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

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00855647
• Other study ID #: SU-11022007-792
• Secondary ID: 79432PROS0020
• Status: Completed
• Phase: Phase 2
• First received: March 2, 2009
• Last updated: June 1, 2010
• Start date: August 2003
• Est. completion date: July 2009

Study information

• Verified date: June 2010
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99999
• Est. completion date: July 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Procedure:
• Hypo-fractionated Radiotherapy

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA response that achieves a stable nadir over time.		unknown	No