PROState Pathway Embedded Comparative Trial

NCT04400656 | Completed Results DMC

• 1 other identifier: 19CX5601
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 3

Brief Summary

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

Prostate Cancer; Non-metastatic Prostate Cancer; Metastatic Prostate Cancer; Prostate Adenocarcinoma; Metastatic Prostate Carcinoma in the Soft Tissue; Prostate Cancer Metastatic

Keywords

prostate cancer; Non-metastatic Prostate Cancer; Metastatic Prostate Cancer; Prostate Adenocarcinoma; Metastatic Prostate Carcinoma in the Soft Tissue; Prostate Cancer Metastatic; Clinical Trial Design; cohort multiple randomised controlled trial; cmRCT; Trials Within Cohorts; TWICS

Outcome Measures

Primary Outcomes (6)

• Number of Men Who Consented to Inclusion in PROSPECT Study Out of Total Number of Patients Approached

  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.

  from baseline to 23 months

• Number of Participants Approached for the Study From the Number of Patients Referred to the Study Team by Other Participating Centres

  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.

  from baseline to 23 months

• Number of Participants Who Complete a Questionnaire on the Quality of Life (EQ5D-5L)

  Number of Participants who complete a given standard Quality of Life Questionnaire (EQ5D-5L) at the point at which they consent to inclusion into PROSPECT. (Baseline Visit)

  Questionnaire was completed at baseline - 0 months, visit 1 - 6 months, visit 2 -12 months and visit 3 -18 months.

• Number of Participants Who Complete a Questionnaire on Quality of Life (EPIC-26)

  Number of Participants who completed a given standard Quality of Life Questionnaire (EPIC-26) at the point at which they consent to inclusion into PROSPECT. (Baseline Visit)

  Questionnaire was completed at baseline - 0 months, visit 1 - 6 months, visit 2 -12 months and visit 3 -18 months.

• Number of Participants Who Complete a Questionnaire on Quality of Life (IPSS)

  Number of Participants who complete a given standard Quality of Life Questionnaire (IPSS) at the point at which they consent to inclusion into PROSPECT.

  Questionnaire was completed at baseline - 0 months, visit 1 - 6 months, visit 2 -12 months and visit 3 -18 months.

• Number of Participants Who Complete a Questionnaire on Quality of Life (IIEF-15)

  Number of Participants who completed a given standard Quality of Life Questionnaire (IIEF-15) at the point at which they consent to inclusion into PROSPECT. (Baseline Visit)

  Questionnaire was completed at baseline - 0 months, visit 1 - 6 months, visit 2 -12 months and visit 3 -18 months.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Men with possible prostate malignancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All men referred for investigation of prostate cancer

You may qualify if:

• 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.
• An understanding of the English language sufficient to understand written and verbal information about the trial and consent process.
• Estimated life expectancy of 5 years or more.
• Signed informed consent.

You may not qualify if:

• \. Men who are unable to give informed consent.

Sponsors & Collaborators

• Imperial College London: lead
• Imperial Clinical Trials Unit (ICTU): collaborator
• Wellcome Trust: collaborator

Study Sites (3)

West Middlesex University Hospital

Isleworth, Middlesex, TW7 6AF, United Kingdom

Location

Ashford & St Peter's Hospitals (ASPH) NHS Foundation Trust

Chertsey, Surrey, KT16 0PZ, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W6 8RF, United Kingdom

Location

Related Publications (1)

• Peters 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 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Ms Puja Jadav
• Organization: Imperial College London

p.jadav@imperial.ac.uk

0203 311 5473

Study Officials

• Hashim Ahmed

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 22, 2020
• Study Start: September 8, 2020
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: June 18, 2025
• Results First Posted: June 18, 2025

Record last verified: 2025-06

Locations

GB (3)