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

Prostate Cancer Clinical Trial

— RCT-PHART2  

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: NCT04239599
• Other study ID #: RCT- PHART2
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 31, 2011
• Est. completion date: December 31, 2023

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 178
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• 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.

• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Hypofractionated IMRT Radiation treatment

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival	The primary outcome for this study is PSA biochemical disease free survival at 5 years.	5 years
Secondary	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
Secondary	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
Secondary	Overall survival	Overall survival comparing two treatment arms	Baseline to end of 5 year follow-up
Secondary	Cancer specific survival	Cancer specific survival comparing two treatment arms	Baseline to end of 5 year follow-up