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NCT04425200: ZENSHIN
Prevalence of HRR-related Genes Mutations and Prognosis in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients in Real World Setting
trial in Prostatic Neoplasms in 205 participants. Completed in 18 December 2020.
18 December 2020
Quick facts
| Lead sponsor | AstraZeneca |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 205 |
| Start date | 29 July 2020 |
| Primary completion | 18 December 2020 |
| Estimated completion | 18 December 2020 |
| Sites | 26 locations across Japan |
Conditions studied
- Prostatic Neoplasms — all drugs for Prostatic Neoplasms →
Sponsor
AstraZeneca — full company profile →
Who can join
Eligibility, male only, with Prostatic Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to investigate the prevalence of tissue homologous recombination repair (HRR)-related gene mutations (positive/negative/Variant of uncertain significance (VUS)), clinical outcome such as prostate-specific antigen-progression free survival (PSA-PFS), overall survivals (OS) and treatment pattern in mCRPC patients. \<Methods\> Study design: multi-center, prospective cohort study Data Source(s): In this study, 155 patients (expected recruitment patients: maximum 205 patients) will be enrolled from approximately 20\~30 sites in Japan. Study Population: mCRPC patients who diagnosed between 2014 and 2018. Exposure(s): N.A Outcome(s): Prevalence of tissue HRR-related gene mutations, clinical outcomes such as Over survival and PSA-PFS, Treatment pattern Sample Size Estimations: The target population is 155 patients based on the prevalence of HRR-related genes (BRCA1, BRCA2 and ATM) which is reported in previous global study (PROfound study). Statistical Analysis: This study is not intended to verify specific hypotheses, and the results are evaluated descriptively. There is no plan of interim analyses before the final analysis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04425200
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04425200 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
- Last refreshed: 7 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04425200.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing