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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05701007
Other study ID # C3441057
Secondary ID PrCa-RWD
Status Completed
Phase
First received
Last updated
Start date February 13, 2023
Est. completion date April 10, 2024

Study information

Verified date April 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Comprehensive understanding of the epidemiology and disease burden of metastatic prostate cancer patients in Finland is lacking. This study will address the following questions: - What are the demographic and clinical characteristics of metastatic prostate cancer patients? - How are metastatic prostate cancer patients currently treated and how effective are these treatments? - How does the development of castration-resistance affect patient outcomes? - What is the economic burden of metastatic prostate cancer?


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date April 10, 2024
Est. primary completion date April 10, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of prostate cancer between 1/1/2007 - 12/31/2022 - Resident of Pirkanmaa at index date (diagnosis of mCSPC and/or mCRPC) - Detection of metastatic prostate cancer Exclusion Criteria: - Prevalent mCSPC and mCRPC patients (mCSPC or mCRPC diagnosis date before 1/1/2014 - Patient has another cancer diagnosis or the patient has received chemotherapy other than docetaxel or cabazitaxel within 2 years of mPC diagnosis.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
abiraterone
mCRPC
enzalutamide
mCRPC
docetaxel
mCRPC
apalutamide
mCRPC
cabazitaxel
mCRPC
Radium-223
mCRPC
Lutetium-177
mCRPC
degarelix
mCSPC
goserelin
mCSPC
leuprorelin
mCSPC
triptorelin
mCSPC

Locations

Country Name City State
Finland Pfizer Helsinki

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Characteristics of Metastatic Cancer Patients Demographical and clinical variables of patients will be summarized up to 12 years
Primary Number of treatments received for metastatic prostate cancer up to 12 years
Primary Overall Survival (OS) up to 12 years
Primary Time to next treatment (TTNT) up to 12 years
Secondary Time of disease progression from castration sensitive to castration resistant up to 12 years
Secondary Identify factors associated with disease progression to castration resistant Up to 12 years
Secondary The number of patients per treatment type up to 12 years
Secondary Incidence of metastatic prostate cancer (mPC) Up to 12 years
Secondary Incidence of metastatic castration sensitive prostate cancer (mCSPC) up to 12 years
Secondary Incidence of metastatic castration resistant prostate cancer (mCRPC) up to 12 years
Secondary Health Care resource utilization (HCRU): number of outpatient clinic visits, hospitalization and hospital inpatient days up to 12 years
See also
  Status Clinical Trial Phase
Terminated NCT05208229 - The Role of WB-MRI in the Evaluation of Prostate Cancer Patients Treated With Lutetium - Prostate Specific Membrane Antigen (Lu-PSMA)
Suspended NCT05425862 - Pidnarulex and Talazoparib in Patients With Metastatic Castration Resistant Prostate Cancer Phase 1
Active, not recruiting NCT03480646 - ProSTAR: A Study Evaluating CPI-1205 in Patients With Metastatic Castration Resistant Prostate Cancer Phase 1/Phase 2
Recruiting NCT03874884 - 177Lu-PSMA-617 Therapy and Olaparib in Patients With Metastatic Castration Resistant Prostate Cancer Phase 1
Terminated NCT03549000 - A Phase I/Ib Study of NZV930 Alone and in Combination With PDR001 and /or NIR178 in Patients With Advanced Malignancies. Phase 1
Terminated NCT04052204 - Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03724747 - Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Antitumor Activity of a Thorium-227 Labeled Antibody-chelator Conjugate Alone and in Combination With Darolutamide, in Patients With Metastatic Castration Resistant Prostate Cancer Phase 1
Completed NCT04516161 - EPIX, a Study to Gather More Information About Characteristics of Patients and Other Factors Which May Contribute to Survival Over a Long Period of Time in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Treated With Radium-223 (Xofigo)
Withdrawn NCT02130947 - Exercise Intervention for Pts With Metastatic Castration-Resistant Prostate Cancer Receiving Abiraterone or Enzalutamide N/A