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

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: Hypofractionated IMRT Radiation treatment

• Registration Number: NCT04239599
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2011-03-31
• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2020-01-23
• Study First Posted: 2020-01-27
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-29
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 178

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypofractionation	Hypofractionated IMRT Radiation treatment	Hypofractionation: 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) + 18-36 months of Eligard Hormone injection.
Standard Fractination	Hypofractionated IMRT Radiation treatment	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 + 18-36 months of Eligard Hormone injection.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Late GI and GU toxicities	6 month post completion of treatment to end of 5 year follow up	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.
Quality of life outcome: Expanded Prostate Index Composite (EPIC)	Baseline (start of treatment) to end of 5 year follow-up	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
Overall survival	Baseline to end of 5 year follow-up	Overall survival comparing two treatment arms
Cancer specific survival	Baseline to end of 5 year follow-up	Cancer specific survival comparing two treatment arms