Prostate Accurately Targeted Radiotherapy Investigation of Overall Treatment Time

Prostatic Neoplasms Clinical Trial

— PATRIOT  

Official title:

Randomized Phase II Study of 2 Hypofractionated Radiotherapy Schedules for Low- and Intermediate-Risk Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01423474
• Other study ID #: 50-2011
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: August 2019

Study information

• Verified date: February 2024
• Source: CancerCare Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the toxicity of two new radiation schedules for the treatment of prostate cancer. Patients will be randomized to receive 5 treatments delivered every other day over 11 days, or once per week over 29 days. Both of these schedules are shorter than the standard treatment which is usually 39 treatments over 8 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Low or intermediate risk prostate cancer patients as defined by:

• Clinical stage T1-2b, Gleason Score <=7, and PSA <=20 ng/mL

• Age >= 18 years

Exclusion Criteria:

• Androgen deprivation therapy (LHRH-agonists or antiandrogens) >6 months

• Prior pelvic radiotherapy

• Anticoagulation medication (if unsafe to discontinue for gold seed insertion)

• Diagnosis of bleeding diathesis

• Large prostate (>90cm3) on imaging

• Immunosuppressive medications

• Inflammatory bowel disease

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Radiation:
• Image-guided radiotherapy
40 Gy / 5 fractions / 11 days
• Image-guided radiotherapy
40 Gy / 5 fractions / 29 days

Locations

Country	Name	City	State
Canada	BC Cancer Agency - Abbotsford Centre	Abbotsford	British Columbia
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	CancerCare Manitoba	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
CancerCare Manitoba	British Columbia Cancer Agency, Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel related quality-of-life		3 months
Secondary	Gastrointestinal toxicity	Radiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema	During radiotherapy, at 3 and 6 months, then every 6 months after
Secondary	Genitourinary toxicity	Radiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema	During radiotherapy, at 3 and 6 months, then every 6 months after
Secondary	PSA relapse rate		3 and 5 years
Secondary	Patient Overall Quality of life		During radiotherapy, at 3 and 6 months, then every 6 months after
Secondary	Salvage androgen deprivation therapy rate		3 and 5 years