Clinical trial NCT06457854: Real-life Experience in Brazil in Patients With Castration-resistant Prostate Cancer Treated With Olaparib+Abiraterone
Official title: Real-life Experience in Brazil in Patients With Castration-resistant Prostate Cancer Treated With Olaparib+Abiraterone Observational Study Assessing Real World Clinical Endpoints and Demographic Characteristics in Patients With Castration-resistant Prostate Cancer Treated With Olaparib+Abiraterone
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostatic Neoplasms
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-06-13
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Mens with documented histology or cytology of PCa and adenocarcinoma and Documented as mCRPC. This population needs to be 18 years or older. The treatment with Olaparib+abiraterone needs to start after the activation of the research site.

Brief summary: PROCeed is an observational study assessing real world clinical endpoints and demographic characteristics in patients with castration-resistant prostate cancer treated with Olaparib+Abiraterone.

Detailed description: PROCeed is an observational, longitudinal study with prospective data from Brazilian participating sites, so as to generate real-world data. 10 Brazilian oncology sites are estimated to participate in the study. Each site will have participating investigators in charge and a proper technical team who will be in charge of data from each service. For this study, a convenience sample will be adopted, with an expected 2-year recruitment of 80 patients. The protocol was created in Germany and other countries could use it, with the potential for data from other countries to be pooled for analysis.

Recruitment to each subgroup will be monitored every 3 months and feasibility for continued enrolment will be assessed after 1 year of recruitment (at months 3 and 6, recruitment will be evaluated for proper site selection); if \<20 patients have only been enrolled in a particular subgroup after 1 year, the study team will assess feasibility of pooling data from other countries to allow for at least 40 patients in a pooled analysis for that subgroup.

The study plans to recruit patients for no more than 2 years and to follow patients from the start of olaparib to 1 year after last patient inclusion (LPI). Data will be collected from the medical record through an electronic case report form (eCRF). Participating physicians will be responsible for ensuring that all necessary data are collected and entered in the eCRF. Data compilation will be performed by the principal investigator and statistical analysis will be performed by the statistics team appointed by the Academic Research Organization (ARO).

The target sample size of 80 patients in Brazil is based in a 24-month recruitment period. In order to avoid unnecessary imprecision for the subgroup previously exposed to a new hormonal agent, a minimum enrolment of 50% (40 patients) of the total sample size will be imposed for this subgroup. Estimation is determined based on the primary objective of the TTD event-free rate; the main measure of interest is at 6 months for patients previously exposed to NHA and 12 months for patients naïve to NHA. Assuming a 6- month TTD event-free rate is of approximately 50% for patients previously exposed to new hormonal agent, with a sample size of 40 patients in this subgroup, the precision would be +/- 15,5%.

Eligibility criteria: Inclusion Criteria:

1. Willing to provide written informed consent;
2. 18 years or older;
3. Documented histology or cytology of PCa, adenocarcinoma;
4. Documented as mCRPC;
5. Olaparib+abiraterone started after the activation of the research site.

Exclusion Criteria:

Patients participating in a clinical trial with investigational treatment for prostate cancer within 30 days before starting olaparib.

Primary outcomes:
measure: To evaluate the real-world effectiveness, measured by Time to treatment discontinuation or death, of olaparib+abiraterone in 1L Castration-resistant prostate cancer
timeFrame: May 2026
Secondary outcomes:
measure: Describe the demographic and clinical characteristics of Castration-resistant prostate cancer patients treated with olaparib+abiraterone in the general population and also in each population.
timeFrame: May 2026
measure: Describe the treatments received before and after olaparib+abiraterone in general population and also in each population.
timeFrame: May 2026
measure: To evaluate Time to first subsequent therapy or death in patients with Castration-resistant prostate cancer treated with olaparib+abiraterone in general population and also in each population.
timeFrame: May 2026
measure: To describe the demographic data, clinical characteristics, previous and subsequent treatments of patients with mCRPC treated with olaparib+abiraterone in overall cohort and in subgroups 1 and 2, additionally stratified by BRCA/HRR mutation status.
timeFrame: May 2026
Other outcomes:
measure: To evaluate the real world effectiveness, measured by Time to treatment discontinuation or death, of olaparib+abiraterone in 1L mCRPC
timeFrame: May 2026
measure: To evaluate additional clinical outcomes (OS, rwPFS) in general population and also in each population
timeFrame: May 2026
measure: Describe the dosage in patients treated with the combination of olaparib+abiraterone in general population and also in each population
timeFrame: May 2026
measure: Describe the reasons for dose change/discontinuation in patients treated with the combination of Olaparib+Abiraterone in general population and also in each population
timeFrame: May 2026
measure: To evaluate the PSA25 and PSA50 response with an evaluation tool to predict the practical clinical activity in the real world.
timeFrame: May 2026
measure: To evaluate the time to progression of PSA.
timeFrame: May 2026
Locations:
city: Salvador
country: Brazil
facility: Clínica AMO
state: Bahia
city: Natal
country: Brazil
facility: Liga Norte Rio Grandense Contra o Câncer
state: Rio Grande Do Norte
city: Santa Maria
country: Brazil
facility: Clínica Viver
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: Hospital Alemão Oswaldo Cruz
city: São Paulo
country: Brazil
facility: Hospital Albert Einstein
Study officials:
affiliation: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein Centro de Ensino e Pesquisa Albert Einstein
name: Henrique Helber
role: STUDY_CHAIR
References: