Process &
Goal

Develop a model using ICECaP individual patient data and published quality of life data that accurately reflects the “clinical states” of no relapse versus relapse with an array of potential cascading events.

April 2021
Status

• Model is in advanced stage of development and designed to estimate the value of treatments for prostate cancer, capturing the patient and societal benefits from preventing a relapse
• Model has been designed to be flexible across treatments/ settings and can be utilized for defining clinical benefits and financial benefit as independent outputs
• One specific project under development is to define the quality-adjusted life years (QALY) gained / lack of disability life years (DALY) associated with decrease PSA relapse

Process &
Goal

Speed up and improve the evaluation of therapies for metastatic, hormone-sensitive prostate through:

• STOPCAP M1 efficacy: Systematic reviews and meta-analysis of aggregate data for the timeliness, and of individual participant data (IPD) for in-depth investigation of which treatments are most effective for whom.
• STOPCAP M1 surrogacy: Developing prognostic models and validating earlier clinical endpoints as surrogates for overall survival and clinical benefit to expedite clinical trial conduct.
• STOPCAP M1 Repository: Establishing a repository of IPD as a resource for tackling new questions about advanced prostate cancer and its treatment as they arise.

http://www.stopcapm1.org/

April 2021
Status

• Using our new prospective FAME approach to meta-analysis, we showed that adding abiraterone to standard care improves 3-year overall survival and progression-free survival. Although it increases some serious side effects, it is not associated with an excess of deaths.
• A network meta-analysis demonstrated that abiraterone plus standard care has the highest probability of being the most effective treatment for metastatic hormone-sensitive prostate cancer, followed by docetaxel plus standard care.
• Another FAME meta-analysis has shown that the benefits of prostate radiotherapy on 3-year overall survival and progression-free survival are confined to men with a low metastatic burden.
• Of 17 trials (12,569 patients) currently in scope for STOPCAP efficacy and surrogacy work, we have an agreement to provide IPD directly for 14 trials, and data use agreements are being prepared for the remaining 3 trials. We have data in-house for 9 trials (5455 patients), data from two others are due shortly, and we have access to data for a further 3 trials via repositories.
• Gained access to three trials from the NCI Data Archive (CALGB 90202, SWOG 9346, and CHAARTED) in addition received data 5 trials from the MRC STOPCAP M1 team for surrogacy and prognostic factor analyses.
• Harmonized clinical endpoints for all the individual patients from the eight mHSPC trials.
• Published two articles regarding imputing missing data for building a prognostic model of survival outcomes, and checking for residual in survival analysis.
• The team is also exploring the viability of developing a simple prognostic model with patients having “good vs intermediate vs poor” prognosis mHSPC to guide the evaluation of patients on trial and as well as biological studies.