Health TrialsbyHealthPanel

Prostate Adaptive Radiation Therapy

ConditionProstatic Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorRoyal North Shore Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

- Age > 18

Biopsy proven prostate malignancy

Definitive treatment is radiotherapy to the prostate alone

ECOG performance status 0-2

Disqualifiers

Hip prosthesis

Patient separation from prostate centre to skin edge > 24cm, measured on diagnostic scan-

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adaptive radiotherapy +/- Margin Reduction

    Radiation

    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

    Radiation

    Standard radiation treatment used in the department of radiation oncology for prostate cancer

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Adaptive radiotherapy +/- margin reductionActive comparator 1 intervention
Group B: Standard radiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety of Adaptive Radiation Therapy via Radiation Therapists-led* treatment delivery (CTV coverage)

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).

Time frame
12 months
2

Safety of Adaptive Radiation Therapy via Radiation Therapists-led* treatment delivery (OAR DVH constraints)

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.

Time frame
12 months
3

Feasibility of ART via RT-led* treatment delivery

At least 90% of patients must have 90% of planned adaptive treatments successfully delivered in phase 1 of the study.

Time frame
12 months
4

Acute patient reported toxicity

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.

Time frame
Within 90 days of patients completing treatment

Secondary outcomes

1

Acute clinician reported toxicity

The study will measure the difference in acute combined maximum GU and GI toxicity (Grade 2 or higher) grading between the two treatment arms as reported by clinicians using CTCAE v5.0

Time frame
Within 90 days of patients completing treatment
2

Late clinician reported toxicity

The study will measure the difference in late GU and GI toxicity (Grade 2 or higher) between the two treatment arms as reported by clinicians using CTCAE v5.0

Time frame
5 years
3

Late patient reported toxicity

The study will measure the difference in patient reported late GU and GI toxicity (Grade 2 or higher) between the two treatment arms as per PRO-CTCAE.

Time frame
5 years
4

Biochemical progression Free Survival

The rate of biochemical failure as defined as Nadir+2.0, commencement of ADT for relapse or evidence of disease recurrence on imaging

Time frame
3 and 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Royal North Shore Hospital

Lead sponsor

Northern Sydney and Central Coast Area Health Service

Collaborator

Source ClinicalTrials.gov
Apply now