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

NCT03526510 | Unknown

• 1 other identifier: pHART2 RCT
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Keywords

High Risk Prostate Cancer; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Acute Toxicity

  Proportion of patients experiencing grade \>=2 acute toxicity

  within 3 months after starting radiotherapy

Secondary Outcomes (3)

• Late Toxicity

  beyond 3 months of starting radiotherapy

• Biochemical Control (Phoenix Definition)

  at 5 years

• Overall Survival

  at 5 years

Study Arms (2)

Standard Fractionation

ACTIVE COMPARATOR

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

Hypofractionation

EXPERIMENTAL

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

Interventions

Conventionally Fractionated versus Hypofractionated Boost RADIATION

Hypofractionation; Standard Fractionation

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Patrick Cheung: lead

Study Sites (1)

Sunnybrook Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Patrick Cheung, MD

  Toronto Sunnybrook Regional Cancer Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Radiation Oncologist

Model Details: Randomized Trial

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 16, 2018
• Study Start: June 1, 2011
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2024
• Last Updated: March 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)