Prostate Reirradiation Toxicity Outcomes Feasibility Study

Status Not yet recruiting

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05614700
Study type	Interventional
Source	University of Leeds
Contact	Ann Henry
Phone	0113 2067630
Email	a.henry@leeds.ac.uk
Status	Not yet recruiting
Phase	N/A
Start date	November 15, 2022
Completion date	November 15, 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05613023` - A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT	Phase 3
Recruiting	`NCT05540392` - An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues	Phase 1/Phase 2
Recruiting	`NCT05156424` - A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer	Phase 1/Phase 2
Completed	`NCT03177759` - Living With Prostate Cancer (LPC)
Completed	`NCT01331083` - A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer	Phase 2
Recruiting	`NCT05540782` - A Study of Cognitive Health in Survivors of Prostate Cancer
Active, not recruiting	`NCT04742361` - Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer	Phase 3
Completed	`NCT04400656` - PROState Pathway Embedded Comparative Trial
Completed	`NCT02282644` - Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry	N/A
Recruiting	`NCT06305832` - Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer	Phase 2
Recruiting	`NCT06037954` - A Study of Mental Health Care in People With Cancer	N/A
Recruiting	`NCT05761093` - Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
Completed	`NCT04838626` - Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection	Phase 2/Phase 3
Recruiting	`NCT03101176` - Multiparametric Ultrasound Imaging in Prostate Cancer	N/A
Completed	`NCT03290417` - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer	N/A
Completed	`NCT00341939` - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Completed	`NCT01497925` - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer	Phase 1
Recruiting	`NCT03679819` - Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Completed	`NCT03554317` - COMbination of Bipolar Androgen Therapy and Nivolumab	Phase 2
Completed	`NCT03271502` - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Prostate Reirradiation Toxicity Outcomes Feasibility Study — RO-PIP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms