Prostate Cancer, Radiotherapy Side Effect
Conditions
Brief summary
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.
Detailed description
Radiotherapy is the most common curative treatment for non-metastatic prostate cancer, however up to 13% of patients will develop local recurrence within 10 years. Patients can undergo further and potentially curative treatment including salvage surgery, brachytherapy (BT), external beam radiotherapy (EBRT), high intensity focused ultrasound and cryotherapy. Systematic review shows that high dose rate (HDR) BT and stereotactic body radiotherapy (SBRT) have the best outcomes in terms of biochemical control and lowest side effects. The RO-PIP trial aims to determine the feasibility of recruitment to a trial randomising patients to salvage HDR-BT or SBRT and provide prospective data on patient recorded toxicity outcomes that will inform a future phase III trial. The primary endpoint of the RO-PIP feasibility study is to evaluate the patient recruitment potential over 2 years to a trial randomising to either SBRT or HDR-BT for patients who develop local recurrence of prostate cancer following previous radiation therapy. The aim is to recruit 60 patients across 3 sites over 2 years and randomise 1:1 to SBRT or HDR-BT. Secondary objectives include recording clinician and patient reported outcome measures (PROMs) to evaluate treatment-related toxicity. In addition, the study aims to identify potential imaging, genomic and proteomic biomarkers that are predictive of toxicity and outcome based on hypoxia status, a prognostic marker of prostate cancer.
Interventions
RADIATIONBrachytherapy
High Dose-Rate Brachytherapy
RADIATIONSterotactic Body Radiotherapy
Hypofractionated External Beam Radiotherapy
Sponsors
University of Leeds
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomised Feasibility Study
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * World Health Organisation (WHO) performance status 0-2 * Reasonable urinary function (IPSS \< 20 and Qmax \> 10 ml/second on flow tests) * Greater than 10 year life expectancy
Exclusion criteria
* 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 * Prior prostatectomy * History of inflammatory bowel disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Feasibility | 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Toxicity | 0-3 months and >3 months | 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). |
| Clinician Reported Toxicity | 0-3 months and >3 months | Incidence of clinician-reported treatment toxicity as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Imaging biomarkers | 1 month and 12 months | MRI biomarkers at 1 month and 1 year post-treatment predictive of toxicity based on PROMs. |
| Proteomic Biomarkers | Baseline, 1, 3 and 6 months | Changes in the levels of inflammatory cytokine signatures from urine and blood obtained at baseline and after reirradiation in relation to PROMs. |
| Imaging Reproducibility | Baseline, 1 and 12 months | 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. |
| Hypoxia Gene Signature | Baseline | Hypoxia levels based on a hypoxia associated gene signature obtained from the pre-salvage RT biopsy correlated with MRI biomarkers. |
Contacts
Primary ContactAnn Henry
Backup ContactJim Zhong
Outcome results
None listed