Secondary outcomes:
measure: Analyzation of quality of life
timeFrame: After radiation: every 6 months for 3 years, then annually for 20 years
measure: Analysis of treatment-related morbidity
timeFrame: Cumulative incidence up to 20 years after completion of radiation therapy
measure: Analysis of disease control
timeFrame: Cumulative incidence up to 20 years after completion of radiation therapy
measure: Analysis of overall survival
timeFrame: Cumulative incidence up to 20 years after completion of radiation therapy
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Proton Therapy Institute
state: Florida
Study officials:
affiliation: University of Florida Proton Therapy Institute
name: Curtis Bryant, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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