PROCARE - PROstate Cancer Real World Evidence Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorUroTrials Company (GmbH)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

Adult prostate cancer patients (age ≥18 years) who will receive a new line of systemic therapy at the time of study entry or up to 4 weeks thereafter.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

5,000 Participants
are grouped into 4 trial groups
Group A: Cohort 1: biochemical recurrence (BCR) after local curative intended treatment
Group B: Cohort 2: non-metastatic castration-resistant prostate cancer (nmCRPC)
Group C: Cohort 3: metastatic hormone-sensitive prostate cancer (mHSPC)
Group D: Cohort 4: metastatic castration-resistant prostate cancer (mCRCP)

Trial outcomes

Primary outcomes

1

Therapy Frequencies and Patterns of Therapy

Description of therapy frequencies and patterns in routine clinical practice for the included patient cohorts

Time frame
Through study completion, an average of 7 years

Secondary outcomes

1

Annual (vs. cumulative) Patterns of Disease Management

Description of annual (vs. cumulative) patterns of disease management i.e. choice of treatment applied in German routine practice (including initial disease/ metastatic diagnosis and previous cancer drug and non-drug treatments)

Time frame
Through study completion, an average of 7 years
2

Methodology for Disease Status Assessment

Methodology used for disease status assessment (e.g. PSA-measurements, imaging)

Time frame
Through study completion, an average of 7 years
3

Frequency for Disease Status Assessment

Frequency for disease status assessment (e.g. PSA-measurements, imaging)

Time frame
Through study completion, an average of 7 years
4

Drug Effectiveness Depending on Prior Treatment

Assessment of drug effectiveness depending on prior use of an ARPI, docetaxel and other drugs in the BCR, nmCRPC and mHSPC setting as well as prior treatments for mCRPC

Time frame
Through study completion, an average of 7 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

UroTrials Company (GmbH)

Lead sponsor

Novartis Pharmaceuticals

Collaborator

AstraZeneca

Collaborator