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Clinical Trials for Hormone-Refractory Prostate Cancer

This article provides information about 40 ongoing clinical trials investigating new treatments for hormone-refractory prostate cancer (also known as castration-resistant prostate cancer, metastatic castration-resistant prostate cancer, mCRPC). These trials are testing various medications and treatment combinations across multiple European countries, offering potential options for patients whose cancer continues to progress despite hormone therapy.

Clinical trial locations

Study Comparing BMS-986365 with Other Treatments for Patients with Metastatic Castration-resistant Prostate Cancer

This trial is comparing a new medication called BMS-986365 with existing treatments for metastatic castration-resistant prostate cancer, a condition where cancer has spread and continues to grow despite treatments that lower testosterone levels.

Who can participate: Men aged 18 or older with confirmed metastatic castration-resistant prostate cancer that is getting worse. You should have evidence of cancer spreading, visible on scans, and should have previously tried certain treatments for prostate cancer. You must also have recovered from side effects of previous treatments.

Who cannot participate: Patients without this specific type of prostate cancer, female patients, and those considered part of vulnerable populations.

What the study involves: The trial compares BMS-986365 with other approved medications chosen by doctors, such as Docetaxel or medications that inhibit the androgen receptor pathway. The study monitors how long it takes for the cancer to worsen and overall survival. BMS-986365 works by targeting specific pathways involved in cancer cell growth, aiming to slow down or stop cancer spread.

Medications tested: BMS-986365 is an experimental medication administered orally in capsule form. Docetaxel is a chemotherapy given through intravenous infusion that stops cancer cells from growing. Second Androgen Receptor Pathway Inhibitors block receptors that help cancer grow.

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

This study compares two treatments for metastatic castration-resistant prostate cancer: Ifinatamab Deruxtecan and Docetaxel, both aiming to help patients live longer and slow cancer progression.

Who can participate: You must have confirmed prostate cancer without small cell features, have cancer that has spread shown by scans, and have previously received treatment with androgen receptor pathway inhibitors for at least 8 weeks with evidence of cancer progression. You must have recovered from previous treatment side effects.

Who cannot participate: Patients without this specific type of prostate cancer, female patients, and vulnerable populations.

What the study involves: Participants receive either Ifinatamab Deruxtecan or Docetaxel through intravenous infusion. The study monitors how long patients live and how long before cancer worsens. Ifinatamab Deruxtecan targets cancer cells by delivering anti-cancer agents directly to them. Docetaxel interferes with cancer cell growth and division.

Medications tested: Ifinatamab Deruxtecan is an experimental medication given intravenously that targets prostate-specific membrane antigen on cancer cells. Docetaxel is a well-known chemotherapy drug that disrupts cancer cell division.

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

This trial examines the combination of darolutamide (a medication that blocks male hormones) with bipolar androgen therapy (alternating between high and low testosterone levels) for metastatic castration-resistant prostate cancer.

Who can participate: Men aged 18 or older with confirmed prostate cancer that has spread and continues to grow despite hormone therapy. You must have testosterone levels below 50 ng/dl and documented disease progression while on specific hormone treatments. You must be able to perform daily activities with minimal assistance.

Who cannot participate: Patients with allergies to study drugs, serious heart problems, severe liver or kidney problems, or those currently taking certain medications that might interact with study drugs.

What the study involves: Participants receive darolutamide tablets along with bipolar androgen therapy (testosterone gel). The combination is compared to standard treatment. Regular monitoring includes blood tests, imaging scans, and quality of life assessments.

Medications tested: Darolutamide blocks testosterone effects on cancer cells. Bipolar Androgen Therapy cycles between high and low testosterone levels. Androgen Deprivation Therapy reduces male hormone levels in the body.

Study of Ebastine and Docetaxel for Treating Metastatic Castration-Resistant Prostate Cancer in Patients with Advanced Disease

This trial tests whether adding Ebastine (typically used for allergies) to Docetaxel chemotherapy can improve outcomes for metastatic castration-resistant prostate cancer.

Who can participate: You must have confirmed prostate cancer that continues to grow despite hormone therapy, with testosterone levels at or below 50 ng/dL. You should show disease progression through rising PSA levels or new lesions on scans. You need adequate organ function including bone marrow, liver, and kidneys.

Who cannot participate: Patients without metastatic castration-resistant prostate cancer, female patients, and vulnerable populations.

What the study involves: Participants receive either the combination of Ebastine tablets and Docetaxel infusion, or a placebo with Docetaxel. The study monitors cancer markers in blood and urine, PSA response, and time until cancer progression.

Medications tested: Ebastine is an antihistamine being tested for potential cancer treatment effects. Docetaxel is a chemotherapy drug that stops cancer cells from growing and dividing.

Study of Opevesostat, Olaparib, and Cabazitaxel in Patients with Advanced Prostate Cancer

This study explores the safety and effectiveness of different treatment combinations including Olaparib and Opevesostat for metastatic castration-resistant prostate cancer.

Who can participate: You must have confirmed prostate cancer without small cell features, have cancer that has spread shown by scans, and have previously received androgen deprivation therapy or surgery. You should have progressed after at least one type of hormone therapy and one or two courses of specific chemotherapy. You need adequate blood, liver, and kidney function.

Who cannot participate: Patients without metastatic castration-resistant prostate cancer, female patients, and vulnerable populations.

What the study involves: Participants receive specific medications as part of the study protocol, which may include oral dexamethasone, intravenous cabazitaxel, and oral olaparib tablets. Regular monitoring occurs throughout the study to assess treatment response and side effects.

Medications tested: MK-5684 (Opevesostat) is an investigational medication targeting specific pathways in cancer cell growth. The study evaluates its safety, tolerability, and effectiveness.

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

This double-blind trial compares PF-06821497 (Mevrometostat) combined with enzalutamide against enzalutamide with placebo for metastatic castration-resistant prostate cancer.

Who can participate: Men aged 18 or older with confirmed prostate cancer that has spread, shown by scans, and continues to progress despite low testosterone levels. You must have PSMA-positive disease on PET/CT scans and castrate testosterone levels. You should have experienced disease progression only once after using second generation androgen receptor pathway inhibitors.

Who cannot participate: Patients without progressive PSMA-positive metastatic castration-resistant prostate cancer, female patients, and vulnerable populations.

What the study involves: Participants are randomly assigned to receive either PF-06821497 with enzalutamide or placebo with enzalutamide. Both medications are taken orally as capsules or tablets. Regular monitoring includes imaging tests and blood tests to track cancer progression and overall health.

Medications tested: PF-06821497 (Mevrometostat) is an experimental medication targeting specific enzymes involved in cancer cell growth. Enzalutamide blocks androgen receptors to prevent cancer growth hormones from fueling the disease.

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

This study evaluates whether adding PF-06821497 to enzalutamide improves outcomes compared to enzalutamide alone or docetaxel chemotherapy for patients previously treated with abiraterone acetate.

Who can participate: Men aged 18 or older with confirmed prostate cancer that has spread to bones or soft tissues. You must have low testosterone levels and show evidence of progressive disease. You should have previously been treated with one androgen receptor-directed therapy and received one or two chemotherapy treatments with disease progression during or after these treatments.

Who cannot participate: Patients without metastatic castration-resistant prostate cancer, female patients, and vulnerable populations.

What the study involves: Participants are randomly assigned to receive PF-06821497 with enzalutamide, enzalutamide alone, or docetaxel. Medications are taken orally except docetaxel which is given intravenously. Regular monitoring includes blood tests, imaging scans, and health assessments.

Medications tested: PF-06821497 (Mevrometostat) is an investigational medication targeting specific pathways in cancer cells. Enzalutamide blocks androgen receptors. Docetaxel is chemotherapy that interferes with cancer cell division.

Study of Tulmimetostat (CPI-0209) for Patients with Advanced Solid Tumors and Lymphomas

This study tests CPI-0209 (tulmimetostat) for various advanced cancers including metastatic castration-resistant prostate cancer.

Who can participate: Adults aged 18 or older with advanced solid tumors or lymphomas that have progressed after standard treatment or have no effective standard treatment. You must have recovered from previous treatment side effects, have good performance status, and adequate organ function. You need at least one area of cancer visible on scans.

Who cannot participate: Patients who haven’t received standard treatment, those outside the age range, pregnant or breastfeeding patients, and those with other serious health conditions.

What the study involves: The trial has two phases. Phase 1 determines the maximum tolerated dose and Phase 2 assesses effectiveness. CPI-0209 is administered as oral film-coated tablets. Regular monitoring includes blood tests, imaging scans, and health assessments.

Medications tested: CPI-0209 is an investigational medication that works by inhibiting specific enzymes involved in DNA repair in cancer cells, potentially leading to their death.

Study on Adding Darolutamide to First-Line Treatment for Patients with Metastatic Castration-Resistant Prostate Cancer Using a Drug Combination

This trial evaluates whether adding darolutamide to standard first-line treatment can delay cancer progression.

Who can participate: You must have confirmed prostate cancer that continues to grow despite low testosterone levels, either after surgical removal of testicles or during treatment with medications that lower hormones. You must have cancer that has spread shown by imaging tests and show disease progression. You need adequate bone marrow, liver, and kidney function.

Who cannot participate: Patients without metastatic castration-resistant prostate cancer, female patients, and vulnerable populations.

What the study involves: Participants receive darolutamide oral tablets in addition to standard care chosen by the physician. The study monitors cancer progression through regular appointments including blood tests, imaging scans, and physical examinations.

Medications tested: Darolutamide blocks male hormones that can promote cancer growth. It is used alongside standard treatments and as maintenance therapy to enhance overall survival and delay disease progression.

Study on Darolutamide and Radiation Therapy for Patients with Castration-Resistant Prostate Cancer and Oligometastases

This study compares darolutamide alone versus darolutamide combined with stereotactic body radiation therapy for castration-resistant prostate cancer with limited spread (1-5 metastatic sites).

Who can participate: You must have confirmed prostate cancer without small cell features, show progressive disease after stopping certain medications, and have 1 to 5 metastatic sites treatable with stereotactic radiation. You need adequate blood pressure, liver, and kidney function. You must have had at least 3 months since prostate surgery or radiation therapy.

Who cannot participate: Patients without castrate-resistant prostate cancer with oligometastases, those with more than 5 metastatic sites, female patients, and vulnerable populations.

What the study involves: Participants receive darolutamide oral tablets. Some also receive stereotactic body radiation therapy targeting specific cancer sites. Regular monitoring includes imaging tests and blood work.

Medications tested: Darolutamide blocks androgen receptors to prevent hormone-driven cancer growth. Stereotactic Body Radiation Therapy delivers precise high-dose radiation to cancer cells while minimizing damage to healthy tissue.

Summary

These 10 clinical trials represent a diverse range of treatment approaches for hormone-refractory prostate cancer. Several notable patterns emerge from this overview. Multiple trials focus on testing novel hormonal therapies and their combinations, particularly targeting androgen receptor pathways through medications like darolutamide, enzalutamide, and abiraterone. Several studies explore radiopharmaceutical therapies using lutetium-based compounds that deliver targeted radiation directly to cancer cells. Combination therapies are prominent, with trials testing various drug pairings to enhance treatment effectiveness. Geographically, these trials span numerous European countries, with particularly strong representation in Germany, France, Spain, and Poland, providing broad access for patients across the continent. The trials generally focus on patients who have progressed after initial hormone therapy, representing an important unmet medical need in advanced prostate cancer care. Most studies emphasize safety monitoring alongside effectiveness assessments, reflecting the importance of balancing treatment benefits with quality of life considerations for this patient population.

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Ongoing Clinical Trials on Hormone-refractory prostate cancer

  • Study of AMO959, lutetium (177Lu) vipivotide tetraxetan, and a drug combination for adults with advanced prostate cancer.

    Recruiting

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

  • Study on Adding Darolutamide to First-Line Treatment for Patients with Metastatic Castration-Resistant Prostate Cancer Using a Drug Combination

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • 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

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

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on Radiotherapy and Antiandrogens for Patients with Advanced Prostate Cancer Using Abiraterone Acetate and Enzalutamide

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on Docetaxel, Cabazitaxel, and Darolutamide for Men with Metastatic Castration-Resistant Prostate Cancer

    Recruiting

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

  • Comparison of standard dosing and blood level monitoring of abiraterone acetate for patients with metastatic castration-resistant prostate cancer

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

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

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Greece Hungary Italy +5

  • Study on Capivasertib and Docetaxel for Treating Metastatic Castration-Resistant Prostate Cancer in Patients

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Greece Hungary The Netherlands +2

  • Study of Olaparib and Abiraterone for Men with Advanced Prostate Cancer Resistant to Hormone Therapy

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Italy The Netherlands Slovakia

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