PROSPECT
Prevalence of Homologous Recombination Repair (HRR) Gene Mutations in Patients With Metastatic Castration-resistant Prostate Cancer in Latin America: PROSPECT Study.
Sponsor study identifier
observational
388
7 countries
11
Study Start
April 21, 2021
Actual (reported)Primary Completion
April 8, 2022
Actual (reported)Study Completion
April 8, 2022
Actual (reported)Determine the prevalence of homologous recombination repair (HRR) gene mutations in participants with mCRPC in Latin America (LatAm) between February 2021 and January 2022.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 8, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 21, 2021
Actual (reported)June 17, 2021
Actual (reported)July 15, 2021
Actual (reported)April 8, 2022
Actual (reported)April 8, 2022
Actual (reported)Primary Outcome
To know the prevalence and type of Homologous Recombinational Repair (HRR) mutations identified in Formalin-fixed paraffin-embedded (FFPE) tissue or blood samples in patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC) in the selected participants countries in LatAm. A molecular test formulary would be completed when tissue sample is analyzed * Preservation time (years) * Origin of the FFPE (organ) * HRR mutation status (32 mutations would be analyzed and each of them would have as an answer "positive"/"negative"/"VUS") A molecular test formulary would be completed when blood sample is analyzed * Date of extraction (date) * HRR mutation status (32 mutations would be analyzed and each of them would have as an answer "positive"/"negative"/"VUS")
Q1 2021 - Q1 2022
Exploratory Outcomes
Q1 2021 - Q1 2022
Study population will be the diagnosed castration-resistant metastatic prostate cancer patients in the selected countries
Research Site
Buenos Aires, Argentina
Research Site
Rosario, Argentina
Research Site
Porto Alegre, Brazil
Research Site
Rio de Janeiro, Brazil
Research Site
São Paulo, Brazil
Research Site
Bogotá, Colombia
Research Site
San José, Costa Rica
Research Site
Archived FFPE tumor blocks (tissue sample) from eligible participants will be requested from the local pathology laboratory and used for HRR mutation testing. A blood sample will be taken from each participant enrolled in the study independently of the FFPE availability. Blood sample must be available for testing under the algorithm of this protocol. After checking FFPE tissue availability Pathologist will perform an assessment in order to check sample quality. If pathology assessment of FFPE sample accomplishes sample quality requirements tissue will be cut in 5um slices and 15 to 20 slides will be provided to reference laboratory.
Gabriel Garbaos, MD
Fundación Estudios Clinicos
Martin Angel, MD
INSTITUTO ALEXANDER FLEMING
Ray Manneh Kopp, MD
Sociedad de Oncología y Hematología del Cesar S.A.S.
Jorge A Chaves Porras, MD
Instituto de Investigaciones en Ciencias Médicas (ICIMED)
388 participants (actual enrollment reported by the registry).
First Submitted
June 17, 2021
First Posted
July 15, 2021
Study Start
April 21, 2021
Actual (reported)Contact the study team to confirm eligibility.
Mexico City, Mexico DF, Mexico
Research Site
Mexico City, Mexico
Research Site
Panama City, Panama
Research Site
Lima, Peru
Alejandro Crismatt, MD
Centro Hemato Oncológico Panamá (CHOP)
Silvia Neciosup, MD
Centro de Investigación Oncosalud - RCI N° 166
Miguel A Álvarez Avitia, MD
Instituto Nacional de Cancerología (INCAN)
Arturo Delgado Herrera, MD
Centro Médico Nacional Siglo XXI (CMNSXXI)
Pedro H Isaacsson Velho, MD
Centro de Pesquisa Hospital Moinhos de Vento
Primary Completion
April 8, 2022
Actual (reported)Study Completion
April 8, 2022
Actual (reported)Last Updated
April 14, 2023
Record last verified: 2023-04
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Source: ClinicalTrials.gov.
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