PROCARE - PROstate Cancer Real World Evidence Registry

About This Trial

This study tracks health information over time to learn how prostate cancer progresses and how everyday treatments work in the real world.
It is open to adults whose prostate cancer has returned after previous treatments or has spread to other parts of the body, and who are starting a new treatment.
Because this is an observational study rather than a test of an experimental drug, you will continue to receive the standard care chosen by you and your doctor.
Before taking part, you should know that joining does not change your treatment and mainly involves allowing researchers to follow your health journey and collect data from your routine medical visits.

The aim of this registry study with long-term follow-up is to record the course of therapy and disease in patients with recurrent and metastatic prostate cancer.
The following patient groups are planned: - Patients with a recurrence of PSA after surgical removal or radiation of the prostate due to prostate cancer; so-called PSA recurrence (relapse) or biochemical recurrence. - Patients with a PSA recurrence who have received treatment by hormone deprivation therapy (so-called androgen deprivation) and in whom the PSA value has nevertheless risen again without spreading to other organs or parts of the body, so-called non-metastatic castration-resistant prostate cancer. - Patients with proven spread to other organs or parts of the body (= metastases, e.g. in the bone) without hormone deprivation therapy having been initiated, so-called metastatic hormone-sensitive prostate cancer. - Patients with prostate cancer and spread to other organs or parts of the body (= metastases) in whom the tumor disease has progressed despite hormone withdrawal treatment (e.g. as evidenced by an increase in PSA), so-called metastatic castration-refractory prostate cancer.
These four groups of patients are enrolled and observed independently of each other at different time periods.

Age Range: 18 years and older
Gender: Male
Who This Trial is For: This study tracks health information over time to learn how prostate cancer progresses and how everyday treatments work in the real world.

Full Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Patients who are not eligible for observation due to severe comorbidities or

unavailability according to the treating physician