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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: Conventionally Fractionated versus Hypofractionated Boost

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 Type: Interventional
• Enrollment (Actual): 178
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Odette Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Radiation: Conventionally Fractionated versus Hypofractionated Boost
Experimental: 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).	Radiation: Conventionally Fractionated versus Hypofractionated Boost

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Toxicity	Proportion of patients experiencing grade >=2 acute toxicity	within 3 months after starting radiotherapy

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dr. Patrick Cheung
• Investigators: Study Chair: Patrick Cheung, MD, Toronto Sunnybrook Regional Cancer Centre

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2011
• Primary Completion (Actual): November 1, 2021
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: May 3, 2018
• First Submitted That Met QC Criteria: May 3, 2018
• First Posted (Actual): May 16, 2018

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: March 6, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Radiotherapy; High Risk Prostate Cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: pHART2 RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No