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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostatic Neoplasms

Thank you

Trial Information

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


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).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

PSA response that achieves a stable nadir over time.

Outcome Time Frame:

unknown

Safety Issue:

No

Principal Investigator

Christopher R. King

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Food and Drug Administration

Study ID:

SU-11022007-792

NCT ID:

NCT00855647

Start Date:

August 2003

Completion Date:

July 2009

Related Keywords:

  • Prostatic Neoplasms
  • Neoplasms
  • Prostatic Neoplasms

Name

Location

Stanford University School of MedicineStanford, California  94305-5317