Clinical trial · Observational
PROState Pathway Embedded Comparative Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The proposal will explore a trial design called the cohort-multiple RCT (cmRCT) or as it has been recently coined, the Trials WithIn Cohorts (TWICS) design. This design has been used in a number of disease areas, both benign and cancer. Prostate conditions have been chosen since they are extremely common and if malignancy occurs the majority of men with the disease are regarded as living with a chronic condition due to its long natural history and in which innovative approaches, interventions, treatments or changes in management might have a significant patient benefit and impact on the NHS. It therefore fits the cmRCT design very well. Nonetheless, the lessons learned in this study will be of relevance to other disease spaces. The TWICS or cmRCT design is currently being used in elderly patients, risk of falls, depression, hip fracture, Yorkshire Health Study, scleroderma, breast cancer, colorectal cancer, bladder cancer and kidney cancer, to name a few. In total, a recent systematic review showed that there were 18 ongoing cmRCT studies with 6 in the UK. The acceptability and feasibility of the cmRCT in the prostate pathway will be tested. This is the first time this method will be tested and therefore piloted. In the first part of the study, the following will be evaluated. What is the accrual rate? What do patients and their healthcare professionals think of the cmRCT design? Is the data collected robust? What are the resource requirements of such a study?A number of novel interventions or changes in the pathway will then be tested and compared to standard care in the cohort that was recruited.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Prostate Carcinoma in the Soft Tissue | — | UNRESOLVED | — |
| Non-metastatic Prostate Cancer | — | UNRESOLVED | — |
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- Number of Men Who Consented to Inclusion in PROSPECT Study Out of Total Number of Patients Approached
- timeFrame
- from baseline to 23 months
- description
- Number of men who consented to inclusion in PROSPECT Study out of total number of patients approached at the original point of contact by the research team.
- measure
- Number of Participants Approached for the Study From the Number of Patients Referred to the Study Team by Other Participating Centres
- timeFrame
- from baseline to 23 months
- description
- Evaluation of the number of men approached to enter the PROSPECT Study from the number of men referred to the participating centres for investigation of prostate cancer.
- measure
- Number of Participants Who Complete a Questionnaire on the Quality of Life (EQ5D-5L)
- timeFrame
- Questionnaire was completed at baseline - 0 months, visit 1 - 6 months, visit 2 -12 months and visit 3 -18 months.
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men aged 18 years old and over who are referred for investigations for urinary symptoms or elevated serum prostate specific antigen (PSA) levels or other risk factors for possible prostate malignancy. 2. An understanding of the English language sufficient to understand written and verbal information about the trial and consent process. 3. Estimated life expectancy of 5 years or more. 4. Signed informed consent. Exclusion Criteria: 1\. Men who are unable to give informed consent.
References
Publications (1)
- DERIVEDPeters M, Eldred-Evans D, Kurver P, Falagario UG, Connor MJ, Shah TT, Verhoeff JJC, Taimen P, Aronen HJ, Knaapila J, Montoya Perez I, Ettala O, Stabile A, Gandaglia G, Fossati N, Martini A, Cucchiara V, Briganti A, Lantz A, Picker W, Haug ES, Nordstrom T, Tanaka MB, Reddy D, Bass E, van Rossum PSN, Wong K, Tam H, Winkler M, Gordon S, Qazi H, Bostrom PJ, Jambor I, Ahmed HU. Predicting the Need for Biopsy to Detect Clinically Significant Prostate Cancer in Patients with a Magnetic Resonance Imaging-detected Prostate Imaging Reporting and Data System/Likert >/=3 Lesion: Development and Multinational External Validation of the Imperial Rapid Access to Prostate Imaging and Diagnosis Risk Score. Eur Urol. 2022 Nov;82(5):559-568. doi: 10.1016/j.eururo.2022.07.022. Epub 2022 Aug 11. PMID 35963650