Shorter Radiation Schedule for the Treatment of Prostate Cancer

A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00201916

Enrollment

936

Registered

2005-09-20

Start date

1995-03-31

Completion date

2009-12-31

Last updated

2010-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate cancer, prostate specific antigen, PSA, radiation fractionation

Brief summary

To improve the management of patients with early stage prostate cancer.

Detailed description

To compare the efficacy of a shorter radiation fractionation schedule to the prostate (5250 cGy/20 fractions over 28 days) with a conventional schedule (6600 cGy/33 fractions over 45 days) in men receiving radiotherapy for Stage T1a moderately or poorly differentiated, or T1b, T1c, or T2 prostate cancer. The primary outcome is local control in the prostate and secondary outcomes include toxicity, disease free survival, survival, quality of life and economics.

Interventions

PROCEDURE5250 cGy/20 fractions over 28 days

see above

PROCEDURE6600 cGy/33 fractions over 45 days

see above

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Healthy volunteers

Inclusion criteria

* histologic diagnosis of adenocarcinoma of the prostate with no evidence of metastatic disease to the nodes, bone or lung * stage T1a moderately or poorly differentiated, T1b, T1c or T2 by the current UICC-TNM classification

Exclusion criteria

* PSA \> 40 mcg/L * previous therapy for carcinoma of the prostate other than biopsy or TURP, including patients previously on hormone therapy for treatment of their prostate cancer * prior or active malignancy other than non-melanoma skin cancer; or colon or thyroid cancer treated a minimum of five years prior to study entry and presumed cured * simulated volume exceeds 1000 cm3 * previous pelvic radiotherapy * inflammatory bowel disease * serious non-malignant disease which would preclude radiotherapy or surgical biopsy * geographic inaccessibility for follow-up * psychiatric or addictive disorder which would preclude obtaining informed consent or adherence to protocol * unable to commence radiation therapy within 26 weeks of the date of last prostatic biopsy * failure to give informed consent to participate in the study

Design outcomes

Primary

Measure	Time frame
time to PSA failure	10 years

Secondary

Measure	Time frame
positive biopsy at two years post radiation	see above
disease free survival	10 years
toxicity	10 years
quality of life	6 years
economic	10 years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026