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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03526510
• Other study ID #: pHART2 RCT
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2011
• Est. completion date: December 2024

Study information

• Verified date: March 2022
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 178
• Est. completion date: December 2024
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Conventionally Fractionated versus Hypofractionated Boost

Locations

Country	Name	City	State
Canada	Sunnybrook Odette Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Patrick Cheung

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Toxicity	Proportion of patients experiencing grade >=2 acute toxicity	within 3 months after starting radiotherapy
Secondary	Late Toxicity	Proportion of patients experiencing grade >= 2 late toxicity	beyond 3 months of starting radiotherapy
Secondary	Biochemical Control (Phoenix Definition)	Actuarial measure of patients failing biochemically (defined as PSA nadir + 2 ng/mL)	at 5 years
Secondary	Overall Survival	Actuarial measure of patients being alive	at 5 years