Clinical Trials for Prostate Diseases

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Prostate Diseases from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 23
• Active, not recruiting: 15
• Completed: 2
• Other: 10

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT03805919 — Men at High Genetic Risk for Prostate Cancer

Background:

Research studies have shown that genetic changes and family history may increase a man s risk for prostate cancer. Researchers want to follow the prostate health of men who have specific genetic changes associated with prostate cancer to help them learn more about which men are at higher risk for prostate cancer.

Objectives:

To study men with specific genetic changes and determin…

NCT04765150 — Integrating Quantitative MRI and Artificial Intelligence to Improve Prostate Cancer Classification

This study evaluates how new magnetic resonance imaging (MRI) and artificial intelligence techniques improve the image quality and quantitative information for future prostate MRI exams in patients with suspicious of confirmed prostate cancer. The MRI and artificial intelligence techniques developed in this study may improve the accuracy in diagnosing prostate cancer in the future using less in…

NCT04706663 — Precision-Based Genomics in Prostate Cancer

Background:

Prostate cancer is the most common cancer and the second leading cause of death in males in the United States. Researchers want to find additional gene mutations that may increase a man s risk for prostate cancer and may affect how aggressive the disease is.

Objective:

To look at gene mutations in men with prostate cancer as well as the course of their disease to better understan…

NCT05417594 — Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies

This study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AZD9574 individually and in combination with anti-cancer agents in participants with advanced cancer that has recurred/progressed.

NCT04923178 — A Multi-Center Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies

Background:

Tumors in the genitourinary tracts can occur in the kidney, bladder, prostate, and testicles and can have common and rare histologies. Some cancers that occur along the genitourinary (GU) tract are rare. Some GU tumors are so rare that they are not included in treatment studies or tissue banks. This makes it hard for researchers to determine standards of care. Researchers want to l…

NCT05588128 — Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL

Background:

Prostate cancer is the second leading cause of cancer-related death in American men. The disease recurs in up to 50,000 men each year after their early-stage disease was treated; however, at this stage, imaging scans are often unable to find the disease in the body. In this natural history study, researchers want to find out if a new radiotracer (18F-DCFPyL) injected before positro…

NCT05918263 — Exercise for Tumor Suppressive Impact in Men With Prostate Cancer at High-Risk of Progression on Active Surveillance: The REMOVE Trial

The purpose of this study is to determine whether a 12-week, home-based, virtually supervised exercise program will slow cancer progression of prostate cancer among men with prostate cancer at high-risk of progression undergoing active surveillance.

The name of the study intervention involved in this study is:

Aerobic high-intensity interval training (HIIT) (training exercise intervention)

NCT06205316 — SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma

This phase III trial tests the side effects of stereotactic body radiation therapy (SBRT) compared to hypofractionated radiotherapy for treating patients with prostate adenocarcinoma that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to a limited number of sites (oligometastatic). SBRT is a type of external radiation therap…

NCT06465069 — A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors

The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.

NCT06915909 — 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 cance…

NCT06526299 — Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing Disease

This phase II trial tests how well 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that remains despite treatment (resistant). Lutetium Lu 177 (177Lu), the radioactive (tracer) component being delivered by prostate-specific membrane antigen (PSMA)-617, has physical properties t…

NCT06926283 — A Study of DXC008 in Patients With Prostate Cancer and Other Solid Tumors

This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, MTD, DLT, RP2D, the PK characteristics, preliminary anti-tumor activity, the immunogenicity of DXC008 in patients with prostate cancer and other solid tumors such as Ewing sarcoma.

NCT06995898 — The Vanguard Study: Testing a New Way to Screen for Cancer

The Vanguard Study is a feasibility study to explore several aspects of evaluating multi-cancer detection (MCD) tests in a future definitive randomized controlled trial. An MCD test measures markers in the blood in order to screen for multiple cancers simultaneously. There is a need to understand how MCDs may work as cancer screening tools. The goal of cancer screening is to reduce the burden o…

NCT07005154 — A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer

Hormone therapy, or androgen deprivation therapy (ADT) is a standard way to treat prostate cancer. It works by reducing the amount of the main male sex hormone, testosterone in the body. Androgen receptor pathway inhibitors (ARPIs) are another type of hormone therapy. They either slow down how much testosterone is made or block testosterone from reaching the prostate cancer cells. Abiraterone a…

NCT06927635 — Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer

This is a single centre, interventional, randomized Phase II, two-arm prospective trial investigating if Stereotactic Body Radiotherapy (SBRT) to all sites of Oligopressive (OP) disease while remaining on current Systemic Therapy (ST) will improve biochemical control compared to Standard of Care (SoC) (which involves a change in ST) for patients with OP Castrate Resistance Prostate Cancer (CRPC).

NCT07406282 — A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics

Prostate cancer is the most common non-skin cancer among men in the United States. For some men, the cancer has already spread to other parts of the body at the time of diagnosis; this is called metastatic hormone-sensitive prostate cancer (mHSPC). Treatment for mHSPC has advanced significantly, with new standards of care involving androgen deprivation therapy (ADT) combined with drugs known as…

NCT07114601 — A Study of LY4257496 in Participants With Cancer (OMNIRAY)

The main purpose of this study is to evaluate safety, tolerability, and efficacy of LY4257496 alone and as part of relevant standard of care (SOC) combination therapy in participants with Gastrin-releasing Peptide Receptor (GRPR)-positive advanced cancer, including but not limited to breast, colorectal, prostate, endometrial, esophageal, gastroesophageal (GE) junction, and gastric cancer. The s…

NCT07685847 — Clinical Evaluation of the Efficacy and Safety of a Medical Device in the Form of Rectal Suppositories (Prospidol®) for the Treatment of Symptoms Associated With Chronic Prostatitis/Chronic Pelvic Pain Syndrome.

The goal of this clinical trial is to evaluate whether a medical device is effective and safe in treating chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) in adult men.

The main questions it aims to answer are:

• Does the treatment reduce pain symptoms (measured by NIH-CPSI score) by more than 30% after one month?
• Does the treatment improve urinary symptoms, quality of life, and s…

NCT07288359 — Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

Phase I: Characterize safety and tolerability of GVV858 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation.

Phase II: Further characterize the safety and tolerability of GVV858 in combination with fulvestrant in patients with hormone receptor-positive/human epidermal growth factor receptor 2-…

NCT07690579 — Social, Structural, and Lifestyle Drivers of Prostate Cancer Disparities

Prostate Cancer (PC) is the most common non-cutaneous malignancy diagnosed and second leading cause of cancer death among men across the United States. PC among Black men accounts for a higher proportion alike of cancer diagnoses and deaths. In the prostate specific antigen (PSA)-based screening era, mortality rates improved at a similar velocity among Black and White men, but the 2- to 3-fold …

NCT07296887 — CARE Tool Study Aim 3

This study is a multi-site randomized trial to study the implementation of the CARE Tool and evaluate the CARE Tool. The CARE Tool is a web-based tool that gives people information about cancer care costs, health insurance, and resources to help with costs. Overall, the study aims to help patients with cancer overcome barriers they face navigating insurance and accessing financial resources.

NCT07689656 — A Clinical Study of [68Ga]Ga-ELI421 Injection PET Imaging in Patients With Prostate Cancer

Primary Objective:

To evaluate the safety and tolerability of PET imaging following a single intravenous infusion of [⁶⁸Ga]Ga-ELI421 injection in patients with prostate cancer.

Secondary Objectives:

To evaluate the biodistribution characteristics of [⁶⁸Ga]Ga-ELI421 injection; To evaluate the radiation dosimetry characteristics of [⁶⁸Ga]Ga-ELI421 injection; To evaluate the diagnostic ef…

NCT07690917 — A Study of a New PET Scanner in People With Cancer

The researchers are doing this study to test the capabilities of a new total-body PET scanner called the Biograph Vision Quadra. The researchers want to learn whether this scanner can produce better PET/CT images and provide more useful imaging information than standard PET/CT scanners.

Active, Not Recruiting

NCT00352924 — Agriculture Health Study

The “Agricultural Health Study” (AHS) is a collaborative effort between the National Cancer Institute and the National Institute of Environmental Health Sciences. The U.S. Environmental Protection Agency and the National Institute for Occupational Safety and Health are providing support for a limited exposure assessment effort.

Initial data collection on a prospective cohort of 89,658 study su…

NCT01140373 — Adoptive Transfer of Autologous T Cells Targeted to Prostate Specific Membrane Antigen (PSMA) for the Treatment of Castrate Metastatic Prostate Cancer (CMPC)

This is a phase I study which will test the safety of different doses of the patients own immune cells which have been changed to help recognize and destroy the cancer cells. The investigators want to find out what effects, good and/or bad, it has on the body and on the prostate cancer. The immune cells (T cells) used in this study will be the patients own immune cells. They will be removed fro…

NCT02484404 — Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can…

Background:

- Durvalumab is a drug that may help people s immune systems respond to and kill cancer cells. Olaparib is a drug that may inhibit repairing DNA damage of cancer cells. Cediranib is a drug that may stop the blood vessel growth of cancer cells. This study has two components. In the phase 1 component of the study, researchers want to investigate how well participants tolerate the co…

NCT02465060 — Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

This phase II MATCH screening and multi-sub-trial studies how well treatment that is directed by genetic testing works in patients with solid tumors, lymphomas, or multiple myelomas that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and does not respond to treatment (refractory). Patients must have progressed following at leas…

NCT07669337 — Conventional Fluid Management Versus Plethysmography Variability Index-based Goal-directed Fluid Management in Patients Undergoing Transurethral Resection of the Prostate

Transurethral resection of the prostate (TURP) is a widely performed surgical procedure for the management of benign prostatic hyperplasia. Because of the constant and frequently undetectable fluid exchange through the open prostatic venous sinuses, it is difficult to determine the precise amount of irrigating fluid absorbed after TURP surgery. Unpredictable intravascular volume changes may res…

NCT03431350 — A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

The purpose of this study is to: a) establish the recommended phase 2 dose (RP2D) and to evaluate the antitumor activity and safety of niraparib combination therapies (Combinations 1 and 2) and b) to determine the relative bioavailability of niraparib and abiraterone acetate (AA) in combination (Combination 3) in participants with metastatic castration-resistant prostate cancer (mCRPC).

NCT03976843 — Prostate Specific Membrane Antigen (PMSA)-Based PET Imaging of High Risk Prostate Cancer

Background:

People with prostate cancer usually have their cancer imaged with a CT scan and bone scan. They then have their prostate gland removed. Researchers want to test a scan that might predict if prostate cancer will return after this surgery.

Objective:

To test if a PET/CT scan before the prostate gland is removed can predict if prostate cancer will return. Also, to test if this appro…

NCT04521686 — Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations

This is an open-label, multicenter Phase 1 study to evaluate safety, tolerability and preliminary efficacy of oral LY3410738 in patients with isocitrate dehydrogenase 1 (IDH1) arginine 132 (R132)-mutant advanced solid tumors, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma or isocitrate dehydrogenase 2 (IDH2) arginine 140 (R140) or arginine 172 (R172) mutant cholangi…

NCT04624256 — Germline DNA-Based Radiosensitivity Biomarker Influence on Toxicity Following Prostate Radiotherapy, GARUDA Trial

This trial studies the changes in long-term physician-scored genitourinary toxicity achieved in prostate cancer patients eligible for stereotactic radiation therapy when both patients and physicians have access to convincing but non-validated germline signature that can characterize patients as having a low or high risk of developing toxicity after radiation therapy. The information learned fro…

NCT04689828 — 177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer

The purpose of this study is to determine whether 177Lu-PSMA-617 improves the Radiographic progression-free survival (rPFS) or Overall Survival (OS) compared to a change in Androgen receptor-directed therapy (ARDT) in metastatic castrate resistant prostate cancer (mCRPC) participants that were previously treated with an alternate ARDT and not exposed to a taxane-containing regimen in the CRPC o…

NCT05705921 — Standard Moderately Hypofractionated RT vs. Ultra-hypofractionated Focal Lesion Ablative Microboost in Prostate Cancer

EBRT is one of the standard treatment options for patients with localized PCA. Based on the outcome of randomized trials, moderately hypofractionated RT(19-25 fractions of 2.5-3.4Gy) is considered equivalent to conventional fractionated schemes with 35-39 fractions of 2Gy. A schedule of 20 fractions to a dose of 60-62Gy is adopted as standard of care for all risk-groups. Driven by the success o…

NCT07047118 — A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

This Phase II study aims to evaluate the efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg QD doses + lutetium (177Lu) vipivotide tetraxetan (hereafter referred as AAA617) compared with AAA617 (control) in participants with metastatic Castration Resistant Prostate Cancer (mCRPC) with prior exposure to at least 1 Androgen Receptor Pathway Inhib…

NCT07082049 — AI-LLM Communication Aid in Prostate Cancer Care (AI-CAP）

The goal of this clinical trial is to evaluate the efficacy of large language model (LLM)-assisted communication on psychological distress alleviation and healthcare efficiency improvement in prostate cancer patients. The main questions it aims to answer are:

Does LLM-assisted communication reduce preoperative anxiety and negative emotion more effectively than standard care? Can LLM-assisted c…

NCT07174063 — A Phase I Study of JSB462 (Luxdegalutamide) in Japanese Patients With Metastatic Prostate Cancer

This Phase I study aims to evaluate the safety, tolerability and PK of JSB462 in Japanese patients with metastatic prostate cancer.

NCT07344779 — A Study to Learn How Men With Advanced Prostate Cancer Respond to Treatment With Darolutamide and Hormone Therapy, With or Without Chemotherapy, in Real-world Medical Practice

This is an international, prospective, open-label, multicenter, multi-cohort, non-interventional observational study designed to describe the real-world effectiveness and safety of darolutamide in combination with androgen deprivation therapy (ADT), with or without docetaxel, in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The study aims to enroll approximately 1,600 male…

Not Yet Recruiting

NCT07690462 — Infrared Fluorescence Staining Versus Frozen Section for Prostate Cancer Surgery

This study aims to validate the accuracy of the infrared fluorescence rapid detection technique for the diagnosis of prostate biopsy specimens, and to compare it with intraoperative frozen section and conventional paraffin section (the gold standard), so as to evaluate its feasibility and value in clinical application.

NCT07688447 — Multicenter Randomized Controlled Trial of ThuLEP Versus ThuLEP Combined With Bladder Neck Incision in Patients With Small-Volume Benign Prostatic Hyperplasia

With the increasing degree of population aging, the number of patients undergoing surgical treatment for benign prostatic hyperplasia (BPH) is steadily rising. Among them, patients with small-volume prostates (≤30 mL) represent a distinct clinical subgroup.

This population has several unique characteristics:

1. Approximately 17.5% of patients show suboptimal postoperative outcomes.
2. The inc…

NCT07686380 — IL-15 Superagonist With or Without Vaccine in Biochemically Recurrent Prostate Cancer After Previous Stereotactic Body Radiation Therapy

Background:

Biochemically recurrent prostate cancer (BCR) occurs when prostate-specific antigen (PSA) levels in the blood rise after surgery or radiation. BCR affects 30,000 to 50,000 men each year. Researchers want to know if a drug (N-803) alone or combined with a vaccine (ETBX-071) can reduce PSA in BCR prostate cancer after radiation.

Objective:

To test a study drug alone and combined wi…

NCT07574541 — Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance

Background:

Prostate cancer is the second most common cause of cancer-related death among men in the United States. Early-stage, low-grade prostate cancer is managed with active monitoring. However, 35% of men with this cancer will need treatment within 5 years because of tumor growth. Researchers want to know if a new vaccine that targets 3 anti-cancer proteins (TriAdeno) plus a drug (N-803) …

NCT07667400 — Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer

Background:

Head and neck cancers (HNCs) account for about 5% of all cancers worldwide. They grow in the mouth, throat, nasal cavity, or salivary glands. Prostate cancer is the most common cancer in men in the United States. Survival rates for these cancers are lower than 50% if they spread to other parts of the body or return after treatment. Better treatments are needed.

Objective:

To test…

NCT07430423 — The FLOW Registry.

The purpose of this study is to create a database and prospective registry for data collection on patients with benign prostatic hyperplasia undergoing Aquablation of the prostate. All patients undergoing Aquablation of the prostate will be enrolled in the registry. Historical data from 1/1/2024- 11/30/2025 will be added through chart review. Current and future patient data will be collected th…

NCT07682649 — Escalating Cycle 1 Dose of Lu-177-PSMA-617 for the Treatment of Metastatic Castration Resistant Prostate Cancer

This phase I trial studies the safety, side effects, and treatment cycle 1 best dose of Lu-177-PSMA-617 in patients with prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castration-resistant) and has spread from where it first started (primary site) to other places in the body (metastatic). Lu-177-PSMA-617 is a radioactive drug. …

Enrolling by Invitation

NCT00102544 — Use of Tracking Devices to Locate Abnormalities During Invasive Procedures

This study will evaluate the accuracy and effectiveness of an experimental tracking device for locating abnormalities during invasive procedures, such as biopsy or ablation, that cannot easily be visualized by usual imaging techniques, such as computed tomography (CT) scans or ultrasound. Some lesions, such as certain liver or kidney tumors, small endocrine abnormalities, and others, may be har…

NCT07690306 — Development and Validation of a Non-Invasive AI Diagnostic Model for Prostate Cancer Using Multiparametric MRI and PSMA PET/CT

Prostate cancer is one of the most common malignancies in men. Currently, due to the limited diagnostic accuracy of existing imaging tests, there is a risk of missed diagnosis or unnecessary prostate biopsy. This study aims to develop and validate a non-invasive artificial intelligence (AI) diagnostic model using two advanced imaging techniques: multiparametric MRI (mpMRI) and PSMA PET/CT. By i…

NCT07328516 — Natural History Study of Early Life Exposures in Agriculture (ELEA)

Study Description:

ELEA is an observational cohort study that will collect exposure information and biospecimens from the adult children of the Agricultural Health Study (AHS) cohort (https://aghealth.nih.gov/about; Protocol OH93NCN013).

The primary hypothesis is that early life exposures, particularly those found in the agricultural environment, are associated with cancer and other adverse h…

Completed Trials

NCT03345563 — Project HERO: Health Empowerment & Recovery Outcomes

Project HERO is a 12-week study of the efficacy of Body Mind Training (BMT, i.e. Tai Chi and Qigong in this project) for reducing fatigue in male cancer survivors. This 3-arm randomized clinical trial will examine inflammatory biology and selected gene-expression pathways that are hypothesized to contribute to the intervention’s effect.

NCT04560452 — Drug Intensive Monitoring Study of Olaparib in Clinical Practice Among Chinese Patients

This is a multi-centre, prospective, non-interventional study. The study will enrol about 860 Chinese cancer patients from around 56 sites. For OC cohort, the subjects who had received olaparib for at least one dose before study enrolment in real world practices will be enrolled ( n=800) . For PC cohort, according to the doctor’s decision, patients who have prescribed and agreed to start taking…