Clinical Research Directory

Phase I Study of Docetaxel and 177-Lutetium-PSMA-I&T in First-Line Treatment for Patients With Metastatic Castration-Resistant Prostate Adenocarcinoma

This is a Phase I, open-label, single-center study evaluating the safety, tolerability, and recommended Phase II dose of docetaxel when combined with a fixed dose of 177-Lutetium-PSMA-I\&T in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). Patients will receive standard androgen deprivation therapy, docetaxel at escalating doses (50 mg/m², 60 mg/m², 75 mg/m² every 3 weeks), and 177Lu-PSMA-I\&T at a fixed dose of 7.4 GBq every 6 weeks (up to 4 cycles). A 3+3 dose escalation design will be employed. Secondary endpoints include safety profile, treatment-limiting toxicities, treatment completion rate, and delayed toxicity. Exploratory endpoints include PSA response, radiographic progression-free survival (rPFS), and PERCIST-based response rate.

Study of Oral MRT-2359 With Apalutamide in Prostate Cancer

This Phase 2, open-label, multicenter study is conducted in patients with castration-resistant prostate cancer. Patients in this study receive MRT-2359, an investigational oral medicine, in combination with apalutamide, an oral medicine used to treat prostate cancer. The main purpose of the study is to assess whether this treatment combination can lower prostate-specific antigen (PSA) The study will also evaluate the safety and tolerability of the treatment combination and assess additional measures of anti-tumor activity.

RegisterPROS - A Registry for Prostate Cancers

Prostate cancers are derived from epithelial cells in the prostate gland. Treatment options include surgery, medical (androgen signaling targeted and chemotherapy) and radiation therapy including radioligand therapy (RLT). Survival is linked to early and accurate diagnoses or to the effective detection of disease recurrence and/or treatment failure. One challenge is to develop accurate non-invasive tests that can detect prostate cancer disease activity. A second challenge is to evaluate the effectiveness of such biomarkers during the natural history of this disease (e.g., active surveillance). A third aim is to identify whether molecular markers can predict response to different therapies (either pre-treatment, or early on during the first few cycles of a therapy). RegisterPROS registry aims at collecting data and blood samples from patients being evaluated for PCa disease. Data will be entered prospectively and anonymized after informed consent. All physicians who treat PCas are invited to participate to the registry. Data will be evaluated within regular time frames, focusing on diagnostic accuracy for biomarkers in the different types of tumors, treatment modalities and patient outcomes (e.g. disease recurrence and survival), thereby contributing to an understanding of the role of biomarkers in tumor management.

A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate or Darolutamide

The purpose of this study is to find out whether talazoparib in combination with enzalutamide or talazoparib alone delays cancer progression in people with metastatic castration-resistant prostate cancer (mCRPC) who have homologous recombination repair (HRR) mutations and have previously received abiraterone acetate or darolutamide

Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy

The goal of this clinical trial is to learn if fezolinetant can treat hot flashes (vasomotor symptoms) in men with prostate cancer undergoing androgen deprivation therapy. The main questions it aims to answer are: * Does fezolinetant improve the frequency and severity of hot flashes? * Does fezolinetant cause any harm to the liver? * Does fezolinetant improve quality of life, sleep quality, fatigue, mood, sexual function, and metabolic parameters? Researchers will compare how people respond to fezolinetant versus a placebo, which does not contain any active medicine. Participants will: * Take fezolinetant or a placebo every day for 4 weeks * Visit the clinic once every 2 weeks for checkups and tests * Keep a diary of the number of times and intensity that they experience hot flashes

68Ga-PSMA-11 PET/MRI for Selecting Men With Prostate Cancer for Focal Therapy

Focal therapy is a minimally invasive treatment option for some men with localized prostate cancer. Unlike surgery or radiation, focal therapy treats only the area of the prostate containing clinically significant cancer, with the goal of preserving urinary and sexual function. Successful focal therapy depends on accurately identifying all areas of clinically significant prostate cancer before treatment. Currently, multiparametric magnetic resonance imaging (MRI) is the standard imaging method used to determine whether a patient is a suitable candidate for focal therapy. However, MRI may miss some clinically significant cancers, which can lead to incomplete treatment. This pilot study will evaluate whether 68Ga-PSMA-11 positron emission tomography/magnetic resonance imaging (PET/MRI) can improve the selection of men with localized prostate cancer for focal therapy compared with MRI alone. The study will enroll men with intermediate-risk prostate cancer who are already planning to undergo radical prostatectomy as part of their standard care. Participants will receive a single injection of 68Ga-PSMA-11 followed by a PET/MRI scan before surgery. The PET/MRI findings and MRI findings will be reviewed separately and compared with the prostate tissue examined after surgery, which serves as the reference standard for determining the true location and extent of cancer. The main question this study is trying to answer is whether 68Ga-PSMA-11 PET/MRI is more accurate than MRI alone in identifying men who are appropriate candidates for focal therapy. The study will also evaluate whether PET/MRI detects more clinically significant prostate cancer lesions than MRI alone. Researchers hypothesize that 68Ga-PSMA-11 PET/MRI will improve the detection of clinically significant prostate cancer and more accurately identify patients who are suitable candidates for focal therapy, potentially reducing the risk of untreated cancer remaining in the prostate after treatment. If successful, the results of this pilot study will support the development of a larger clinical trial and may help improve future treatment planning for men with localized prostate cancer.

Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer

This is an open label, phase I, multi-center study aiming to assess the safety and tolerability in patients with metastatic castration resistant prostate cancer (mCRPC).

REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients)

The goal of this study is to evaluate the recovery of erectile function at six months after hormonal therapy cessation in male patients affected by advanced prostate cancer and undergoing radiotherapy. The main questions are: * How well and how quickly do patients recover their sexual function and overall quality of life after stopping hormone therapy and receiving radiotherapy? * How do the details of the radiation treatment (like the dose and how it's delivered) relate to treatment success, side effects, and long-term outcomes such as cancer control, survival, and financial impact? Participants will receive hormonal therapy (Relugolix) following by radiotherapy. They will complete questionnaires on sexual function, quality of life, and financial impact before, during and after treatment, and attend follow-up visits for health assessments. The study will measure how many patients recover erectile function within six months of stopping hormonal therapy, how long recovery takes, how treatment doses relate to outcomes, and assess cancer control, side effects, quality of life, and survival.

PRO-BOOST-LC: Whole-Gland Boost Strategies Versus SBRT Monotherapy in PSMA-Staged Localized and Locally Advanced Prostate Cancer

PRO-BOOST-LC is a prospective, multicenter, randomized phase II/III clinical trial for men with localized or locally advanced prostate cancer without lymph node or distant metastases, confirmed using prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT). Radiotherapy is an established curative treatment option for prostate cancer. Several modern radiotherapy strategies can safely deliver high radiation doses to the prostate while limiting dose to surrounding organs. These include stereotactic body radiotherapy (SBRT), high-dose-rate (HDR) brachytherapy, low-dose-rate (LDR) brachytherapy, and combinations of external beam radiotherapy with a prostate boost. However, the optimal dose-escalation strategy for balancing cancer control, treatment-related toxicity, and long-term quality of life remains uncertain in patients staged with modern PSMA PET imaging. The aim of PRO-BOOST-LC is to compare definitive SBRT monotherapy with whole-gland prostate boost strategies delivered after a short course of external beam radiotherapy. Participants will be randomly assigned, according to center capability and patient-level technical suitability, to one of the protocol-defined treatment options. The control group receives SBRT monotherapy. The experimental groups receive external beam radiotherapy followed by one of three whole-gland boost techniques: HDR brachytherapy, LDR brachytherapy, or single-fraction SBRT boost. The primary objective is to determine whether assignment to a prostate boost strategy improves failure-free survival compared with SBRT monotherapy. Failure-free survival includes biochemical recurrence, local or regional progression, distant metastases, progression-driven salvage treatment, or death from any cause. Key secondary outcomes include metastasis-free survival, overall survival, physician-reported treatment-related toxicity, and patient-reported quality of life, including urinary, bowel, and sexual function. Participants will undergo baseline clinical evaluation, PSA testing, prostate MRI, PSMA PET/CT, and quality-of-life assessments. After treatment, participants will be followed regularly with clinical assessments, PSA testing, toxicity evaluation, patient questionnaires, and imaging when clinically indicated. The study is designed to provide long-term evidence on how best to use modern radiotherapy dose escalation for patients with PSMA-staged localized or locally advanced prostate cancer.

Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response

This study is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs? This study would like to find out if this approach is better or worse than the usual approach for prostate cancer. The usual approach for patients who are not in a study is hormone treatment with Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitor (ARPI).

Evaluation of Pelvic Floor Function and Psychosocial Sequelae Following Radical Prostatectomy for Prostate Cancer

This observational cross-sectional study aims to evaluate the effects of radical prostatectomy for prostate cancer on pelvic floor function and psychosocial well-being. The study will assess the prevalence and severity of urinary incontinence and erectile dysfunction, as well as their impact on quality of life, sexual health, self-esteem, and interpersonal relationships. Adult men who underwent radical prostatectomy at least one year before enrollment will complete a series of validated questionnaires and provide demographic and clinical information through online surveys or telephone interviews. The study will also explore whether participants received pelvic floor physiotherapy before or after surgery and whether rehabilitation is associated with better functional and psychosocial outcomes. The findings may contribute to a better understanding of the long-term consequences of radical prostatectomy and help identify opportunities to improve patient care.

Advancing Care Coordination Between Cancer and Primary Care Teams for Complex Cancer Survivors

The purpose of this randomized clinical trial is to learn if 'complex' cancer patients who receive care guided by a health system intervention, Primary Care Connect (PC2) have their risks of cardiovascular disease (CVD) managed better than those who receive usual care. This study focuses on "complex" cancer survivors who have higher CVD risk when diagnosed with cancer because they also have had a diagnosis of 1 or more chronic conditions (e.g., hypertension, diabetes, and/or hyperlipidemia) requiring medication management. This study also aims to learn about the ease of implementing the health system intervention from the perspectives of cancer teams, primary care teams, and complex cancer patients. The main questions the study aims to answer are: * Do patients enrolled in the PC2 arm remain connected to their primary care teams during active cancer treatment for chronic disease management compared to patients in usual care? * Do patients enrolled in the PC2 arm have better management of their chronic conditions during active cancer treatment compared to patients in usual care? * How do the care team and patients experience this change in care delivery related to their work and care experiences? This study will compare complex cancer survivors who receive care according to the PC2 intervention to usual care to see if PC2 works to improve cardiovascular risk management. Participants will: * receive educational materials about the study upon enrollment * complete on-line or written surveys at 4 times * Visit the clinic for check ups and test related to the study 4 times

A Single-Arm, Blinded, Fluorescent PSMA Histopathology Trial of AS1986NS

A Single-Arm, blinded, fluorescent PSMA histopathology trial of AS1986NS

Robotic Prostatectomy Artificial Intelligence Low Pressure Pain (RALP) Trial

The 'Robotic Prostatectomy Artificial Intelligence Low Pressure Pain Study Trial' aims to assess the feasibility of being able to review operative outcomes such as pain when comparing two commonly used surgical devices for the removal of prostate cancers. The data collected will inform methodologies for future, larger, multi-center trials investigating pain in patients undergoing prostate cancer surgery. A robotic prostatectomy is a commonly performed surgery used to treat prostate cancer by removing the prostate gland. In order to perform the procedure, the surgeon must 'inflate' (technical term pneumoperitoneum) the patients abdomen with carbon dioxide gas using a device called an insufflator. Adequate 'inflation' of the abdomen ensures the surgeon can clearly visualise the prostate. Unfortunately, higher pressures of abdominal 'inflation' are a large contributor to intra and post-operative pain in patients having prostatectomies. The type of insufflator device used to maintain inflation pressures in the abdomen are thought to be a variable contributing to differing levels of intra and post-operative pain. Therefore, the purpose of this trial is to compare intra and post-operative pain when using two different insufflator devices when performing robotic prostatectomies. Both insufflators are already commonly used across multiple NHS Trusts. 40 patients awaiting a robotic prostatectomy at the urology department at the Lister hospital, Stevenage, will be randomised to use either the Conventional Insufflator System (CIS) {Stryker PneumoClear Insufflator} or the AIRSEAL® Insufflation System (AIS) to 'inflate' their abdomens during their prostatectomies. Data relating to various intra and post-operative outcomes will be collected in the 30 days following the patient's operation. Outcomes include levels of intra and post-operative pain, medication use, procedure time, recovery room time, length of hospital stay, post operative nausea and vomiting and adverse events. This data can be analysed to identify trends in differences in outcomes between the AIS and CIS insufflators. An amendment has been approved to recruit an additional 60 participants, total overall recruitment is 100.

Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer

The aim of this phase II international multicenter study is to evaluate the safety, feasibility, and efficacy of CT or MRI-adaptive SBRT, delivered in five weekly fractions, in patients with newly diagnosed localized prostate cancer who have lower urinary tract symptoms and/or prostatic hyperplasia.

68Ga-P16-093 PET Imaging for Diagnosing Prostate Cancer, a Head-to-head Comparison With mpMRI

68Ga-P16-093 is a novel radiotracer targeting PSMA. In this study, we investigated the diagnostic efficacy of 68Ga-P16-093 PET imaging (PET/CT or PET/MRI) in patients with newly diagnosed, treatment-naive prostate cancer, and performed a head-to-head comparison with multi-parameter magnetic resonance imaging (mpMRI).

EFFICACY OF INTRAOPERATIVE ARISTA POLYSACCHARIDE APPLICATION ON THE POSTOPERATIVE BLOOD LOSS IN PATIENTS UNDERGOING RARP FOR THE TREATMENT OF PROSTATE CANCER

We perform a multicenter randomized controlled prospective study with superiority trial design, in which the polysaccharide ARISTA™ AH hemostat agent is applied to the neurovascular bundle areas after prostate removal, during Robot-assisted radical prostatectomy. We examine if such agent leads to a relevant clinical improvement indicated by higher postoperative hemoglobin levels compared to the control group. As an exploratory co-primary endpoint of interest, we examine erectile function after Robot-assisted radical prostatectomy based on IIEF-5 score between groups 3, 6 and 12 months after Robot-assisted radical prostatectomy

Comparative Analysis of Immunological Responses to Vitamin D Replacement Therapy in Black and West African Men Diagnosed With Prostate Cancer: Elucidating Differential Effects on Immune Function Between Patients With Localized Disease and Those With Metastatic Progression

This study is testing whether fixing vitamin D deficiency in Black/West African men with prostate cancer can strengthen their immune system, improve quality of life, and even slow cancer progression compared to those who remain deficient. Key ideas being tested: 1. More than half of Black/West African prostate cancer patients don't have enough vitamin D. 2. Low vitamin D weakens immune cell function and affects quality of life, but these problems improve after 8 weeks of vitamin D supplements. 3. Immune cell function differs between patients with advanced/recurrent prostate cancer and those with localized disease. 4. Patients with advanced disease who show stronger immune responses after vitamin D correction may live longer without their PSA levels rising (a marker of cancer progression). 5. Immune cell function in Black/West African patients is different from that in Black/African American patients, and this will be checked by comparing data with a parallel Mayo Clinic study. Overall goals: 1 . Measure how widespread vitamin D deficiency is in Black/West African prostate cancer patients. 2\. Understand how vitamin D levels affect immunity and quality of life. 3. Compare immune function between different groups (localized vs. advanced disease, West African vs. African American patients). 4 . See if vitamin D replacement improves both patient well-being and cancer outcomes. Study Flow 1\. Recruitment \& Consent: Patients with prostate cancer (localized or advanced) are invited and give written consent. 2 . Initial Blood Test (10 mL): Check vitamin D and calcium levels. 3. Eligibility: If vitamin D is low (\<30 ng/mL), patients join the treatment phase. 4\. Baseline Testing (50 mL blood + QOL survey): Immune function measured; quality of life survey completed; virtual doctor consult. 5\. Treatment (8 weeks): Daily vitamin D3 pills (2000 IU, free); patients keep a medication diary. 6\. Midpoint Check (Week 4): Phone call to check side effects and compliance. 7 .End of Treatment (Week 8): Repeat blood tests (60 mL), second QOL survey, virtual consult. 8\. Follow up (up to 3 years). Annual phone calls and medical record review to track progression-free survival. In short, the study is trying to show that vitamin D deficiency is common in Black/West African prostate cancer patients, that it harms immune function and quality of life, and that correcting it could improve both health and cancer survival.

Dyadic Co-learning Intervention for Patients With Prostate Cancer and Their Spouses

This study aims to help patients with prostate cancer and their spouses cope better with the challenges of cancer by learning and supporting each other together. The investigators will test an 8-week "Dyadic Co-learning Intervention," which includes weekly learning topics, a mobile app, and professional support. The goal is to improve their physical symptoms, emotional well-being, and resilience. Participants will be randomly assigned to one of two groups. One group will receive regular care, while the other group will receive regular care plus the new co-learning program. The investigators will ask both patients and their spouses to complete questionnaires at the beginning of the study, and again at 10 and 16 weeks, to understand how the program affects their health and well-being.

A Study to Evaluate the Performance of Confocal Microscopy to Detect Positive Margins During Radical Prostatectomy

The goal of this study is to find out whether a new method called "LaserSAFE" can accurately detect cancer at the edge of the prostate (called a positive margin) during prostate surgery. LaserSAFE uses a special microscope in the operating room to quickly scan the prostate after it has been removed from the body. This information can help surgeons decide whether it is safe to preserve the nerves around the prostate. This is especially important for patients who are not usually considered suitable for nerve-sparing surgery using current methods. The study will also assess how quickly and reliably LaserSAFE provides this information during surgery. The main questions it aims to answer are: Can LaserSAFE accurately detect cancer at the edges of the prostate during surgery? Can LaserSAFE help surgeons safely decide whether to preserve or remove the surrounding nerves? Researchers will evaluate the use of the LaserSAFE technique during surgery to see if it improves decision-making about nerve preservation compared to standard practice. Participants will: Complete a quality of life questionnaire before surgery Undergo standard prostate surgery, where the surgeon will initially try to preserve the nerves Have their removed prostate analysed during surgery using the LaserSAFE technique Have additional tissue removed if LaserSAFE detects cancer at the edges of the prostate Attend routine follow-up visits as part of standard care Complete quality of life questionnaires at 3 and 12 months after surgery

Flotufolastat F 18 PET in Men With Very Low PSA Recurrence

The purpose of this study is to assess detection rate of flotufolastat F 18 positron emission tomography (PET) for low prostate specific antigen (PSA) recurrence of prostate cancer (PC) following radical prostatectomy.

Development of a Novel Signature Integrating Clinical, Imaging And Epigenetic Information to Tailor Pelvic Nodal Treatment in Prostate Cancer

Radical prostatectomy (RP) represents one treatment option for clinically localized prostate cancer (PCa). The most updated guidelines of the European Association of Urology indicate the need to perform ePLND in patients with a lymph node invasion (LNI) risk \>5% according to the Briganti nomogram. This approach allows sparing ePLND in two thirds of contemporary surgically treated patients; however, many patients still receive ePLND in the absence of lymph node metastases. This is clinically relevant, since ePLND is associated with significant risks of complications. Improving the ability to detect LNI in PCa would be important for two main reasons: (1) enabling more timely treatments that may improve patient outcomes, and (2) avoiding significant overtreatment and reducing ePLND-related toxicity. The hypothesis of the present study is that lymphatic spread of PCa cells may be predicted through integration of clinical variables, radiologic findings, and epigenomic information. The objective of the study is to develop an accurate predictive model including radiological and epigenomic information.

Percutaneous Thermo-ablation for the Treatment of Prostate Cancer Oligometastatasis (TA-P-OLIM)

The TA-P-OLIM Study (Percutaneous Thermo-Ablation of Prostate Cancer OligoMetastasis) is a prospective, interventional phase II study designed to evaluate the feasibility, efficacy, and safety of percutaneous thermal ablation (TA) as a metastasis-directed therapy (MDT) for patients with oligometastatic prostate cancer. So far, these metastases have been locally treated with stereotactic body radiation therapy (SBRT) or surgical resection. Percutaneous TA is a minimally invasive technique that locally destroys tumor tissue using either heat (via microwave or radiofrequency ablation) or cold (via cryoablation). This is achieved by inserting specialized needles into the tumor through a small skin incision under image guidance. TA offers a valuable treatment option for patients who are not suitable candidates for SBRT, such as those with prior radiation exposure or metastases located near critical anatomical structures. In many of these cases, ablation remains feasible through the use of adjunctive thermoprotection techniques, where fluid is injected via a needle to gently displace critical structures, thereby creating a safe buffer zone during treatment. Preliminary retrospective evidence shows that TA achieves comparable local tumor control rates to SBRT/resection with minimal complications.7 As a minimally invasive procedure, TA typically requires only a brief hospital stay-often on an outpatient basis-and enables rapid recovery. This makes TA an attractive alternative to surgery, which is associated with greater morbidity, longer recovery times, and limited suitability for some patients. In contrast to SBRT, TA also allows for simultaneous tissue sampling which is completed in a single session. Moreover, it can be safely repeated in the event of local recurrence. The study focuses on patient-centered endpoints such as local control and tolerability, aiming to improve quality of life through personalized, minimally invasive treatment strategies. TA also offers an effective local treatment option for patients who are not eligible for standard treatments such as SBRT. In this way, an alternative to both SBRT and surgery is provided, enabling continued local treatment for patients. Patients are eligible if they have previously received radical treatment for prostate cancer (surgery or radiotherapy, with or without hormonal therapy), subsequently developed a limited number of metastases (1-5), and are no longer candidates for or deny SBRT. UZ Ghent, with its long-standing research expertise in metastasis-directed therapies for oligometastatic prostate cancer, coordinates the study. The project was established in collaboration with various departments within the Urological Multidisciplinary Tumor Board. Several centers in East and West Flanders have already confirmed their willingness to participate in the study.

Enhancing Readability of Lay Abstracts and Summaries for Medical Knowledge Using Generative Artificial Intelligence (BRIDGE AI 3)

This trial tests if AI can help make medical info clear and readable. Many patients struggle to find medical informations that easy to read and understand from verified medical sources. The study tests if an AI tool can assist health providers to craft clear text for patients more fast than what they do now. Health providers are split at random into two groups-one uses the AI tool and one does not. The trial tests how clear the text is, how correct it is, and how much time is saved. The aim is to see if AI can close the gap between complex research and what patients can grasp.