NCT06835218 PROCARE - PROstate Cancer Real World Evidence Registry
| NCT ID | NCT06835218 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UroTrials Company (GmbH) |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2024-01-29 |
| Primary Completion | 2031-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2024-01-29 with a primary completion date of 2031-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Marc-Oliver Grimm, Professor
STUDY DIRECTOR
University Hospital Jena
Frequently Asked Questions
Who can join the NCT06835218 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06835218 currently recruiting?
Yes, NCT06835218 is actively recruiting participants. Contact the research team at andrea.roessler@urotrials.de for enrollment information.
Where is the NCT06835218 trial being conducted?
This trial is being conducted at Freiburg im Breisgau, Germany, Heidelberg, Germany, Mannheim, Germany, Nürtingen, Germany and 11 additional locations.
Who is sponsoring the NCT06835218 clinical trial?
NCT06835218 is sponsored by UroTrials Company (GmbH). The principal investigator is Marc-Oliver Grimm, Professor at University Hospital Jena. The trial plans to enroll 5,000 participants.
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