Prostate Accurately Targeted Radiotherapy Investigation of Overall Treatment Time (PATRIOT)

CancerCare Manitoba

Status: Completed

Conditions: Prostatic Neoplasms

Treatments: Radiation: Image-guided radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01423474

50-2011

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 2 patient groups

Short treatment time (11 days)

Experimental group

Treatment:

Radiation: Image-guided radiotherapy

Radiation: Image-guided radiotherapy

Long treatment time (29 days)

Experimental group

Treatment:

Radiation: Image-guided radiotherapy

Radiation: Image-guided radiotherapy