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 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 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.
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.
Belgium
