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Prostate Reirradiation Toxicity Outcomes Feasibility Study

ConditionsProstate CancerRadiotherapy Side Effect
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Leeds

About this trial

The RO-PIP trial aims to determine the feasibility of recruitment to a trial randomising patients to salvage ultra-hypofractionated external beam radiotherapy or high dose rate brachytherapy and provide prospective data on patient recorded toxicity outcomes that will inform a future phase III trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male individuals aged over 18 years

Histologically confirmed locally recurrent prostate cancer (following previous radiotherapy no less than 2 years ago)

No metastatic disease

Able and willing to provide an informed consent to participate

Disqualifiers

Patients who are unfit for a general anaesthetic due to other comorbidities

Clinical or radiological evidence of metastatic prostate disease

Any patient with a medical or psychiatric condition that impairs their ability to give informed consent

Contraindication or intolerance of magnetic resonance scanning

Trial design

Design model

Parallel

Treatments tested in this trial

  • Brachytherapy

    Radiation

    High Dose-Rate Brachytherapy

  • Sterotactic Body Radiotherapy

    Radiation

    Hypofractionated External Beam Radiotherapy

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: High dose-rate brachytherapyActive comparator 1 intervention
Group B: Ultra-hypofractionated external beam radiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Treatment Feasibility

Recruitment rates for the whole 24-month recruitment period will be reported overall and per recruiting site. The average recruitment rate per month and in total over the formal monitoring period will be reported.

Time frame
24 months

Secondary outcomes

1

Patient Reported Toxicity

Incidence of patient reported acute (0-3 months) and long-term toxicity (\>3 months) and impact on QoL determined by EPIC-26 (prostate cancer related QoL and functional outcomes), EORTC QLQ-C30 (general QoL score) and international prostate symptom score (IPSS) (urinary and sexual functional outcomes) measurements (Key secondary endpoint).

Time frame
0-3 months and >3 months
2

Clinician Reported Toxicity

Incidence of clinician-reported treatment toxicity as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Time frame
0-3 months and >3 months

Other outcomes

1

Imaging biomarkers

MRI biomarkers at 1 month and 1 year post-treatment predictive of toxicity based on PROMs.

Time frame
1 month and 12 months
2

Imaging Reproducibility

Multiple measures of image quality and reproducibility of prostate functional imaging (e.g. diffusion coefficient values from IVIM sequences) for measuring tumour biology will be summarised.

Time frame
Baseline, 1 and 12 months
3

Hypoxia Gene Signature

Hypoxia levels based on a hypoxia associated gene signature obtained from the pre-salvage RT biopsy correlated with MRI biomarkers.

Time frame
Baseline
4

Proteomic Biomarkers

Changes in the levels of inflammatory cytokine signatures from urine and blood obtained at baseline and after reirradiation in relation to PROMs.

Time frame
Baseline, 1, 3 and 6 months

Locations

This trial has no locations.

Sponsors and contacts

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

University of Leeds

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: