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Overview of existing
ICECaP projects

The list of ICECaP collaborators can be found here.

ICECaP Adjuvant

Dana-Farber Co-ordinating Center

  • Christopher Sweeney
  • Wanling Xie
  • Meredith Regan
  • Lucia Kwak
  • Praful Ravi
  • Jiaming Huang

Process &

Creation of a repository of individual patient data from intermediate and high-risk localized prostate cancer trials will enable:

  • Credentialing earlier clinical endpoints as surrogates for overall survival and clinical benefit to expedite clinical trial conduct
  • Identify which patients benefit from a given therapy

April 2021

  • Metastasis-free survival (MFS) has been credentialed as a strong surrogate for overall survival and adopted as a primary endpoint for large phase 3 international and national academic and pharmaceutical sponsored trials in all regions of the world
  • Documented Prostate-Specific Antigen (PSA) based endpoints are very weak surrogates for overall survival and currently exploring different parameters to determine the definition with the strongest association with MFS and prostate cancer-specific survival
  • Data collection is ongoing from trials instituted in era of therapies with life-prolonging therapies for metastatic prostate cancer


Centre for Health Economics Research and Evaluation; University of Technology Sydney

  • Richard De Abreu Lourenco
  • Rafael de Feria Cardet
  • Tracey Laba 
  • Stephen Goodall
  • Marion Haas

Advisory Committee

  • Ian Davis
  • Scott Williams
  • Christopher Sweeney
  • Ray Allen (Consumer Advisory Panel rep)
  • Lisa Horvath
  • Margaret McJannett

Government and Industry
Advisory Committee

  • Kirsten Howard
  • Jennifer Houltram
  • Preet Chadha
  • Brandon Jones

Process &

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

  • 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

Harmonization of clinical trial conduct

Steering committee

  • Anis Hamid
  • Silke Gillessen
  • Wendy Parelukar
  • Srikala Sridhar
  • Christopher Sweeney

Process &

Scrutinize completed and ongoing protocols to identify alignment and variation of clinical trial conduct with the goal of defining a harmonized approach for eligibility, endpoint ascertainment and other relevant items for trial conduct and data harmonization for future individual patient data analyses.

April 2021

  • Protocols for adjuvant trials have been scrutinized and a multi-disciplinary working group has been convened to develop guidelines. A draft manuscript is being reviewed by the working group
  • Discussions ongoing for value and timing for writing a document for harmonization of clinical trial conduct for metastatic hormone-sensitive prostate cancer guided by the findings from the individual patient data collection by the STOPCAP effort


MRC Clinical Trials Unit
at UCL (Efficacy reviews)

  • Jayne Tierney
  • Sarah Burdett
  • Claire Vale
  • Larysa Rydzewska
  • Ewelina Rogozinska
  • David Fisher
  • Peter Godolphin
  • Max Parmar

Duke University (surrogacy/prognosis)

  • Susan Halabi
  • Akash Roy
  • Larysa Rydzewska
  • Christopher Sweeney

Process &

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.


April 2021

  • 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.


Working Group Co-leads

  • Gerhart Attard
  • Christopher Sweeney
  • Felix Feng

Process &

Assembly of a repository of an individual patient clinical, imaging, and biological data (RNA, DNA, epigenetic, histology, bloodborne markers) from men enrolled onto clinical trials assessing treatments for high-risk localized or metastatic hormone-sensitive prostate cancer. This valuable resource will enable robust biomarker development to define the right treatment for the right patient at the right time.

April 2021

  • Samples and data have been collected from men with M1HSPC from STAMPEDE-ADT, docetaxel, abiraterone; CHAARTED; ENZAMET, PEACE-1
  • Samples and data have been collected from men with high-risk adjuvant localized prostate cancer: STAMPEDE-ADT, docetaxel, abiraterone; NRG/RTOG0521 9601; ENZARAD

To suggest a project for ICECaP

Send a project synopsis to 
icecap@movember.com for review by the Steering Committee.

Process for Sending Project Proposals

In accordance with ICECaP charter for ensuring appropriate governance of the individual patient data. Following steps will be required:

  • Step 1: Send one-page synopsis for steering committee review
  • Step 2: Steering committee will review for scientific value and assess for adherence to ICECaP charter and feasibility.

If approved, one of two processes can be considered.

Process 1:
Transfer of data to an outside research team

  • Obtain approval from each trial executive committee for use of data*
  • Local IRB approval for secondary use of the data for a given project
  • DFCI biostatisticians transfer de-identified harmonized data

Process 2:
Analysis by Dana-Farber Co-ordinating Center

  • Determine bandwidth/effort of DFCI team to perform the analysis and approval from the steering committee
  • Obtain approval from each trial executive committee for use of data*
  • DFCI biostatics core will develop a timeline for performing the analysis

*Determine if letters of approval from trail executive committee or independent DUA are needed; Establish authorship / publication strategy