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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose-rate brachytherapy | Active Comparator | Two HDR-BT treatment schedules, either a single fraction 19Gy treatment or 27Gy in 2 fractions approximately 2 weeks apart will be used to be decided by treating centre. |
|
| Ultra-hypofractionated external beam radiotherapy | Experimental | Patients will receive 5 fractions of 7.25Gy per fraction which will be delivered alternate days over no more than 2 weeks to provide a total dose of 36.25Gy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brachytherapy | Radiation | High Dose-Rate Brachytherapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 0-3 months and >3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Imaging biomarkers | MRI biomarkers at 1 month and 1 year post-treatment predictive of toxicity based on PROMs. | 1 month and 12 months |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ann Henry | Contact | 0113 2067630 | a.henry@leeds.ac.uk | |
| Jim Zhong | Contact | 0113 2067630 | j.zhong@leeds.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Ann Henry | University of Leeds | Principal Investigator |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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Randomised Feasibility Study
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| Sterotactic Body Radiotherapy |
| Radiation |
Hypofractionated External Beam Radiotherapy |
|
| Clinician Reported Toxicity | Incidence of clinician-reported treatment toxicity as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | 0-3 months and >3 months |
| Baseline, 1 and 12 months |
| Hypoxia Gene Signature | Hypoxia levels based on a hypoxia associated gene signature obtained from the pre-salvage RT biopsy correlated with MRI biomarkers. | Baseline |
| Proteomic Biomarkers | Changes in the levels of inflammatory cytokine signatures from urine and blood obtained at baseline and after reirradiation in relation to PROMs. | Baseline, 1, 3 and 6 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014947 | Wounds and Injuries |