PROceedRecruiting

Observational Study on the Treatment of Metastatic, Castration-Resistant Prostate Cancer with Olaparib + Abiraterone

Gender
Women and men
Age
18 years and older
Trial type
Observational
Line of therapy
all
Phase

What is this trial about?

The combination of olaparib and abiraterone is an already approved treatment option for patients with metastatic castration-resistant prostate cancer (mCRPC) when chemotherapy is not clinically indicated. The goal of the PROceed study is to collect additional data on treatment with the combination therapy of olaparib plus abiraterone in routine clinical practice. Men aged 18 and older with metastatic, castration-resistant prostate cancer are eligible to participate in this study.

Trial flow

Requirements

Diagnosis: Prostate cancer

Age: 18 years and older

Line of therapy: Unabhängig von Therapielinie

Key inclusion criteria: Metastatic; castration-resistant; ongoing treatment with olaparib + abiraterone

Allocation

Einarmige Studie

Treatment

RegistryCollection of treatment data in routine clinical care

Follow-up

24 months

Detailed description

Prostate cancer is a malignant tumor of the prostate characterized by the uncontrolled, malignant proliferation of prostate tissue. In its early stages, the disease is usually asymptomatic; in advanced stages, symptoms may include frequent or difficult urination, blood in the urine or semen, and pain in the pelvis or lower back. The cancer can also form metastases (distant spread of cancer cells to other organs). Various treatment strategies are available, which are selected based on the patient and the characteristics of the tumor. In many cases, the goal of primary treatment is to lower testosterone levels (hormone deprivation therapy), since prostate cancer cells generally grow in response to the hormone testosterone. Either surgical removal of the testicles or hormonal therapy is suitable for this purpose. If tumor growth is observed despite the reduction in testosterone levels, the cancer is referred to as castration-resistant prostate cancer. For adult patients with metastatic, castration-resistant prostate cancer who are not suitable candidates for chemotherapy, the combination therapy of olaparib plus abiraterone has already been approved. Olaparib is a poly-ADP-ribose polymerase (PARP) inhibitor that prevents the repair of DNA damage in cancer cells, leading to cancer cell death. Abiraterone is used as part of antihormonal therapy and inhibits the production of testosterone, thereby removing the stimulus for cancer cell growth.

The goal of this observational study is to collect treatment data on the combination therapy of olaparib plus abiraterone in the clinical care of patients. No new form of therapy is being investigated.

Men aged 18 and older with metastatic, castration-resistant prostate cancer are eligible to participate in this study.

Facts

  1. What condition: Prostate cancer (mCRPC).
  2. Cancer characteristics: metastatic, castration-resistant, ongoing treatment with olaparib + abiraterone.
  3. What the study investigates: olaparib + abiraterone in routine clinical care.
  4. Study objective: Collection of treatment data.
  5. How long will the study last: up to approximately 2 years.
  6. Study characteristics: Observational study; no new form of therapy is being investigated.

Trial sites

5 trial sites in Germany are listed.

  • Medizinische Hochschule Hannover

    30625

    Recruiting
  • Universitätsklinikum Augsburg

    86156

    Recruiting
  • Universitätsklinikum Frankfurt

    60590

    Recruiting
  • Universitätsklinikum Gießen und Marburg GmbH, Standort Marburg

    35043

    Recruiting
  • Universitätsklinikum Tübingen

    72076

    Recruiting

This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.

Medical editorial team

  • Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
  • PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine

This description is based on the public trial registry (NCT06380738) and was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.