Clinical Research Directory

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).

Prognostic Value of Early Postoperative Prostate-Specific Antigen for Oncological Outcomes After Radical Prostatectomy

This prospective observational study aims to evaluate the prognostic significance of early postoperative prostate-specific antigen (PSA) levels in patients undergoing radical prostatectomy for prostate cancer. No investigational interventions will be performed. All diagnostic procedures, follow-up assessments, and treatments will be conducted in accordance with standard clinical practice and established prostate cancer management guidelines. Participation in the study will not influence treatment decisions.

Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy Using SBRT for Prostate Cancer to Reduce Treatment Toxicity

This is a single arm trial that is recruiting a total of 50 participants that have been diagnosed with prostate bed (where the prostate was taken out) or regional (surrounding lymph nodes) recurrence of a prostate cancer following surgery. Salvage radiation treatment represents the main treatment option, with long-term cure rates on the order of 70%. Currently, salvage radiation treatment to the prostate bed and the pelvic lymph nodes is delivered using external beam radiation therapy (EBRT) in 20-33 sessions, over 4-6.5 weeks. Potential study participants have undergone a PSMA PET scan, which has found recurrent cancer in the prostate bed or lymph nodes. This study will investigate personalizing your radiation treatment based on this information. Participants on this study will receive lower than standard radiation dose to areas of the surgical site which do not show evidence of disease on the scan. This personalized radiotherapy will be delivered in 5 treatments over two weeks, rather than the four to 6 weeks which is the current standard of care. Participants will have a routine history, blood collection for PSA and hormone levels, toxicity assessment, and EPIC-26 \& IPSS questionnaires at each follow-up visit. These will take place at 1, 3, 6, 12, 24, 36, and 60 months after radiation treatment.

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).

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 clinical trial designed for patients with localized prostate cancer who do not have evidence of lymph node or distant metastases based on modern PSMA PET imaging. Prostate cancer is one of the most common cancers in men. For patients with disease confined to the prostate, radiotherapy is a well-established and effective curative treatment option. Over the past decades, research has shown that delivering higher radiation doses to the prostate can improve cancer control and reduce the risk of disease recurrence. However, higher radiation doses may also increase the risk of side effects affecting urinary, bowel, and sexual function. For this reason, different radiation techniques have been developed to safely deliver higher doses while protecting surrounding healthy organs. Several approaches to radiation dose escalation are currently used in clinical practice. These include stereotactic body radiotherapy (SBRT), which delivers radiation in a small number of highly precise treatments, as well as brachytherapy, where radioactive sources are placed directly inside the prostate for a short time (high-dose-rate brachytherapy) or permanently (low-dose-rate brachytherapy). Although all these approaches are accepted and widely used, it is not known which strategy provides the best balance between cancer control, treatment-related side effects, and long-term quality of life, particularly when modern imaging techniques are used to accurately stage the disease. The PRO-BOOST-LC study aims to directly compare different radiation dose escalation strategies using a standardized treatment framework. All participants enrolled in the study will have localized prostate cancer staged with PSMA PET imaging to exclude metastatic disease. Participants will then be randomly assigned to one of four treatment groups. One group will receive SBRT alone to the prostate. The other three groups will receive a short course of external beam radiotherapy followed by an additional focused radiation boost delivered using one of three methods: high-dose-rate brachytherapy, low-dose-rate brachytherapy, or SBRT. All treatment approaches used in this study are established methods routinely applied in clinical practice. Randomization ensures that each participant has an equal chance of being assigned to any of the treatment groups. This allows the study to fairly compare outcomes between the different strategies. The main objective of the trial is to determine whether adding a radiation boost improves treatment outcomes compared with SBRT alone. The primary outcome measure is failure-free survival, which includes cancer recurrence, disease progression, the need for additional cancer treatment, or death from any cause. Secondary outcomes include the development of distant metastases, overall survival, treatment-related side effects, and patient-reported quality of life. Participants will be closely monitored throughout the study. Before treatment, patients will undergo clinical evaluation, blood tests including prostate-specific antigen (PSA), imaging studies, and quality-of-life assessments. During and after treatment, participants will attend regular follow-up visits. These visits will include clinical examinations, PSA testing, assessment of treatment-related side effects, and completion of standardized questionnaires evaluating urinary, bowel, and sexual function, as well as overall quality of life. Imaging studies, including PSMA PET scans, will be performed when clinically indicated to assess for possible disease recurrence or progression. The study is designed to follow participants for many years in order to capture both early and long-term outcomes. By using modern radiotherapy techniques, standardized treatment protocols, and comprehensive follow-up, PRO-BOOST-LC aims to generate high-quality evidence that will help guide future treatment decisions for patients with localized prostate cancer. The results of this trial are expected to improve understanding of how best to use radiation dose escalation to maximize cancer control while minimizing side effects and preserving quality of life in the era of advanced imaging and precision radiotherapy. Participation in this study does not involve experimental or unproven treatments. All radiation techniques used in PRO-BOOST-LC are approved, widely available, and considered standard of care in many treatment centers worldwide. The study focuses on optimizing how these existing techniques are combined and delivered, rather than introducing new drugs or devices. Participation may involve additional follow-up assessments and questionnaires compared with routine care, but treatment decisions are made within established clinical practice guidelines. Patients may or may not directly benefit from participation, but the information gained from this study may help improve future treatment strategies for men with localized prostate cancer.

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 Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec

Phase 2a, open-label, multi-center study evaluating biomarkers and biodistribution of aglatimagene besadenovec plus valacyclovir in men with localized, intermediate-risk prostate cancer who are planning to receive external beam radiation therapy (EBRT).

Study of the Epidemiological, Clinical, Diagnostic, and Therapeutic Characteristics of Prostate Cancers in Algeria

The goal of this observational study is to describe the demographic, epidemiological, clinical, and outcome characteristics of patients with prostate cancer. It also aims to analyze the diagnostic approaches and management strategies used in the care of these patients in Algeria.

PRIAPUS-PCa Study: Stereotactic Body Radiation Therapy (SBRT) and Androgen Deprivation Therapy (ADT) Impact on Sexual Function on Men With Unfavorable Intermediate Risk Prostate Cancer

This study looks at how combined radiation and hormone therapy affects sexual function in men with a specific type of prostate cancer, before and after treatment.

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

Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate Cancer

This is a Phase I/II trial evaluating the effectiveness of adding neoadjuvant HDR-B prior to RALP for HR-PCa patients with selective AAB for decipher high risk or pathologically node positive patients. Patients with newly diagnosed, histologically confirmed, non-metastatic, HR-PCa who are scheduled to receive RALP will be eligible to participate in the study.

Rezvilutamide for High-Risk Prostate Cancer After Surgery

The goal of this clinical trial is to learn if Rezvilutamide works to treat high-risk prostate cancer in patients who have recently undergone surgery (radical prostatectomy). It will also learn about the safety of Rezvilutamide. The main questions it aims to answer are: Does Rezvilutamide, when used as an add-on treatment after surgery, lower the risk of the cancer returning (biochemical recurrence) within 3 years? What is the 36-month metastasis-free survival (MFS) rate for patients receiving this treatment? What is the safety profile of Rezvilutamide combined with ADT, specifically regarding the types, grades, and incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Adverse Events of Special Interest (AESIs), and rare adverse events? What are the exploratory findings regarding the status of immune cells after using Rezvilutamide? Researchers will evaluate the combination of Rezvilutamide and hormone therapy (ADT) to see if it helps keep patients cancer-free. Participants will: Take Rezvilutamide: 240 mg once daily, taken orally before or after breakfast. Each cycle is 28 days, for up to 24 cycles. Treatment continues unless biochemical recurrence, disease progression, intolerable toxicity occurs, or the participant withdraws consent, as determined by the investigator. Receive Androgen Deprivation Therapy (ADT): Leuprorelin 3.75mg via subcutaneous injection, once every 28 days for a total of 12 cycles.

Predictive Factors for 10-year Biochemical Recurrence and Urinary Continence Following Robot-assisted Radical Prostatectomy for Prostate Cancer

The aim of the present project is to evaluate long-term oncological and functional treatment outcomes, as well as patient satisfaction, ten years after radical prostatectomy in patients initially enrolled in CPRRP study. This research builds on a previous five-year follow-up evaluation (approved by the ethics committee) and focuses on the durability of therapeutic effects, quality of life, and long-term complications. Data will be collected via telephone interviews assessing key parameters (PSA levels, information on subsequent radiotherapy and androgen-deprivation therapy, the ICIQ-SF and IIEF-5 questionnaires, and patient-reported quality-of-life and satisfaction measures), followed by statistical analysis.

Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer

To determine if dexamethasone or dexamethasone plus metronidazole restore sensitivity to abiraterone for the treatment of metastatic prostate cancer.

PSMA PET for Surveillance After Focal Therapy

This study is about adding PSMA PET (Prostate Specific Membrane Antigen- Positron Emission Tomography) to routine magnetic resonance imaging (MRI) scans to help detect prostate cancer recurrence in men who have undergone focal therapy for prostate cancer. PSMA PET and multiparametric (mpMRI are both imaging tests that help detect prostate cancer in the body. A PSMA PET scan, or prostate-specific membrane antigen positron emission tomography scan, is an imaging test that scans and takes pictures of the prostate. PSMA scans use a specialized radioactive imaging dye that sticks to the proteins that are typically found in prostate cancer cells. This imaging dye helps locate areas of prostate cancer anywhere in the body, both inside and outside prostate. An mpMRI, or a multiparametric (mp) MRI scan, is also an imaging test that scans and takes detailed pictures of the prostate. Unlike regular MRIs, an mpMRI produces a more detailed image of the prostate. Similar to PET scans, mpMRI scans also use an imaging dye that helps the pictures of the prostate appear clearer on scans. This study will be funded by Blue Earth Diagnostics, a molecular imaging company based in England.

ABlative Radiotherapy (for) Unfavorable Prostate Tumors 2.0

Published clinical evidence confirms that a single dose of 24 Gy provides unprecedented long-term local control in primary and metastatic prostate cancer with safe toxicity profiles, provided that exposure of surrounding healthy tissues is critically assessed with fulfillment of strict constraints and dose distribution is accomplished using image guidance and tracking tools. In the present trial, intermediate unfavorable and selected high-risk organ-confined prostate cancer patients will undergo Single Dose Radiation Therapy (SDRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume by means of image-guided volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures. Androgen Deprivation Therapy (ADT) type and duration has been set as per standard of care, in accordance with current recommendations and guidelines. The results of the study will enable us to find out if the new, shorter treatment (1 doses of radiotherapy), has a similar level of side effects as the 5 dose treatment and is suitable for further study.

Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer (X-SMILE)

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.

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.

Dose De-escalation in Prostate Radiotherapy Using an MR-Linac in Two Fractions

The goal of this clinical trial is to find out whether lowering the radiation dose to parts of the prostate without visible tumor on MRI can reduce side effects while still effectively treating prostate cancer in men with low or intermediate-risk prostate cancer. The main questions it aims to answer are: * Does reducing the radiation dose to healthy prostate tissue lower the risk of bowel and urinary side effects? * Can we maintain good cancer control by keeping a high dose for MRI-visible tumor areas? Researchers will compare two treatment approaches: * One group receives a uniform high dose to the entire prostate. * The other group receives a lower dose to healthy prostate tissue and a high dose only to visible tumor areas. Participants will: * Receive two sessions of MRI-guided radiotherapy using an MR-Linac. * Complete questionnaires about urinary, bowel, and sexual health before and after treatment. * Have follow-up visits to monitor side effects and PSA levels for up to 2 years.

Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer

The goal of this clinical trial is to determine the safety and feasibility of a new combination of darolutamide and relugolix as neoadjuvant therapy preceding radical prostatectomy (RP) for high-risk prostate cancer (PCa) in adult males.

LUtetium-177 DOsimetry as a Predictive Biomarker of Response in Metastatic Prostate Cancer Patients Treated With PSMA Radioligand THerapy.

A substantial proportion of patients with mCRPC do not respond to 177Lu-PSMA-RLT. The PSA response to Lu-PSMA was observed in nearly 46% of patients included in VISION trial and 66% in LuPSMA trial (4,5). The response to treatment can be evaluated after two cycles using the PSA or PSMA PET/CT scan. Gafita et al. Data have shown that PSA and PSMA perform equally in assessing response to 177Lu-PSMA treatment, and their changes after two cycles are related to patient survival. After two cycles, patients with no PSA or PSMA response had worse outcomes than those with partial response or stable disease . That means PSA and PSMA changes after two cycles can be used as a surrogate of patient outcome. However, the explanation of disease resistance to 177Lu-PSMA-RLT is not yet fully understood. Inappropriate dose administration might be one of the possible explanations. A dose-response relationship has been established in radiotherapy , making dosimetry a standard of care in conventional radiotherapy. In the radionuclide therapy settings, the dose-response relationship has been reported in a multi-center phase 2 trial on the selective internal radiotherapy in hepatocellular carcinoma. In this context, calculating the absorbed dose to tumour lesions could be an excellent method to individualize radionuclide therapy to achieve a maximal response to treatment. If dosimetry calculations could predict which patients would ultimately respond or not respond to treatment, administered dose and number of 177Lu-PSMA-RLT cycles could be adapted early during the treatment course. In this context, our study aims to analyze if absorbed tumour dose obtained by dosimetry calculations could be used as a biomarker to predict non-response to treatment early after one cycle, as the first step towards treatment dose adaptation of a personalized radionuclide treatment approach.

The Value of GRPR PET Imaging for Diagnosis and Staging in Prostate Cancer

The gastrin-releasing peptide receptor (GRPR) is highly expressed in prostate cancer (77%-100%). Numerous studies have confirmed that GRPR PET imaging has emerged as a significant molecular imaging modality in prostate cancer, particularly serving as a complementary tool to PSMA PET for addressing cases with negative or insufficient PSMA expression. It demonstrates substantial value in initial staging (especially in intermediate- and high-risk patients), detecting sites of biochemical recurrence, assessing metastatic lesions (notably in mCRPC), and guiding treatment decisions. 68Ga-G21 and 68Ga-G23 are two novel molecular probes targeting GRPR. This study aims to evaluate their biodistribution and diagnostic performance in prostate cancer and compare them with 68Ga-PSMA-11 PET imaging.

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

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

Adaptive Stereotactic Radiotherapy for Localized Prostate Cancer

This study evaluates whether adaptive stereotactic body radiotherapy (SBRT) provides dosimetric advantages compared to non-adaptive SBRT in localized prostate cancer. Five low-dose CT scans are performed before each SBRT session to assess anatomical variations (bladder filling, rectal volume) and determine if a dosimetric recalculation would have been required. The study also evaluates cumulative dose to organs at risk, patient-reported quality of life over 24 months, and overall and recurrence-free survival.