Prostate Adaptive Radiation Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

Adaptive radiotherapy +/- Margin Reduction: Radiotherapy using adaptive technology to recontour and replan daily as required. Reductions in the PTV margin will also be introduced in the second phase of this study.

Image guided radiotherapy: Standard radiation treatment used in the department of radiation oncology for prostate cancer

Study summary

Prostate ART is a two phase study looking at using adaptive radiotherapy to help reduce toxicity for prostate cancer patients.

Adaptive radiotherapy is a new technology that provides the ability to account for daily changes in anatomy. Adaptive radiotherapy also provides a foundation for which radiotherapy margins might be safely reduced.

Phase 1 of this study is looking to see if a radiation therapist centred adaptive workflow can be implemented. If phase 1 of this study is safe and feasible, the study will proceed to phase 2.

Part 2 of the study looks at using adaptive technology to reduce radiation treatment margins. The primary aim of this study is to see whether margin reduced treatment using adaptive radiotherapy can reduce side effects for prostate cancer patients.

Eligibility

Primary outcome measure(s)

• Safety of Adaptive Radiation Therapy via Radiation Therapists-led* treatment delivery (CTV coverage) — 12 months
  A comparison of Clinical Target Volume (CTV) dose coverage will be performed. The CTV dose coverage must be equal or better in 90% of fractions for 90% of patients compared with the virtual image guided radiotherapy (IGRT) fraction. Dose coverage will be calculated as the percent of CTV receiving at least 95% of the prescribed dose (TD).
• Safety of Adaptive Radiation Therapy via Radiation Therapists-led* treatment delivery (OAR DVH constraints) — 12 months
  A comparison of organ at risk (OAR) dose-volume histogram (DVH) constraints will be performed. The OAR DVH dose constraints must be equal or better in 90% of fractions for 90% of patients compared with the virtual image guided radiotherapy (IGRT) fraction.
• Feasibility of ART via RT-led* treatment delivery — 12 months
  At least 90% of patients must have 90% of planned adaptive treatments successfully delivered in phase 1 of the study.
• Acute patient reported toxicity — Within 90 days of patients completing treatment
  The study will measure the difference in patient reported combined maximum GU and GI toxicity (Grade 2 or higher) as per PRO-CTCAE between the two treatment arms.

Trial sites (1)

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