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Completed

NCT Number: NCT01423474

Prostate Accurately Targeted Radiotherapy Investigation of Overall Treatment Time

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.

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

BC Cancer Agency - Abbotsford Centre, Abbotsford British Columbia, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Image-guided Radiotherapy

Radiation

40 Gy / 5 fractions / 11 days

Primary outcomes

  1. Bowel related quality-of-life

    Time frame: 3 months

Secondary outcomes

  1. Gastrointestinal toxicity

    Time frame: During radiotherapy, at 3 and 6 months, then every 6 months after

    Radiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema

  2. Genitourinary toxicity

    Time frame: During radiotherapy, at 3 and 6 months, then every 6 months after

    Radiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema

  3. PSA relapse rate

    Time frame: 3 and 5 years

  4. Patient Overall Quality of life

    Time frame: During radiotherapy, at 3 and 6 months, then every 6 months after

  5. Salvage androgen deprivation therapy rate

    Time frame: 3 and 5 years

Sponsors and collaborators

Lead sponsor

CancerCare Manitoba

Other

Collaborators

  • British Columbia Cancer Agency
  • Sunnybrook Health Sciences Centre

Registry information

Official study title

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

Acronym: PATRIOT

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Aug 26, 2011
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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