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Clinical Trials for Hormone-Dependent Prostate Cancer

This article provides information about 9 ongoing clinical trials investigating new treatments for hormone-dependent prostate cancer, also known as hormone-sensitive prostate cancer. These trials are testing various medications including targeted radiation therapies, hormone therapy combinations, and chemotherapy approaches across multiple countries in Europe.

Clinical trial locations

Study of luxdegalutamide and abiraterone combination in adult men with metastatic hormone-sensitive prostate cancer

This trial is testing a new medication combination for men whose cancer has spread beyond the prostate but still responds to hormone treatment. Participants will receive luxdegalutamide (also known as JSB462), an investigational drug that blocks male hormones, together with abiraterone, an established medication that reduces hormone production throughout the body. The study compares different doses of luxdegalutamide (100 mg or 300 mg daily) combined with abiraterone against standard hormone therapy.

Main inclusion criteria: Participants must be adult males aged 18 or older with confirmed prostate adenocarcinoma that has spread to other parts of the body. They must have high-volume metastatic disease, meaning at least one cancer spread to internal organs or at least four bone lesions with one outside the spine or pelvis. Physical ability must be reasonable, with an ECOG performance status of 2 or less. Testosterone levels must be below castrate levels (50 ng/dL). Recent imaging tests (within 28 days) are required to document the extent of disease.

Main exclusion criteria: Patients cannot have received previous treatment with androgen receptor pathway inhibitors. Those with a history of seizures, active brain or spinal cord metastases, severe heart conditions, or significant liver problems are excluded. Other exclusions include active infections such as hepatitis B, C, or HIV, other active cancers within the past three years, and recent major surgery within four weeks. Uncontrolled diabetes or conditions that could interfere with taking oral medications also prevent participation.

Trial focus: The study aims to determine which dose combination of luxdegalutamide and abiraterone works best while maintaining safety. Throughout the trial, doctors will track PSA levels in the blood and use imaging tests to monitor whether the cancer is shrinking. The treatment continues for several months, with regular assessments of effectiveness and side effects.

Investigational drugs: Luxdegalutamide (JSB462) is the new investigational medication that blocks male hormone effects on cancer cells. Abiraterone is an established drug that reduces hormone production throughout the body. Both are taken as oral tablets and work together with medications that lower testosterone levels.

Study on Lutetium (177Lu) Vipivotide Tetraxetan to Delay Recurrence in Adult Men with PSMA-Positive Oligometastatic Prostate Cancer

This trial focuses on oligometastatic prostate cancer, where the disease has spread to a limited number of sites (five or fewer). The study investigates lutetium (177Lu) vipivotide tetraxetan, also known as AAA617, which delivers targeted radiation directly to cancer cells. Participants will be randomly assigned to receive either this treatment or observation without active treatment, to determine if it can delay disease return or the need for further therapy.

Main inclusion criteria: Participants must have confirmed prostate adenocarcinoma with cancer that has returned after initial treatment such as surgery, radiation, or brachytherapy. The return must be demonstrated by specific PSA levels. Patients must have oligometastatic disease with five or fewer cancer spots visible on a PSMA PET/CT scan, with at least one being a distant metastasis. All cancer spots must be treatable with radiation therapy. Testosterone levels must be normal (higher than 100 ng/dL), and patients must be adults aged 18 or older.

Main exclusion criteria: Only male participants are eligible. Vulnerable populations requiring special protection or care cannot participate.

Trial focus: The study monitors how long patients can remain free from new cancer growth or the need for additional treatment. Regular imaging tests, including CT or MRI scans, track the presence of cancer. Researchers will also assess quality of life, time to cancer progression, and overall survival. The trial is expected to continue until 2030.

Investigational drug: Lutetium (177Lu) vipivotide tetraxetan (AAA617) is administered intravenously and works by delivering targeted radiation to cancer cells expressing PSMA, a protein found on prostate cancer cells, thereby damaging and potentially killing these cells.

Study on the Effectiveness of Abiraterone, Capivasertib, and Enzalutamide in Patients with Metastatic Prostate Cancer

This trial evaluates different treatment combinations based on specific genetic markers found in cancer cells. The study uses DNA analysis from blood or tumor tissue to identify which patients might benefit most from specific treatments. Several medications are being tested, including abiraterone, capivasertib, enzalutamide, niraparib, darolutamide, cabazitaxel, olaparib, docetaxel, and radium ra 223 dichloride.

Main inclusion criteria: Participants must be males over 18 years with confirmed prostate cancer starting treatment for cancer that has spread to other parts of the body. This includes patients with newly diagnosed hormone-sensitive cancer or cancer that has progressed despite low testosterone levels. Cancer spread must be confirmed by imaging tests. Participants must be in good health with adequate blood, liver, and kidney function, with albumin levels of 28 g/L or higher. Performance status should be between 0 and 2 on the ECOG scale, and patients must be able to understand and sign consent forms and agree to use effective birth control.

Main exclusion criteria: Only male patients within the specified age range can participate. Vulnerable populations requiring special protection cannot join the study.

Trial focus: The study assigns patients to treatment groups based on biomarker analysis, using DNA from tumor tissue or blood to determine the most suitable treatment. Participants receive oral or intravenous medications depending on their assigned group. Regular monitoring includes blood tests, imaging studies, and quality of life questionnaires to assess treatment effectiveness and side effects. The study evaluates progression-free survival to determine the time until disease progression.

Investigational drugs: The trial tests multiple medications including abiraterone (lowers male hormone levels), enzalutamide (blocks hormone effects), docetaxel and cabazitaxel (chemotherapy drugs that interfere with cancer cell growth), olaparib (interferes with DNA repair in cancer cells), and radium-223 (delivers targeted radiation to cancer cells in bones).

Study on the Effectiveness of Lutetium (177Lu) Vipivotide Tetraxetan with Standard Treatment for Men with Metastatic Hormone-Sensitive Prostate Cancer

This trial studies whether adding 177Lu-PSMA-617 to standard treatments can help control disease better than standard treatments alone. The cancer in this study has spread to other parts of the body but still responds to hormone therapy, though it does not respond well to current standard treatments. Standard treatments may include medications such as enzalutamide, apalutamide, darolutamide, and abiraterone acetate.

Main inclusion criteria: Participants must be men at least 18 years old with confirmed prostate cancer and a life expectancy of more than six months. They must have stable or declining (but not rising) PSA levels, with serum PSA of at least 0.2 ng/mL at 6 to 8 months after starting systemic treatment. Testosterone levels must be below 50 ng/dL. Patients must have adequate bone marrow, liver, and kidney function. They should have received 6 to 8 months of previous standard treatment and must have had a 68Ga-PSMA-11 PET/CT scan within four weeks before joining. ECOG performance status must be 2 or less. Sexually active men must agree to use condoms with additional birth control methods.

Main exclusion criteria: Patients showing signs of cancer progression, such as rising PSA levels, cannot participate. Only male patients are eligible. Vulnerable populations are excluded.

Trial focus: The study randomly assigns patients to receive either standard treatment alone or standard treatment plus 177Lu-PSMA-617, which is given intravenously. Regular assessments monitor health and treatment effectiveness through blood tests, imaging scans, and other evaluations. PSA levels are closely tracked to assess treatment response. The study aims to improve overall survival and delay disease progression.

Investigational drugs: 177Lu-PSMA-617 is a targeted therapy that delivers radiation directly to prostate cancer cells, helping to destroy them while minimizing damage to healthy tissue. Standard of Care includes the usual hormone therapy, chemotherapy, or other medications commonly used to manage this type of cancer.

Study on the Effects of Darolutamide and Drug Combination for Patients with Metastatic Hormone-Naïve Prostate Cancer

This trial explores treatments for cancer that has spread but has not yet been treated with hormone therapy. The study compares two approaches: intermittent maximum androgen blockade (iMAB), where treatment is paused after achieving good response, and continuous maximum androgen blockade (cMAB), where treatment continues without interruption. Medications used include darolutamide, goserelin acetate, leuprorelin acetate, apalutamide, relugolix, degarelix, enzalutamide, abiraterone, and triptorelin acetate.

Main inclusion criteria: Participants must be male patients with metastatic hormone-naïve prostate cancer that has spread to other parts of the body. They must have been treated with ADT (Androgen Deprivation Therapy) for 6 to 12 months and with an Androgen Receptor Pathway Inhibitor for the same duration. PSA levels must be 0.2 ng/mL or lower. Patients can have either synchronous or metachronous metastases and either high or low volume cancer. Written informed consent is required.

Main exclusion criteria: Only male patients are eligible. Vulnerable populations that may have limited ability to give informed consent are not eligible.

Trial focus: The study monitors how long patients can go without restarting hormone therapy and compares overall survival rates between intermittent and continuous treatment approaches. Regular assessments include PSA levels, testosterone levels, and quality of life measures covering physical functioning, sexual activity, and pain. The trial helps determine if taking breaks in hormone therapy can maintain cancer control while potentially improving quality of life.

Investigational drugs: Androgen Deprivation Therapy (ADT) lowers male hormone levels to slow cancer growth. Androgen Receptor Pathway Inhibitors (ARpI) block the action of male hormones on cancer cells, preventing them from growing and dividing. These medications are used together to enhance treatment effectiveness.

Study Comparing 177Lu-PSMA-617 with Standard Treatment for Men with Metastatic Hormone-Sensitive Prostate Cancer

This trial investigates the effectiveness of 177Lu-PSMA-617 used in combination with standard care compared to standard care alone. The cancer has spread beyond the prostate but still responds to hormone therapy. Standard care may include various medications such as relugolix, goserelin acetate, triptorelin acetate, degarelix, bicalutamide, apalutamide, enzalutamide, darolutamide, abiraterone, flutamide, nilutamide, buserelin, histrelin, and leuprorelin.

Main inclusion criteria: Participants must be adult males aged 18 or older who sign informed consent. Those with HIV who are healthy with low risk of AIDS-related issues can join. Patients should be new to treatment or have had minimal treatment, with up to 45 days of certain hormone treatments or surgery allowed. Previous hormone treatments for early-stage cancer must have stopped more than 12 months before enrollment and should not have lasted more than 24 months. Daily activity abilities should be rated 0 to 2 on the ECOG scale. Life expectancy must exceed nine months. Patients must have prostate cancer confirmed by biopsy that shows PSMA-positive results on a 68Ga-PSMA-11 PET/CT scan. At least one area of cancer spread must be documented. Organs must function well with adequate bone marrow reserves, normal liver and kidney function, and blood albumin levels of at least 2.5 g/dL.

Main exclusion criteria: Only males with PSMA-positive metastatic hormone-sensitive prostate cancer are eligible. Vulnerable populations are excluded.

Trial focus: Participants are randomly assigned to receive standard care alone or standard care plus 177Lu-PSMA-617, administered intravenously. Regular monitoring includes blood tests to measure PSA levels, imaging scans to track disease progression, physical examinations, side effect monitoring, and quality of life assessments. The study aims to determine if the combination treatment can improve outcomes compared to standard care alone.

Investigational drugs: 177Lu-PSMA-617 is a targeted therapy that delivers radiation directly to cancer cells by attaching to PSMA protein on their surface. Standard of Care includes regular hormone therapy, chemotherapy, or other treatments commonly used for this type of cancer.

Study comparing darolutamide versus hormone therapy (goserelin, leuprorelin, triptorelin, degarelix) in men with untreated hormone-sensitive prostate cancer

This study compares darolutamide, a new oral medication, with standard androgen deprivation therapy (ADT). The ADT medications include degarelix, leuprorelin, triptorelin, and goserelin, given as injections. The purpose is to determine if darolutamide can lower PSA levels as effectively as standard hormone therapy after 24 weeks of treatment.

Main inclusion criteria: Participants must be 18 years or older and able to swallow tablets whole. They must have adequate bone marrow function (sufficient white blood cells, red blood cells, and platelets), normal kidney and liver function, normal heart rhythm, and sufficient blood protein levels (albumin > 25). Effective birth control must be used during treatment and for three months after. Patients must have confirmed prostate cancer diagnosis through tissue examination, with either no cancer spread or no more than four confirmed spread areas (excluding internal organs). They must have no symptoms from cancer (urinary symptoms allowed), normal testosterone levels (≥ 230 ng/dL), two PSA blood test results ≥ 2 taken at least two weeks apart within the past three months, and the ability to perform normal daily activities. Those 70 years or older must have a satisfactory health assessment score. Life expectancy must be at least 12 months.

Main exclusion criteria: Previous treatment with any androgen deprivation therapy or chemotherapy for prostate cancer is not allowed. Other exclusions include age below 18 years, female gender, known allergies to study medications, presence of metastatic disease, significant heart conditions, active liver disease, severe kidney problems, recent participation in other clinical trials, seizure history, and inability to understand or sign informed consent.

Trial focus: Patients are randomly assigned to receive either darolutamide tablets or ADT injections for 24 weeks. Regular check-ups measure PSA levels and assess treatment response. The study tracks side effects and changes in quality of life. The main assessment at week 24 determines if PSA levels decreased by 80% or more.

Investigational drugs: Darolutamide blocks the effects of male hormones in the body to slow cancer cell growth. LHRH agonists and antagonists are hormone therapy drugs that reduce testosterone levels by either gradually suppressing (agonists) or immediately blocking (antagonists) testosterone production.

Study Comparing Docetaxel, Darolutamide, and ADT for Patients with Metastatic Hormone-Sensitive Prostate Cancer

This trial compares two different dosing schedules of docetaxel, a chemotherapy drug. One group receives docetaxel at 75 mg per square meter of body surface area every three weeks, while another receives 50 mg per square meter every two weeks. Both groups also receive darolutamide and androgen deprivation therapy (ADT), which reduces male hormone levels that can promote cancer growth.

Main inclusion criteria: Participants must provide written informed consent and have adequate blood test results (liver enzymes no more than 1.5 times normal limit, bilirubin within normal limit, and creatinine no more than 2 times normal limit). Sexually active male participants must use condoms with another effective birth control method during the trial and for a period after. They must be males aged 18 or older with confirmed prostate adenocarcinoma and metastatic disease confirmed by scans. Patients must be suitable for ADT, docetaxel, and darolutamide treatment. ADT treatment must have started no more than 12 weeks before joining. ECOG performance status must be 0 or 1. Blood counts must meet specific levels (hemoglobin at least 9.0 g/dL, neutrophil count at least 1.5×109/L, platelet count at least 100×109/L), without recent growth factor treatment or blood transfusion.

Main exclusion criteria: Only male patients with prostate cancer are eligible. Vulnerable populations requiring special protection are excluded.

Trial focus: The study compares the safety of the two docetaxel dosing schedules by monitoring serious side effects and neutropenia (low white blood cell count). Patients undergo six treatment cycles with regular health monitoring. The trial also assesses overall survival, time until cancer becomes hormone-resistant, and quality of life. Treatments are given either intravenously or as oral tablets.

Investigational drugs: Docetaxel is a chemotherapy medication that stops cancer cells from growing and dividing. Darolutamide blocks the effects of male hormones that promote cancer cell growth. ADT (Androgen Deprivation Therapy) reduces male hormone levels in the body to slow cancer progression. All three are used together to enhance treatment effectiveness.

Study on Lutetium-177-PSMA and 18F-PSMA-1007 for Patients with Oligo-metastatic Hormone Sensitive Prostate Cancer

This trial investigates Lutetium-177-PSMA, a form of radiation therapy that targets cancer cells, compared to the current standard care of delaying hormone therapy. The treatment involves injecting a radioactive solution designed to target and destroy cancer cells. The study monitors how cancer responds to treatment and whether it helps delay disease progression over six months.

Main inclusion criteria: Participants must have confirmed prostate cancer diagnosis with stored tumor material. Blood tests must show specific levels (white blood cells greater than 3.0 x 109/l, platelet count greater than 75 x 109/l, hemoglobin greater than 6.2 mmol/l, liver enzymes less than 3 times normal, kidney function equal to or greater than 50 ml/min). PSA level must be greater than 1.0 μg/l with PSA-doubling time less than six months, rising in at least two tests one week apart. Patients must have 1 to 5 metastases in bones or lymph nodes shown by 18F-PSMA-PET-CT. Local treatment with radiotherapy or surgery must no longer be an option. No previous hormone therapy or chemotherapy is allowed, except for local cancer treated with radiotherapy and short-term hormone therapy stopped at least six months ago. A detectable lesion on the scan with significant PSMA avidity (SUVmax greater than 15) is required. ECOG performance status must be 0-1, life expectancy more than six months, and participants must be male.

Main exclusion criteria: Only male patients can participate. Vulnerable populations who might have difficulty giving informed consent are excluded.

Trial focus: The study evaluates how effective the new treatment is in slowing disease progression over six months. Participants receive either Lutetium-177-PSMA treatment or follow standard care. Regular monitoring assesses quality of life, side effects, and cancer response. The trial aims to provide valuable information for improved treatment options.

Investigational drugs: 177Lu-PSMA RLT is a targeted radiation therapy using radioactive Lutetium-177 linked to a molecule targeting PSMA on cancer cells, delivering radiation directly to them. Deferred Androgen Deprivation Therapy delays the use of treatments that lower testosterone, which can fuel cancer growth, to manage the disease while minimizing side effects.

Summary

These nine clinical trials represent diverse approaches to treating hormone-dependent prostate cancer across multiple European countries. Several trials focus on targeted radiation therapies using lutetium-based compounds (177Lu-PSMA-617 and lutetium vipivotide tetraxetan), which deliver radiation directly to cancer cells expressing PSMA. Other studies investigate hormone therapy approaches, including newer medications like darolutamide and luxdegalutamide, either alone or in combination with established drugs such as abiraterone and enzalutamide.

The trials show particular concentration in Western European countries, with France, Germany, Belgium, and Spain hosting multiple studies. Several trials are investigating personalized treatment approaches based on genetic markers or biomarkers, reflecting the trend toward precision medicine in cancer treatment. The studies vary in their target populations, from patients with minimal disease spread (oligometastatic) to those with more widespread metastatic cancer, addressing different stages of disease progression.

Common themes across the trials include the comparison of continuous versus intermittent treatment strategies, the evaluation of combination therapies, and the assessment of newer medications against standard care. Quality of life measurements and monitoring of side effects are important components of most studies, recognizing that treatment effectiveness must be balanced with patient well-being. These trials collectively aim to improve outcomes while potentially reducing treatment burden for patients with hormone-dependent prostate cancer.

Ongoing Clinical Trials on Hormone-dependent prostate cancer

  • A study to evaluate the effects of lutetium (177lu) vipivotide tetraxetan in patients with metastatic hormone sensitive prostate cancer receiving androgen deprivation therapy.

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Ireland Spain

  • Study on Lutetium (177Lu) Vipivotide Tetraxetan to Delay Recurrence in Adult Men with PSMA-Positive Oligometastatic Prostate Cancer

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia France Germany Greece +5

  • Study comparing darolutamide versus hormone therapy (goserelin, leuprorelin, triptorelin, degarelix) in men with untreated hormone-sensitive prostate cancer

    Not recruiting

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

  • Study of Capivasertib and Abiraterone for Patients with Metastatic Hormone-Sensitive Prostate Cancer with PTEN Deficiency

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia France Germany The Netherlands +3

  • Study Comparing Docetaxel, Darolutamide, and ADT for Patients with Metastatic Hormone-Sensitive Prostate Cancer

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany

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