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Clinical Trials for Metastatic Prostate Cancer: Current Research and Treatment Options

There are currently 43 ongoing clinical trials studying new treatments for metastatic prostate cancer, a condition where prostate cancer has spread beyond the prostate gland to other parts of the body. These trials are testing various medications and treatment combinations across multiple countries in Europe, offering opportunities for patients whose cancer has spread or become resistant to standard hormone therapy. (Also known as: Advanced Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer, mCRPC, Metastatic Hormone-Sensitive Prostate Cancer, mHSPC)

Clinical trial locations

Study Comparing Docetaxel and Androgen Receptor-Targeted Agents (Abiraterone or Enzalutamide) for Patients with Metastatic Castration-Resistant Prostate Cancer

This trial, taking place in Italy, compares two treatment approaches for men with metastatic castration-resistant prostate cancer. One group receives docetaxel chemotherapy given through intravenous infusion, combined with prednisone. The other group receives either abiraterone or enzalutamide (both oral medications) along with prednisone.

Main inclusion criteria: Participants must be male adults aged 18 or older with confirmed prostate cancer that has spread beyond the prostate and continues to grow despite treatments that lower testosterone levels. They should have received at least 12 weeks of abiraterone treatment and show signs of disease progression. Participants must have adequate blood counts, liver function, and kidney function, and have a life expectancy of at least 6 months.

Main exclusion criteria: Patients with certain genetic mutations (BRCA1/2) or whose mutation status is unknown cannot participate. Only male patients are eligible. Vulnerable populations, such as those unable to provide informed consent, are excluded.

Trial focus and goals: The study aims to determine whether docetaxel is more effective than androgen receptor-targeted agents in treating patients without BRCA1/2 mutations. Researchers will measure how long patients live without their cancer worsening (progression-free survival) and compare overall survival rates between the two treatment groups. The study also assesses quality of life using standardized questionnaires.

Investigational drugs: Docetaxel is a chemotherapy drug that stops cancer cells from growing and dividing. Abiraterone lowers male hormone levels that can fuel cancer growth. Enzalutamide blocks the effects of male hormones on cancer cells. Prednisone is a steroid used to reduce inflammation and manage treatment side effects.

Study Comparing Ifinatamab Deruxtecan and Docetaxel for Patients with Advanced Prostate Cancer Resistant to Hormone Therapy

This trial, conducted across multiple countries including Germany, Denmark, Czechia, Sweden, and Austria, compares a new treatment called ifinatamib deruxtecan with docetaxel chemotherapy for men with metastatic castration-resistant prostate cancer.

Main inclusion criteria: Participants must be male, at least 18 years old, with confirmed prostate cancer (adenocarcinoma type without small cell features) that has spread to other parts of the body. The cancer must show progression while on hormone therapy or after surgical removal of testicles. Participants must have received treatment with 1 or 2 androgen receptor pathway inhibitors for at least 8 weeks, with the cancer continuing to progress. They need good physical function (ECOG score 0-1) and must provide tumor tissue samples.

Main exclusion criteria: Patients with other serious health conditions, those currently receiving other experimental treatments, patients with known allergies to the study drugs, uncontrolled heart conditions, severe liver or kidney problems, active infections, untreated brain metastases, other active cancers within the past 5 years, or those unable to take oral medications are excluded.

Trial focus and goals: The study evaluates whether ifinatamib deruxtecan can help patients live longer and slow cancer progression as seen on imaging scans. Researchers will monitor how long patients live, how long before their cancer worsens, response rates, and any side effects. The trial continues until disease progression, unacceptable side effects, or participant withdrawal.

Investigational drugs: Ifinatamib deruxtecan is an antibody-drug conjugate that targets specific proteins on cancer cells to deliver cancer-fighting drugs directly to them. Docetaxel is a well-established chemotherapy drug that damages cancer cell DNA to prevent growth and division.

Study of 177Lu-PSMA and Stereotactic Radiotherapy vs. Radiotherapy for Patients with Oligometastatic Prostate Cancer

This trial in Italy compares two treatment approaches for oligometastatic prostate cancer, where the cancer has spread to a limited number of other locations. One group receives Lu-PSMA combined with stereotactic radiotherapy, while the other receives radiotherapy alone.

Main inclusion criteria: Participants must be male adults between 18 years old or older with confirmed prostate cancer that has 1-3 metastatic lesions (no larger than 5 cm or 250 cubic centimeters) as shown by imaging scans. They must be receiving androgen deprivation therapy unless they’ve had surgical removal of testicles. Participants need good physical function (ECOG Performance Status of 2 or less), a life expectancy of at least 6 months, and adequate organ function including normal blood counts and liver/kidney function.

Main exclusion criteria: Only male patients can participate. Female patients and vulnerable populations (those unable to give informed consent) are excluded.

Trial focus and goals: The study aims to assess cancer progression and monitor progression-free survival over 12 months. Researchers will track PSA levels (a protein indicating prostate cancer activity), perform regular imaging scans, and evaluate quality of life using standardized questionnaires. The primary goal is to determine which treatment approach is more effective in preventing cancer progression.

Investigational drugs: Lu-PSMA is a targeted therapy that uses a radioactive substance to bind to prostate cancer cells and deliver radiation directly to them. Stereotactic radiotherapy delivers high-dose radiation precisely to small cancer areas with minimal impact on surrounding healthy tissue.

Study of AZD5305 with Abiraterone Acetate and Darolutamide in Men with Metastatic Castration-Sensitive Prostate Cancer

This large international trial across 11 European countries tests whether adding the experimental drug AZD5305 to standard hormone therapy can improve outcomes for men with newly diagnosed or recurring metastatic castration-sensitive prostate cancer.

Main inclusion criteria: Participants must be male, at least 18 years old, with confirmed prostate cancer that has spread to other parts of the body but still responds to hormone therapy. The cancer must be verified through imaging tests showing at least one bone lesion or soft tissue lesion. Participants must be receiving androgen deprivation therapy (ADT) with specific medications or have had surgical removal of both testicles. They need adequate organ function, good physical status (ECOG 0 or 1), and a life expectancy of at least 12 months.

Main exclusion criteria: Female patients, those not within the specified age range, and vulnerable populations are excluded.

Trial focus and goals: The study compares radiographic progression-free survival (time until cancer worsens on imaging tests) between patients receiving AZD5305 with hormone therapy versus hormone therapy alone. Researchers will also monitor overall survival, time to developing castration-resistant disease, and quality of life. Regular imaging tests and blood samples will track treatment effectiveness.

Investigational drugs: AZD5305 is an experimental drug being tested in combination with new hormonal agents. Abiraterone acetate, darolutamide, and enzalutamide are hormone therapies that work by blocking male hormone production or effects to slow cancer growth.

Study of Darolutamide and Testosterone for Patients with Advanced Prostate Cancer Resistant to Standard Hormone Therapy

This German trial examines a novel approach combining darolutamide (which blocks male hormones) with bipolar androgen therapy (which alternates between high and low testosterone levels) for men with metastatic castration-resistant prostate cancer.

Main inclusion criteria: Participants must be male, at least 18 years old, with confirmed prostate cancer that has spread and continues to grow despite hormone-lowering treatments. They must have a PSA level of 1.0 ng/mL or higher and be receiving continuous hormone therapy with testosterone levels below 50 ng/dL. The cancer must have progressed while on specific medications (Apalutamide, Darolutamide, or Enzalutamide), shown by either rising PSA levels or tumor growth on scans. Participants need adequate kidney, liver, and blood cell function, and good physical status (ECOG 0-2).

Main exclusion criteria: Patients with allergies to study drugs, serious heart problems (including recent heart attack, unstable chest pain, or heart failure), history of seizures, severe liver or kidney problems, those taking certain interacting medications, recent chemotherapy recipients, those with other serious medical conditions, or those unable to follow study procedures are excluded.

Trial focus and goals: The study tests whether combining darolutamide with bipolar androgen therapy can improve progression-free survival and quality of life compared to standard care. Treatment continues until disease progression, significant side effects, or the study ends in December 2027. Researchers will monitor PSA levels, perform imaging scans, track side effects, and assess quality of life using standardized questionnaires.

Investigational drugs: Darolutamide blocks male hormone effects that stimulate cancer growth. Bipolar Androgen Therapy involves alternating between high testosterone doses (given as gel applied to skin) and low levels, which can disrupt cancer cell growth patterns. Both are combined with ongoing androgen deprivation therapy.

Study of Debio 4228 for Patients with Advanced or Metastatic Prostate Cancer

This trial in Spain, Belgium, and France tests Debio 4228, a gonadotropin-releasing hormone antagonist given by injection, for men with locally advanced or metastatic prostate cancer.

Main inclusion criteria: Participants must be male, at least 18 years old, with confirmed locally advanced or metastatic prostate cancer suitable for continuous androgen deprivation therapy. They must have morning testosterone levels greater than 150 ng/dL at screening, good physical function (ECOG 0-2), life expectancy of at least 6 months, and adequate bone marrow, liver, and kidney function.

Main exclusion criteria: Female patients and vulnerable populations (those needing special protection or unable to give informed consent) are excluded.

Trial focus and goals: The study evaluates how Debio 4228 affects hormone levels over time, particularly its ability to maintain testosterone below specific thresholds indicating effective treatment. Researchers will monitor for 12 weeks using regular blood tests, imaging studies, and assessments of injection site reactions. Secondary evaluations include changes in PSA levels and overall health indicators including heart function.

Investigational drugs: Debio 4228 is an extended-release formulation of a gonadotropin-releasing hormone antagonist administered by intramuscular injection. It works by blocking hormones that stimulate prostate cancer growth, helping to lower testosterone levels.

Study of ifinatamab deruxtecan alone or in combination with other treatments for patients with metastatic castration-resistant prostate cancer

This trial across seven European countries (Poland, France, Ireland, Spain, Netherlands, Italy, Germany) tests ifinatamib deruxtecan, either alone or combined with other medications, for men with metastatic castration-resistant prostate cancer whose disease has progressed despite hormone therapy.

Main inclusion criteria: Participants must be male, at least 18 years old, with confirmed prostate cancer (adenocarcinoma without small cell features) that has spread to other body parts. The cancer must show progression while on hormone therapy within 6 months before screening. Participants must have received and shown progression during or after treatment with 1 or 2 androgen receptor pathway inhibitors. They need good physical function (ECOG 0-1), adequate bone marrow, liver, and kidney function. If receiving bone treatments, doses must be stable for at least 4 weeks. Prior treatment with PARP inhibitors (if recommended) or being unsuitable for such treatment is required.

Main exclusion criteria: Patients younger than 18, those without metastatic castration-resistant prostate cancer, female patients, those unable to provide informed consent, patients with severe autoimmune disease, active infections (including HIV, hepatitis B or C), untreated brain metastases, other active cancers within 5 years, pregnant or breastfeeding women, those with severe organ dysfunction, psychiatric conditions affecting study compliance, or those who received previous immunotherapy with serious side effects are excluded.

Trial focus and goals: The study evaluates safety, effectiveness, and how long patients live without cancer progression. Monitoring includes PSA level measurements, imaging scans, and assessments of response to treatment and quality of life. Treatment continues until progression, unacceptable side effects, or participant withdrawal, with the study expected to continue until December 2029.

Investigational drugs: Ifinatamib deruxtecan is an antibody-drug conjugate administered through intravenous infusion that targets specific proteins on cancer cells to deliver cancer-fighting drugs directly to tumors.

Study of JSB462 and lutetium (177Lu) vipivotide tetraxetan combination for adult men with PSMA-positive metastatic castration resistant prostate cancer

This trial across seven European countries (Italy, Spain, Austria, Netherlands, Germany, Czechia, France) tests combining the experimental drug JSB462 with lutetium vipivotide tetraxetan for men with PSMA-positive metastatic castration-resistant prostate cancer.

Main inclusion criteria: Participants must be adult males with confirmed prostate cancer (adenocarcinoma) that has spread to other body parts and continues to grow despite low testosterone levels. They must have a positive gallium PET/CT scan confirming PSMA-positive cancer, at least one bone or organ metastasis on imaging, and good physical functioning (ECOG score 2 or less). Prior treatment with at least one newer hormone therapy is required, and participants may have had up to 2 previous chemotherapy treatments. If eligible for PARP inhibitors or immune checkpoint inhibitors, participants must have already received these treatments.

Main exclusion criteria: Patients with prior PARP inhibitor treatment, active brain or spinal metastases, known allergies to study medications, significant heart conditions (including recent heart attack or uncontrolled high blood pressure), severe liver or kidney problems, other active cancers (except certain skin cancers), history of seizures, major recent surgery, mental conditions affecting informed consent, female patients, or those under 18 years old are excluded.

Trial focus and goals: The study determines the most effective dose of JSB462 when combined with lutetium treatment and compares this combination to lutetium alone. Researchers will monitor cancer progression through regular imaging scans, blood tests measuring PSA levels, and quality of life assessments. Treatment may continue for up to 36 months, with the study running until December 2028.

Investigational drugs: JSB462 is taken orally once daily in tablet form and is being tested at different doses (100mg or 300mg). Lutetium (177Lu) vipivotide tetraxetan is a radioactive medication given through intravenous infusion that targets PSMA proteins on prostate cancer cells.

Study of PF-06821497 and Enzalutamide for Men with Advanced Prostate Cancer Resistant to Hormone Therapy

This large trial across 14 European countries tests whether adding the experimental drug PF-06821497 (Mevrometostat) to enzalutamide can improve outcomes for men with metastatic castration-resistant prostate cancer.

Main inclusion criteria: Participants must be male, at least 18 years old, with confirmed prostate cancer (adenocarcinoma without small cell features) that has spread to bones or soft tissues and continues to grow despite low testosterone levels (50 ng/dL or lower). The cancer must show progression through rising PSA levels, worsening soft tissue disease, or new bone lesions. Participants need good physical function (ECOG 0 or 1), life expectancy of at least 12 months, and adequate organ function. Side effects from previous treatments must have improved to mild levels.

Main exclusion criteria: Female patients and vulnerable populations (those unable to give informed consent) are excluded.

Trial focus and goals: The study compares progression-free survival (time until cancer worsens) between patients receiving PF-06821497 with enzalutamide versus those receiving a placebo with enzalutamide. The trial is double-blind, meaning neither participants nor researchers know who receives the active drug. Regular monitoring includes physical examinations, blood tests, and imaging studies to assess disease progression and treatment side effects. The study also evaluates overall survival, time to pain progression, and quality of life.

Investigational drugs: PF-06821497 (Mevrometostat) is an experimental enzyme inhibitor taken orally that targets specific pathways involved in cancer cell growth. Enzalutamide is an established hormone therapy taken orally that blocks male hormone effects on cancer cells.

Study of PF-06821497 with Enzalutamide for Men with Metastatic Castration-Resistant Prostate Cancer Previously Treated with Abiraterone Acetate

This trial across 11 European countries tests PF-06821497 (mevrometostat) combined with enzalutamide versus enzalutamide alone or docetaxel chemotherapy for men with metastatic castration-resistant prostate cancer who have already received abiraterone treatment.

Main inclusion criteria: Participants must be male, at least 18 years old, with confirmed prostate cancer (adenocarcinoma without small cell features) that has spread to bones or soft tissues shown by imaging. The cancer must continue growing despite castrate testosterone levels (50 ng/dL or lower) and must show progression through rising PSA levels, worsening soft tissue disease, or new bone lesions. Side effects from previous treatments must have improved to mild levels. Participants need good physical function (ECOG 0 or 1), life expectancy of at least 6 months, and adequate organ function.

Main exclusion criteria: Female patients and vulnerable populations are excluded.

Trial focus and goals: The study compares how long patients live without cancer worsening between those receiving PF-06821497 with enzalutamide versus enzalutamide alone or docetaxel. Participants are randomly assigned to treatment groups, with regular monitoring through blood tests, imaging scans, and health assessments. The trial evaluates overall survival, disease progression, and treatment side effects.

Investigational drugs: PF-06821497 (mevrometostat) is an experimental enzyme inhibitor taken orally in tablet form. Enzalutamide is an established androgen receptor inhibitor taken orally. Docetaxel is a taxane-based chemotherapy given intravenously that disrupts cancer cell division.

Summary

The 43 ongoing clinical trials for metastatic prostate cancer represent significant international research efforts, with studies concentrated primarily in Western and Central European countries. Notable patterns include multiple large trials testing combinations of hormone therapies with novel agents, particularly PARP inhibitors and immune checkpoint inhibitors. Several trials focus on sequencing questions – determining the optimal order and combination of treatments. A substantial number of studies target specific patient populations based on genetic markers, such as HRR gene mutations or BRCA status, reflecting the move toward personalized medicine. The geographic distribution shows strong participation from countries like Italy, Spain, France, and Germany, with many trials running across multiple nations to ensure adequate patient recruitment. Treatment approaches span from traditional chemotherapy to cutting-edge targeted therapies and immunotherapies, with particular emphasis on extending progression-free survival and improving quality of life for patients with advanced disease.

Ongoing Clinical Trials on Prostate cancer metastatic

  • Study of ifinatamab deruxtecan alone or in combination with other treatments for patients with metastatic castration-resistant prostate cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Ireland Italy The Netherlands Poland +1

  • A study to evaluate the safety and effectiveness of AZD9750 and saruparib in patients with metastatic prostate cancer

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands Spain

  • A study evaluating the efficacy and safety of inavolisib and enzalutamide in patients with metastatic castration-resistant prostate cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Spain

  • A study testing the safety and effectiveness of AZD0516 alone and with other cancer drugs in adults with metastatic prostate cancer

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Italy Poland Spain

  • A Study of Mevrometostat and Enzalutamide for Men with Metastatic Castration-Sensitive Prostate Cancer Who Have Not Received Hormonal Therapy or Chemotherapy

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia Finland France Germany +6

  • Safety Study of Tumor-Infiltrating Lymphocyte (TIL) Therapy for Patients with Metastatic Colorectal or Prostate Cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study of Darolutamide and Testosterone for Patients with Advanced Prostate Cancer Resistant to Standard Hormone Therapy

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Re-treatment with Lutetium (177Lu) Vipivotide Tetraxetan for Men with Metastatic Castration-Resistant Prostate Cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Effect of Degarelix on Prostate-Specific Membrane Antigen in Patients with Untreated Metastatic Prostate Cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland

  • Study of PF-06821497 and Enzalutamide for Men with Advanced Prostate Cancer Resistant to Hormone Therapy

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia Denmark Finland France Germany +8

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