Prostate CancerRO-PIPNCT05614700
Prostate Reirradiation Toxicity Outcomes Feasibility Study
A study testing Brachytherapy and Sterotactic Body Radiotherapy in people with Prostate Cancer and Radiotherapy Side Effect, run by University of Leeds.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Radiotherapy Side Effect
- What is being tested?
- Brachytherapy and Sterotactic Body Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2022to 15 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Reirradiation Options for Previously Irradiated Prostate Cancer (RO-PIP): Feasibility Randomised Clinical Trial Investigating Toxicity Outcomes Following Reirradiation With Ultra-hypofractionated External Beam Radiotherapy vs. High Dose Rate Brachytherapy
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.
Read the 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.
- Conditions
- Prostate Cancer, Radiotherapy Side Effect
- Being tested
- Brachytherapy, Sterotactic Body Radiotherapy
- Medical subject headings
- Prostatic Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrachytherapyRadiation
High Dose-Rate Brachytherapy
Sterotactic Body RadiotherapyRadiation
Hypofractionated External Beam Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Brachytherapy |
| 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. Receives: Radiation: Sterotactic Body Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (2)
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).
Measured: 0-3 months and >3 months
Clinician Reported Toxicity
Incidence of clinician-reported treatment toxicity as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: 0-3 months and >3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start15 Nov 2022 (estimated)
- Primary completion15 Nov 2024 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Feasibility Study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Henry, University of Leeds
- Investigators
- Ann Henry, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614700
- Sponsor's protocol ID
- 21/YH/0305
- Acronym
- RO-PIP
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reirradiation Options for Previously Irradiated Prostate Cancer (RO-PIP): Feasibility Randomised Clinical Trial Investigating Toxicity Outcomes Following Reirradiation With Ultra-hypofractionated External Beam Radiotherapy vs. High Dose Rate Brachytherapy
- ClinicalTrials.gov ID
- NCT05614700
- Acronym / sponsor ID
- RO-PIP / 21/YH/0305
- Conditions
- Prostate Cancer, Radiotherapy Side Effect
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 15 Nov 2022 (estimated)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Feasibility Study
| Arm | Type | Receives |
|---|---|---|
| High dose-rate brachytherapy | Active comparator | Radiation: BrachytherapyTwo 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 | Radiation: Sterotactic Body RadiotherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrachytherapyHigh Dose-Rate Brachytherapy | Radiation | High dose-rate brachytherapy |
| Sterotactic Body RadiotherapyHypofractionated External Beam Radiotherapy | Radiation | Ultra-hypofractionated external beam radiotherapy |
Primary outcome
Treatment Feasibility
Time frame: 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.
2 secondary outcomes
Patient Reported Toxicity
Time frame: 0-3 months and >3 months
Clinician Reported Toxicity
Time frame: 0-3 months and >3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
Related trials for Prostate Cancer
Active, not recruitingPhase 2
Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer
PSA Level Greater Than Two, Stage IV Prostate Adenocarcinoma AJCC v7
RecruitingEarly Phase 1
FTT PET/CT in Metastatic Prostate Cancer
Prostate Cancer Metastatic
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
RecruitingPhase 2
Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro)
Recurrent Prostate Cancer
RecruitingPhase 1/2
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
Liposarcoma, Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ann Henry principal investigator
University of Leeds
Questions about this trial
What is this clinical trial studying?
A study testing Brachytherapy and Sterotactic Body Radiotherapy in people with Prostate Cancer and Radiotherapy Side Effect, run by University of Leeds.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ann Henry (0113 2067630, a.henry@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Feasibility (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.