Hypofractionated Boost vs Conventionally Fractionated Boost for Localized High Risk Prostate Cancer

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: Conventionally Fractionated versus Hypofractionated Boost

• Registration Number: NCT03526510
• Lead Sponsor: Dr. Patrick Cheung

Brief Summary

Randomized trial comparing 2 external beam radiotherapy fractionation schemes in patients with localized high risk prostate cancer. Primary endpoint is acute toxicity.

Detailed Description

Patients enrolled onto this study will be randomized to one of the following treatment arms:

* 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.

* 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).

In addition, all patients receive 1.5- 3 years of androgen deprivation therapy.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2018-05-03
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-16
• Primary Completion: 2021-11
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-06
• Last Update Posted: 2022-03-08
• Study Completion: 2024-12

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.
• 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
Standard Fractionation	Conventionally Fractionated versus Hypofractionated Boost	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.
Hypofractionation	Conventionally Fractionated versus Hypofractionated Boost	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).

Primary Outcome Measures

Name	Time	Method
Acute Toxicity	within 3 months after starting radiotherapy	Proportion of patients experiencing grade \>=2 acute toxicity

Secondary Outcome Measures

Name	Time	Method
Biochemical Control (Phoenix Definition)	at 5 years	Actuarial measure of patients failing biochemically (defined as PSA nadir + 2 ng/mL)
Overall Survival	at 5 years	Actuarial measure of patients being alive
Late Toxicity	beyond 3 months of starting radiotherapy	Proportion of patients experiencing grade \>= 2 late toxicity

Trial Locations

Locations (1)

Sunnybrook Odette Cancer Centre; 🇨🇦 Toronto, Ontario, Canada