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Completed

NCT Number: NCT02034955

Prostatectomy Adaptive Radiation Therapy (ART)

This study will ultimately aim to evaluate the side effects of treatment by asking 20 subjects to receive post-operative radiotherapy for prostate cancer with the treatment plan adapted after the first week of treatment to account for changes in the target shape. These patients will be asked to complete toxicity scores and a quality of life questionnaire at the start and completion of treatment, and at 3 months 1, 2 and 5 years from the start of radiotherapy. These results will be used to determine the feasibility of the proposed approach, and obtain early estimates of improvements in uncertainty margin requirements for this population of patients.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologic diagnosis of adenocarcinoma of the prostate after radical prostatectomy AND
  • Clinical stage pT3, pT4, or pT2 with positive margin OR
  • Any p-Stage with a persistently elevated post-operative PSA > 0.05 ng/ml OR
  • A delayed rise in PSA post-operatively

Exclusion criteria

  • Inflammatory bowel disease or other contraindications to radiotherapy
  • Prior pelvic radiotherapy
  • Previous cytotoxic chemotherapy
  • Radiological or pathologic evidence of nodal metastases.
  • Planned radiotherapy to pelvic lymph nodes
  • Evidence of systemic metastases on imaging.
  • Prosthetic hip replacement
  • No signed informed consent

Treatment and study plan

Post-operative Adaptive Radiation Therapy

Radiation

Other names: All Patients enrolled in this study will have additional scans (Cone-Beam CT,MRI) daily during their treatment. This extra imaging will help us see any, changes that might have occurred during radiation treatment and update the treatment plan to include these changes before patient treatment is continued.

Primary outcomes

  1. Change in radiation dose delivered to target volumes and normal tissue

    Time frame: 5 years

Secondary outcomes

  1. Time for radiotherapy replanning

    Time frame: 5 years

  2. Volumetric modulated arc therapy impact in a clinical adaptive Radiotherapy workflow.

    Time frame: 5 years

    Feasibility will be assessed by the time required to perform the adaptive intervention

  3. Toxicity associated with the adaptive radiotherapy technique.

    Time frame: 5 years

    Assessments of gastrointestinal and genitourinary complications using the Common Toxicity Criteria for Adverse Events scoring system and the Expanded Prostate Cancer Index Composite questionnaire.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

A Feasibility Study of Post-operative Adaptive Radiation Therapy for Localized Prostate Cancer

Important dates

Study start
2013
Primary completion
2023
Study completion
2023
First posted
Jan 14, 2014
Registry last updated
Mar 18, 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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