Clinical trial NCT00585962: Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate
Official title: A Phase II Study Using Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: proton beam radiation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: American College of Radiology Imaging Network
First posted: 2008-01-04
Enrollment: 57
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to determine if high doses of radiation using proton beam can be given safely with low and acceptable side effects. This study will also gather data to determine the ability of the proton beam to eradicate prostate cancer. Proton beam radiation is a very accurate kind of treatment that has been shown to affect less normal tissue than a regular radiation beam.

Detailed description: * Radiation therapy to the pelvis and prostate will be given once a day, 5 days a week (Monday-Friday), for 8 weeks. Each treatment takes about 10-20 minutes.
* Participants will be seen once a week for the entire 8 weeks by their study doctor to monitor and record any side effects. At the end of radiation therapy, participants will have a history and physical examination. Follow-up visits with the study doctor will be done at weeks 13 and 26 and then every 6 months for 3 years, then annually to year five.

Eligibility criteria: Inclusion Criteria:

* Patients with previously treated adenocarcinoma of the stages T1c-T2b and Gleason of equal to or greater than 5.
* PSA values of equal to or less than 15 ng/ml must be demonstrated within two months prior to study entry and greater than 3 weeks after prostate biopsy.
* Zubrod status 0-1.
* No evidence of distant metastasis.
* No evidence of other cancer. Prior malignancy does not exclude the patient if disease free for greater than five years.

Exclusion Criteria:

* Clinical stages T2c or above.
* PSA greater than 15.
* Any patient with T1c disease, a PSA less than or equal to 4 and Gleason sum less than 6.
* Evidence of lymph node involvement if lymph node sampling performed.
* Previous prostate surgery to include: simple prostatectomy, TURP, hyperthermia and cryosurgery.
* Previous prostate radiation.
* Prior hormonal therapy.
* History of inflammatory bowel disease even if currently inactive or controlled on medication.
* Prior systemic chemotherapy.
* History of proximal urethral stricture requiring dilatation.
* Current and continuing anticoagulation with Coumadin or equivalent.
* Major medical or psychiatric illness

Primary outcomes:
measure: To assess the late morbidity of 82 GY delivered to the prostate and surrounding tissues using proton beam radiation
timeFrame: 3 years
Secondary outcomes:
measure: To assess the acute morbidity following protocol treatment and to determine the ability of this treatment to control cancer.
timeFrame: 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Anthony Zietman, MD
role: PRINCIPAL_INVESTIGATOR
References: