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

Sponsor
Dr. Patrick Cheung (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03526510
Collaborator
(none)
178
1
2
162
1.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: Conventionally Fractionated versus Hypofractionated Boost
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
178 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized TrialRandomized Trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Trial of Concomitant Hypofractionated IMRT Boost Versus Conventional Fractionated IMRT Boost for Localized High Risk Prostate Cancer
Actual Study Start Date :
Jun 1, 2011
Actual Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Acute Toxicity [within 3 months after starting radiotherapy]

    Proportion of patients experiencing grade >=2 acute toxicity

Secondary Outcome Measures

  1. Late Toxicity [beyond 3 months of starting radiotherapy]

    Proportion of patients experiencing grade >= 2 late toxicity

  2. Biochemical Control (Phoenix Definition) [at 5 years]

    Actuarial measure of patients failing biochemically (defined as PSA nadir + 2 ng/mL)

  3. Overall Survival [at 5 years]

    Actuarial measure of patients being alive

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sunnybrook Odette Cancer Centre Toronto Ontario Canada M4N 3M5

Sponsors and Collaborators

  • Dr. Patrick Cheung

Investigators

  • Study Chair: Patrick Cheung, MD, Toronto Sunnybrook Regional Cancer Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Patrick Cheung, Radiation Oncologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT03526510
Other Study ID Numbers:
  • pHART2 RCT
First Posted:
May 16, 2018
Last Update Posted:
Mar 8, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Patrick Cheung, Radiation Oncologist, Sunnybrook Health Sciences Centre
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2022