Ongoing Clinical Trials for Prostate Cancer Recurrence
There are currently 4 ongoing clinical trials exploring new treatment approaches for prostate cancer that has returned after initial treatment. These studies are investigating advanced imaging-guided therapies, light-activated treatments, hormone therapy combinations, and radioactive targeted therapies across multiple countries in Europe.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Denmark
- Finland
- Germany
- Hungary
- Italy
- Netherlands
- Poland
- Portugal
- Slovakia
- Spain
- Sweden
- Study on Adding Apalutamide to Radiotherapy and LHRH Agonist for High-Risk Patients with Hormone-Sensitive Prostate Cancer
- Study Comparing Conventional Radiotherapy and PSMA-PET/CT Targeted Treatment with 18F-PSMA-1007 and Gozetotide for Prostate Cancer Recurrence After Surgery
- Study on the Safety and Effectiveness of SpectraCure P18 System and Verteporfin for Treating Recurrent Prostate Cancer
Study Comparing Conventional Radiotherapy and PSMA-PET/CT Targeted Treatment with 18F-PSMA-1007 and Gozetotide for Prostate Cancer Recurrence After Surgery
This trial is designed for men who have experienced a biochemical recurrence after prostate surgery. Biochemical recurrence means that PSA levels, a protein marker in the blood, have started to rise again, suggesting cancer may still be present. The study compares two treatment approaches: standard salvage radiotherapy and a personalized treatment guided by PSMA-PET/CT imaging.
Inclusion criteria: To participate, you must be a male patient who previously underwent radical prostatectomy for prostate cancer. Your PSA level should be between 0.2 and 2.0 ng/mL and rising, confirmed by two separate tests. A multidisciplinary medical team must have recommended salvage radiotherapy as your treatment option. You must also sign an informed consent form agreeing to participate after understanding all study details.
Exclusion criteria: This study does not include female patients or those who have not experienced biochemical recurrence after surgery. Vulnerable populations, such as those unable to provide proper consent, are also excluded.
Treatment focus: The main goal is to determine which approach better prevents cancer progression, measured by PSA levels over time. The individualized treatment uses specialized imaging to identify exactly where cancer cells may have returned, allowing for more targeted therapy. Participants will be monitored to assess treatment response, time to cancer spread, overall survival, and quality of life.
Investigational treatments: The study tests PSMA-PET/CT targeted treatment, which uses special imaging tracers called 18F-PSMA-1007 and gozetotide. These substances are injected into a vein to highlight cancer cells during scanning, helping doctors target treatment more precisely to areas where cancer has returned.
Study on the Safety and Effectiveness of SpectraCure P18 System and Verteporfin for Treating Recurrent Prostate Cancer
This study investigates a treatment approach called photodynamic therapy for men whose prostate cancer has returned after initial radiation treatment. The approach combines a light-activated drug called verteporfin with a specialized laser system.
Inclusion criteria: Men over 18 years old who have received radiation therapy for prostate cancer and now have confirmed cancer recurrence in the prostate can participate. For the first phase, the cancer area to be treated must be smaller than 50 cubic centimeters, as measured by specialized ultrasound. Participants should not be eligible for additional surgery or curative radiation therapy. You must have adequate blood cell counts, good kidney function with creatinine levels at 1.5 mg/dL or below, and proper liver function. Your expected survival should be at least 8 months for phase 1 or 12 months for phase 2. You must be able to perform normal daily activities or have only mild symptoms. Informed consent is required from all participants.
Exclusion criteria: Only men with confirmed recurrent prostate cancer can participate. Vulnerable populations who cannot provide proper consent are excluded.
Treatment focus: The study aims to assess the safety and effectiveness of combining the SpectraCure P18 System with verteporfin. This combination uses light therapy to destroy cancer cells while minimizing damage to healthy tissue. Researchers will monitor how well patients tolerate the treatment, any side effects, and how the cancer responds using MRI imaging.
Investigational treatments: The SpectraCure P18 System uses multiple small lasers with specialized software called IDOSE to deliver precisely calculated amounts of light to cancer cells. Verteporfin is a drug injected into the bloodstream that becomes active when exposed to this light, producing substances that kill cancer cells in a process called photodynamic therapy.
Study on Adding Apalutamide to Radiotherapy and LHRH Agonist for High-Risk Patients with Hormone-Sensitive Prostate Cancer
This large international trial examines whether adding a medication called apalutamide to standard treatment can improve outcomes for high-risk patients with hormone-sensitive prostate cancer. The standard treatment consists of radiotherapy combined with LHRH agonist hormone therapy.
Inclusion criteria: You must be 18 years or older with confirmed adenocarcinoma of the prostate proven through tissue examination. Previous treatment should include radical prostatectomy or external-beam radiotherapy. Your PSA levels must show biochemical recurrence with levels greater than 0.5 μg/L or more than 2.0 above the lowest level reached after treatment. Your PSA doubling time must be less than 6 months, meaning PSA levels double in under 6 months based on two consecutive rising measurements at least one week apart. You must have adequate organ function, including sufficient blood cell counts, kidney function, and liver function. Your performance status should be grade 0 or 1, meaning you can carry out normal activities or light work. You must be able to swallow tablets or mix them with applesauce. Male participants engaging in sexual activity with someone who can become pregnant must use a condom plus another effective birth control method during treatment and for 3 months after. If receiving bone-loss prevention treatment, doses must be stable for at least 4 weeks before starting the study.
Exclusion criteria: Female patients cannot participate. Those who are part of vulnerable populations requiring special protection are excluded.
Treatment focus: The study investigates whether adding apalutamide to the standard combination of radiotherapy and LHRH agonist can delay cancer spread or death. Special PSMA-PET imaging is used to monitor cancer progression. The trial will track how long patients remain free of cancer spread, overall survival, and quality of life.
Investigational treatments: Apalutamide is a tablet taken by mouth that blocks male hormones from promoting cancer cell growth. Radiotherapy uses high-energy rays to target cancer cells. LHRH agonist is a hormone therapy given by injection under the skin to lower male hormone levels in the body, helping slow or stop cancer growth.
Study on the Safety of Lutetium (177Lu) Zadavotide Guraxetan and Radium Ra 223 Dichloride for Patients with Bone-Metastatic Prostate Cancer
This trial explores using two different radioactive treatments in alternating sequence for patients whose hormone-sensitive prostate cancer has spread to the bones. Both treatments deliver radiation directly to cancer sites while minimizing damage to healthy tissue.
Inclusion criteria: You must have histologically confirmed prostate adenocarcinoma proven by tissue examination. Previous curative treatment should include either radical prostatectomy or external-beam radiotherapy. Your performance status must be 0 or 1 on the ECOG scale, meaning you are either fully active or restricted only in strenuous activity. Life expectancy should exceed 12 months. You must have biochemical recurrence with PSA greater than 0.5 μg/L or more than 2.0 above the lowest level reached. PSA doubling time must be less than 6 months. PSMA-PET/CT imaging must show cancer spread to bones or lymph nodes, with at least 2 but no more than 5 bone metastases. At least one lesion must show strong PSMA uptake with a SUVmax greater than 15. Local treatment with radiotherapy or surgery must no longer be an option. You must not have received prior hormonal therapy or taxane-based chemotherapy. Your testosterone level must be greater than 1.7 nmol/L. Blood tests must show adequate white blood cell count, platelet count, hemoglobin levels, and kidney function.
Exclusion criteria: Only male patients with confirmed prostate cancer can participate. Vulnerable populations at higher risk of harm or exploitation are excluded.
Treatment focus: The study assesses the safety and feasibility of alternating between two radioactive treatments. Researchers will monitor how well patients tolerate the treatments, any side effects, quality of life, and cancer progression over time. Regular assessments include PSA level monitoring and PET/CT imaging to track treatment response.
Investigational treatments: Radium-223 is a radioactive substance given by injection into a vein that delivers radiation directly to cancer cells in bones, helping to kill them and reduce pain. Lutetium-177-PSMA combines a radioactive substance with a molecule that specifically targets prostate cancer cells, delivering radiation directly to them. This treatment binds to a protein called PSMA that appears in high amounts on prostate cancer cells, allowing targeted destruction while minimizing harm to healthy tissues.
Summary
Four clinical trials are currently investigating different treatment approaches for recurrent prostate cancer across Europe. The trials span 13 countries, with notable concentration in Sweden, which hosts three of the four studies. Germany also hosts two trials, while the Netherlands has one study focused specifically on bone-metastatic disease.
The research reflects diverse therapeutic strategies. Two studies explore imaging-guided treatments using PSMA-PET/CT technology to personalize therapy based on where cancer has returned. One trial investigates photodynamic therapy combining light and medication, while another examines hormone-blocking medication combined with standard treatments. The fourth study explores radioactive treatments that target cancer in bones.
Most trials focus on men who have experienced biochemical recurrence, indicated by rising PSA levels after initial surgery or radiation. The international study on apalutamide stands out as the largest, recruiting across 13 European countries. Treatment approaches range from oral medications and injections to specialized light therapy and radioactive substances delivered intravenously.
These studies aim to provide new options for managing cancer recurrence, particularly for patients whose cancer returns despite initial curative treatment. Each trial carefully monitors safety, treatment response, and quality of life to determine whether these approaches offer meaningful benefits.
