Prospective Multicentre Cohort Study PROREPAIR-B (mCRPC)

NCT03075735 | Completed

• 1 other identifier: CNIO-CP-2013-02-B
• Study Type: observational
• Target: 408
• Locations: 0 countries
• Sites: N/A

Brief Summary

PROREPAIR is a prospective multicenter observational cohort study of unselected patients with metastatic Castration Resistant Prostate Cancer (mCRPC) with unknown germline mutational status at study entry and who are candidates to start 1st line treatment with any approved survival-prolonging agent. The study aims to evaluate the impact of aberrations in DNA-repair genes,(BRCA1, BRCA2, ATM and PALB2 and other genes) on cause-specific survival from the diagnosis of the metastatic castration resistant status and other outcomes.

Conditions

Prostate Cancer

Keywords

Castration-Resistant Prostate Cancer; DNA-repair; BRCA1; BRCA2; ATM; PALB2

Outcome Measures

Primary Outcomes (1)

• Assessment of the impact of BRCA1, BRCA2, ATM, PALB2 germline mutations

  To assess the impact of BRCA1, BRCA2, ATM, PALB2 germline mutations on cause-specific survival from diagnosis of metastatic castration resistance status.

  42 months

Secondary Outcomes (6)

• Analysis of the impact of other germline mutations in other DNA repair genes

  42 months

• Correlation between DNA repair germline mutation carrier status and survival

  42 months

• Correlation between DNA repair germline mutation and biochemical response

  42 months

• Correlation between DNA repair germline mutation and radiographic response

  42 months

• Correlation between somatic DNA repair abnormalities with cause-specific survival

  42 months

Study Arms (1)

Metastatic castration resistant patients

The exposition to the primary analysis risk factor (germline deleterious mutation in BRCA1, BRCA2, ATM or PALB2 gene) will be determined after inclusion. Briefly, a NGS targeted-panel based on the majority of genes included in the BROCA panel and additional DNA-repair related genes has been designed based on the available technology. The pathogenicity of germline variants will be determined according to established American College of Medical Genetics and Genomics and Association for Molecular Pathology current consensus at the time of final primary outcome analyses. Variants will also be reviewed against published literature and public databases. According to their mutation-carrier status patients will be classified as: A) Mutation Carriers in BRCA1, BRCA2, ATM and PALB2 genes; B) Mutation carriers in other genes included in the BROCA panel; C) Mutation carriers in others DNA-repair genes D)Non-carriers

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Recently diagnosed castration resistant prostate cancer without known mutation carrier status at study entry

You may qualify if:

• Provision of signed informed consent.
• Patients must be ≥18 years old.
• Histologically confirmed prostate cancer
• presence of metastatic disease according to Bone-, CT- and/or MRI-scan.
• Confirmed castration resistant prostate cancer defined as disease progression despite castrate levels of testosterone (\<0.5ng/mL) and either a continuous rise in the serum prostate-specific antigen (PSA) levels, the progression of preexisting disease and /or the appearance of new metastases. Patients must be maintained on aLHRH or have underwent bilateral orchiectomy.
• Eligible patients are due to start or have started first-line treatment with any approved survival-prolonging therapy for mCRPC within a period of 6 months from study entry.
• ECOG performance status ≤21.
• Unknown mutation carrier status at the study entry.

You may not qualify if:

• Previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free or those diagnosed with skin cancers (of non-melanoma type) or excised in situ carcinomas.
• Any prior medical history that according to the judgement of the investigator might interfere with the subject´s granting of informed consent or the safe execution of the procedures required in the study.

Sponsors & Collaborators

• Centro Nacional de Investigaciones Oncologicas CARLOS III: lead
• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: collaborator
• Instituto de Investigacion Biomedica de Malaga: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, serum, archival FFPE and fresh tumour samples

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

• David Olmos, MD

  Centro Nacional de Investigaciones Oncologicas CARLOS III

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 9, 2017
• Study Start: January 15, 2013
• Primary Completion: May 1, 2018
• Study Completion: December 15, 2018
• Last Updated: February 4, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share