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Prostate Accurately Targeted Radiotherapy Investigation of Overall Treatment Time

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01423474
Acronym
PATRIOT
Enrollment
152
Registered
2011-08-26
Start date
2012-01-31
Completion date
2019-08-31
Last updated
2024-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasms

Keywords

Radiotherapy, Hypofractionation

Brief 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.

Interventions

40 Gy / 5 fractions / 11 days

Sponsors

Sunnybrook Health Sciences Centre
CollaboratorOTHER
British Columbia Cancer Agency
CollaboratorOTHER
CancerCare Manitoba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Bowel related quality-of-life3 months

Secondary

MeasureTime frameDescription
Gastrointestinal toxicityDuring radiotherapy, at 3 and 6 months, then every 6 months afterRadiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema
Genitourinary toxicityDuring radiotherapy, at 3 and 6 months, then every 6 months afterRadiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema
PSA relapse rate3 and 5 years
Patient Overall Quality of lifeDuring radiotherapy, at 3 and 6 months, then every 6 months after
Salvage androgen deprivation therapy rate3 and 5 years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026