Trial of Hypofractionated IMRT Boost Versus Conventional IMRT Boost for Localized High Risk Prostate Cancer (RCT-PHART2)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: Hypofractionated IMRT Radiation treatment

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

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.
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Hypofractionation; 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.	Radiation: Hypofractionated IMRT Radiation treatment; Other Names: Eligard 22.5 mg (28.2 mg leuprolide acetate per syringe) [3-Month] for 18-36 months
ACTIVE_COMPARATOR: Standard Fractination; 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.	Radiation: Hypofractionated IMRT Radiation treatment; Other Names: Eligard 22.5 mg (28.2 mg leuprolide acetate per syringe) [3-Month] for 18-36 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival	The primary outcome for this study is PSA biochemical disease free survival at 5 years.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Baseline (start of treatment) to end of 5 year follow-up
Overall survival	Overall survival comparing two treatment arms	Baseline to end of 5 year follow-up
Cancer specific survival	Cancer specific survival comparing two treatment arms	Baseline to end of 5 year follow-up

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Sanofi
• Investigators: Principal Investigator: Patrick Cheung, MD, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start: March 31, 2011
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: January 23, 2020
• First Posted (ACTUAL): January 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Leuprolide
• Other Study ID Numbers: RCT- PHART2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share Individual Participant data. Results from the trial will be available through publications.

Drug and device information, study documents

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