Shorter Radiation Schedule for the Treatment of Prostate Cancer

Ontario Clinical Oncology Group (OCOG)

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Procedure: 5250 cGy/20 fractions over 28 days; Procedure: 6600 cGy/33 fractions over 45 days

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT00201916

OCOG-1995-PR.5

CAN-OCOG-V95-0687

Details and patient eligibility

About

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

Full 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.

Enrollment: 936 patients

Sex: Male

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

936 participants in 2 patient groups

1

Experimental group

Description:

5250 cGy in 20 fractions over 28 days

Treatment:

Procedure: 5250 cGy/20 fractions over 28 days

2

Active Comparator group

Description:

6600 cGy in 33 fractions over 45 days

Treatment:

Procedure: 6600 cGy/33 fractions over 45 days