The PROSECCA Study, Answering New Questions in Prostate Cancer
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
AgeNot listed
SponsorUniversity of Edinburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Incomplete course of radiotherapy
No PSA data
No follow-up corresponding healthcare data available
No imaging data available
Trial population
This study requires no new data to be acquired relying solely on data collected on previously treated prostate cancer patients.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
Plus/minus 10 years from date of radiotherapy treatment2
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
Time frame
Plus/minus 10 years from date of radiotherapy treatment3
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
Time frame
Plus/minus 10 years from date of radiotherapy treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Edinburgh
Lead sponsor
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
Source ClinicalTrials.gov