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Information sheet on the clinical trial - PROceed

Main indication

 Prostate cancer

 

Study name (study type)

PROceed - prospective observational study

 

Study sponsor

AstraZeneca

 

Registration number

Study Code D0817R00074

 

FOR SKIMMERS:

This is a prospective, non-interventional study to investigate the clinical data and characteristics of patients with metastatic castration-resistant prostate cancer who are being treated with olaparib + abiraterone in real-world settings in Germany. 

 

DETAILED INFORMATION

PROceed aims to describe the practical application and clinical experience in treating
patients with metastatic castration-resistant prostate cancer (mCRPC) using the combination of olaparib and abiraterone in the mCRPC setting. 

Study Title

PROceed - prospective, non-interventional study to investigate the clinical data and characteristics of patients with metastatic, castration-resistant prostate cancer

 

Which conditions are being treated in the study?

Prostate cancer

 

Are specific subgroups of patients with one of the mentioned conditions being treated?

Metastatic, castration-resistant prostate cancer

 

Background on the study medication

None

 

Study Protocol.

The study plans to enroll patients for a maximum of 2 years and to
follow up on patients from the start of treatment with olaparib until 1 year after the last patient is
enrolled (LPI). Data will be collected from medical records via an electronic case report form
(eCRF). Participating physicians are responsible for ensuring that
all required data is collected and entered into the eCRF

 

Inclusion Criteria

  • Patients who are willing and able to provide written informed consent
  • Patients who are at least 18 years of age
  • Patients with metastatic, castration-resistant prostate cancer (documented histopathologically or cytopathologically)
  • Patients who have started treatment with olaparib + aviraterone after the center was activated

 

Exclusion criteria

  • Patients who, within 30 days prior to the start of treatment with olaparib, are participating in
    a clinical trial of
    an investigational prostate cancer treatment.

 

Your contacts: Investigators at the center and contact information

Dr. Guido Platz

Email: platz@gp-ruesselsheim.de

 

Staff members responsible at the study clinic

Heike Borchert (Study Coordinator)

Email: borchert@~@gp-ruesselsheim.de

Phone: 06142 88-1032

Clinical studies and medical documentation