The PROSECCA Study, Answering New Questions in Prostate Cancer

NCT06714630 | Recruiting

• 1 other identifier: 2022/0221
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief Summary

Nearly half of all cancer patients receive radiotherapy as part of their treatment and although it is effective at destroying cancerous lesions deep within the body, this comes at the cost of damaging healthy, or normal, tissues. With 50% of cancer patients surviving for 10 years or more, these patients can be left with life-changing side effects from their radiotherapy. It is clear that more must be done to limit damage to normal healthy tissue without compromising annihilation of the tumour and curing patients. The key to this is personalising an individual's radiotherapy treatment, in other words rather than assuming that all tumours respond similarly to radiotherapy, the treatment is optimised for an individual. To date, approaches to do this have been restricted to small numbers of carefully selected patients, are inordinately expensive, and not suitable for rolling out into everyday practice across the NHS. There is however another way, namely using Artificial Intelligence (AI) combined with an individual's healthcare record. By linking together large numbers of healthcare records at a national level, combined with the power of AI, the PROSECCA project will transform radiotherapy and cancer care.

Conditions

Prostate Cancer

Keywords

Artificial Intelligence; Radiotherapy reactions; clinical decisions; predict outcomes; Patient individualised response; Machine Learning; AI; Personalized Radiotherapy; Radiotherapy Adaptation

Outcome Measures

Primary Outcomes (3)

• PSA relapse free survival

  PSA relapse free survival will be measured from the date of treatment. This information will be obtained from historical patient records. The expected number of events in this category was calculated using the following approach. 5 year endpoint, 10% event rate based on Conventional or hypofractionated high dose intensity modulated radiotherapy for prostate cancer (CHHIP) trial Data up to 2015 resulting in sample size of 11,250 (75% of 15,000) Total Events = 1125

  Plus/minus 10 years from date of radiotherapy treatment

• Overall Survival

  Overall survival will be measured from the date of treatment. This information will be obtained from historical patient records. The expected number of events in this category was calculated using the following approach. 10 year endpoint, 29% event rate based on RT01 radiotherapy trial Data up to 2010 resulting in sample size of 7,500 (50% of 15,000) Total Events = 2175

  Plus/minus 10 years from date of radiotherapy treatment

• Radiotherapy Toxicity

  Radiotherapy Toxicity was estimated based on the cohort toxicity reported in the CHHIP trial. The same estimates were applied to this cohort with the expected number of events as follows. Note that a higher attrition rate is expected for this endpoint, 60% of 15,000=10,000 5 year endpoint, 12% event rate for Grade 2+ toxicity based on CHHIP trial Total Events = 900

  Plus/minus 10 years from date of radiotherapy treatment

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study requires no new data to be acquired relying solely on data collected on previously treated prostate cancer patients.

You may qualify if:

• External beam radiotherapy delivered by a linear accelerator
• Prostate Specific Antigen (PSA) recorded at regular intervals after radiotherapy
• Minimum of 10 year survival post-radiotherapy
• Diagnostic Computerised Tomography (CT) acquired
• Radiotherapy planning CT acquired
• Radiotherapy treatment planning data available
• Corresponding healthcare data available to infer toxicity events (ref previous work by Lemanska et al)

You may not qualify if:

• Incomplete course of radiotherapy
• No PSA data
• No follow-up corresponding healthcare data available
• No imaging data available

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Greater Glasgow and Clyde: collaborator
• NHS Grampian: collaborator
• NHS Highland: collaborator
• NHS Tayside: collaborator
• University of Glasgow: collaborator
• University of Lyon: collaborator
• NHS Lothian: collaborator
• NHS Research Scotland: collaborator
• Public Health Scotland: collaborator
• Prostate Cancer UK: collaborator
• Movember Foundation: collaborator

Study Sites (1)

University of Edinburgh

Edinburgh, Lothian, EH4 2XU, United Kingdom

RECRUITING

Related Publications (1)

• Nailon WH, Noble DJ, Harrison E, Yang Z, Elliot S, MacNair A, Beckett G, Hallam A, Sheikh A, Mills N, Halliday R, Morrison D, Chalmers A, Cameron D, Gourley C, Hall P, Lilley C, Carruthers LJ, Trainer M, Burns D, Dee F, Andiappa S, Lonsdale A, Couper M, Farnan K, McLellan J, Miller A, Ogg J, Moses J, Colligan S, MacDonald G, McPhail N, Niblock P, MacLeod N, Davies ME, Laurenson DI, Hopgood JR, Boyle D, Paterson C, Grose D, Phillips I, Harrow S, Berger T, Shelley LEA, Sanders I, Henderson S, Duffton A, Mitchell J, Rutherford A, McLaren DB. Protocol for the PROSECCA study: a new approach for predicting radiotherapy outcome using artificial intelligence and electronic population-based healthcare data. BMJ Open. 2026 Feb 2;16(2):e104408. doi: 10.1136/bmjopen-2025-104408.

  PMID: 41628931 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

Study Officials

• Bill Nailon

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

• Duncan McLaren

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bill Nailon

CONTACT

0044 1315371000; w.nailon@ed.ac.uk

Duncan McLaren

CONTACT

0044 1316518706; Duncan.McLaren@ed.ac.uk

Study Design

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

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: December 3, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

GB (1)