Hypofractionated Radiotherapy for Localized Prostate Cancer (With CyberKnife or With IMRT)

Stanford University

Status and phase

Completed

Phase 2

Conditions

Prostatic Neoplasms

Treatments

Procedure: Hypo-fractionated Radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00855647

PROS0020

79432

NCT00855647

SU-11022007-792

Details and patient eligibility

About

To demonstrate that a hypo-fractionated course of radiotherapy (ie. an accelerated radiotherapy course where fewer but larger doses of radiotherapy are given) is both safe and effective in the treatment of low-risk localized prostate cancer.

Enrollment

99,999 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:- Eligible patients will have clinical stage T1c through T2b, initial PSA level <10 and a biopsy Gleason score of 3+3 or 3+4 with fewer than 50% of biopsy cores involved.

Patients who have had any form of prior curative treatment (surgery, radiotherapy, cryotherapy) will not be eligible. A prior course of hormone therapy of less than 3 months duration will be allowed.
Adult men will be considered.
No life expectancy restrictions will apply.
Performance Status will not be considered.
No requirements for organ or marrow function will be made
Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria:- No prior prostate treatment will be allowed.
The use of other concurrent Investigational Agents will not be allowed.
No exclusion requirements due to co-morbid disease or incurrent illness.
No requirements regarding history of allergic reactions.
Pregnancy or nursing patients is not applicable (ie. patients are male).