PROstate CAncer Real World Evidence Registry: RECURRENT AND METASTATIC PROSTATE CANCER
- Conditions
- C61Malignant neoplasm of prostate
- Registration Number
- DRKS00033411
- Lead Sponsor
- roTrials GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 5000
• Adult prostate cancer patients (age =18 years).
• Diagnosis at time of study inclusion
Cohort 1: biochemical recurrence (BCR) after local curative intended treatment (e.g. radical prostatectomy, radiotherapy of the prostate or combination thereof)
Cohort 2: non-metastatic castration-resistant prostate cancer (nmCRPC) or
Cohort 3: metastatic hormone sensitive prostate cancer (mHSPC) or
Cohort 4: metastatic castration-resistant prostate cancer (mCRPC) (irrespective of treatment choice, treatment line)
• Patients who will receive a new line of systemic therapy at the time of study entry or up to 4 weeks thereafter. Regarding Cohort 4 this includes patients with a new diagnosis of mCRPC (=first line mCRPC) after either treatment for mHSPC or non-metastatic CRPC as well as patients with prior mCRPC treatments (2nd, 3rd, … line).
• For Cohorts 1, 2 and 3: Disease proven by clinical measures (i.e. standard imaging) to be either unsuitable for local salvage treatment (e.g. surgery, radiotherapy) or local treatment is declined by the patient.
• Patients, who are able and willing to sign the informed consent form
Patients who are not eligible for observation due to severe comorbidities or unavailability according to the treating physician
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To describe therapy frequencies and patterns of therapy in routine clinical practice for the included patient cohorts
- Secondary Outcome Measures
Name Time Method