A Phase I/II Study of Escalated-dose Short-course Hypofractionated Radiotherapy (55 Gy/16 Fractions/4 Weeks) for Localized Prostate Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Phase I/II Study of Escalated-dose Short-course Hypofractionated Radiotherapy (55 Gy/16 Fractions/4 Weeks) for Localized Prostate Cancer


This study is aimed at providing further clinical evidence to support or refute the current
understanding of biological sensitivity of prostate cancer to fractionated radiotherapy.
Determining the morbidity and cancer control provided by a 4-week course of treatment will
greatly influence future radiotherapy services for patients with localized prostate cancer.


Inclusion Criteria:



- Stage T1 and T2 prostate cancer

- Prostate specific antigen (PSA)>=20 and Gleason score<=6

- PSA<=15 and Gleason score 7

- Signed informed consent

Exclusion Criteria:

- No hip prosthesis, pins or screws

- No previous pelvic radiotherapy

- No inflammatory bowel disease

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

rectal morbidity

Principal Investigator

Jackson Wu

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Health Services

Authority:

Canada: Health Canada

Study ID:

17885

NCT ID:

NCT00126165

Start Date:

September 2004

Completion Date:

August 2011

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • radiotherapy
  • hypofraction
  • radiosensitivity
  • image-guidance
  • Prostatic Neoplasms

Name

Location