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A Phase II Study Using Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

A Phase II Study Using Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate

- 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.

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

- Evidence of lymph node involvement if lymph node sampling performed.

- Previous prostate surgery to include: simple prostatectomy, TURP, hyperthermia and

- Previous prostate radiation.

- Prior hormonal therapy.

- History of inflammatory bowel disease even if currently inactive or controlled on

- Prior systemic chemotherapy.

- History of proximal urethral stricture requiring dilatation.

- Current and continuing anticoagulation with Coumadin or equivalent.

- Major medical or psychiatric illness

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the late morbidity of 82 GY delivered to the prostate and surrounding tissues using proton beam radiation

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Anthony Zietman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

February 2004

Completion Date:

Related Keywords:

  • Prostate Cancer
  • proton beam radiation
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms



Massachusetts General Hospital Boston, Massachusetts  02114-2617