Trial of Hypofractionated IMRT Boost Versus Conventional IMRT Boost for Localized High Risk Prostate Cancer

Sunnybrook Health Sciences Centre178 enrolled

Overview

Hypofractionation: 48 Gy in 25 fractions to pelvic lymph nodes while the prostate receives 68 Gy in 25 fractions concomitantly. Standard Fractionation: pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy over 39 fractions.

Half the participants will receive using a one phase IMRT plan, the pelvic lymph nodes will be treated to a dose of 48 Gy in 25 fractions, while the prostate will be treated to a dose of 68 Gy in 25 fractions concomitantly (simulataneous integrated boost). The other half of the participants will receive Standard fractionation using 2 sequential IMRT plans, the pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

178

Conditions

Prostate Cancer

Interventions

Hypofractionated IMRT Radiation treatmentRADIATION

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent obtained. * Histologically confirmed diagnosis of adenocarcinoma of the prostate. * Clinical stage T1-2 N0 M0, Gleason Score ≤ 7, PSA 20 - 100 * T1-2 N0 M0, Gleason Score 8 - 10, PSA ≤ 100 * T3 N0 M0, any Gleason Score, PSA ≤ 100 Exclusion Criteria: * Patients with unilateral or bilateral hip replacement. * Patients with active collagen vascular disease. * Patients with active inflammatory bowel disease. * Patients with previous radiotherapy to the pelvis. * Patients with ataxia telangiectasia. * Patients with nodal or distant metastases

Outcomes

Primary Outcomes

Disease free survival

The primary outcome for this study is PSA biochemical disease free survival at 5 years.

Time frame: 5 years

Secondary Outcomes

Late GI and GU toxicities

Number of participants with treatment-related adverse events as assessed by CTCAE v3.0, change from 6 months post treatment to end of 5 year follow-up.

Time frame: 6 month post completion of treatment to end of 5 year follow up

Quality of life outcome: Expanded Prostate Index Composite (EPIC)

Measuring quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. The EPIC questionnaire consists of 50 questions. Each question is scored from 1-5, 5 being the better outcome and 1 being the worst outcome in most of the questions

Time frame: Baseline (start of treatment) to end of 5 year follow-up

Overall survival

Overall survival comparing two treatment arms

Time frame: Baseline to end of 5 year follow-up

Cancer specific survival

Cancer specific survival comparing two treatment arms

Time frame: Baseline to end of 5 year follow-up

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.