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Displaying 1 - 20 of 42

Open Actively Recruiting

UCLA Urology Prostate Cancer Database

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Phase: N/A
Age Group: Adults
Contact: Sarah Connor
Open Actively Recruiting

Active Surveillance for Cancer of the Prostate (ASCaP)

Active Surveillance (A.S.) of prostate cancer (CaP) is the systematic monitoring of men with low-risk, localized lesions, with curative treatment of those whose tumors show substantial progression. A.S. is different from Watchful Waiting (W.W.), which is the palliative treatment of men with progressive prostate cancer.

Phase: N/A
Gender: Male
Age Group: Adults
Contact: Merdie Delfin
Open Actively Recruiting

Hemi-Gland Cryoablation for Prostate Cancer at UCLA

This is a prospective data collection of men who are electing to undergo prostate hemi-gland cryoablation.

The purpose of this observational research study is to investigate the localized treatment of prostate cancer using hemi-gland cryoablation. UCLA patients undergoing hemi-gland cryoablation are a unique cohort compared to prior research because all patients at UCLA have had a pre-treatment multi-parametric MRI and Ultrasound fusion targeted biopsy; they will be followed in a similar fashion. This results in more precise assessment of a target region of cancer for ablation which may, in turn, result in improved clinical outcomes.

Phase: Pilot/Feasibility
Gender: Male
Age Group: Adults
Contact: Merdie Delfin
Open Actively Recruiting

Graphical Representations of Symptoms of Prostate Cancer (GRASP): Preferences for Quality of Life Presentation among Underserved Prostate Cancer Patients

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Phase: N/A
Age Group: Adults
Contact: Sarah Connor
Open Actively Recruiting

99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer

This exploratory study conducted under the RDRC program studies the biodistribution of 99mTc-PSMA-I&S in patients with prostate cancer who undergo pelvic lymph node dissection. Prostate specific membrane antigen (PSMA)-targeted radio-guided surgery uses the preoperative intravenous administration of a PSMA-ligand called PSMA-imaging and surgery (I&S) labeled with the gamma-emitter radioisotope Technetium-99m (99mTc). Giving 99mTc-PSMA-I&S may detect PSMA-expressing lymph nodes during surgery using a gamma probe and may help guide doctors to detect prostate cancer that has spread to the lymph nodes.

Phase: Pilot/Feasibility
Primary Purpose: Basic Science
Gender: Male
Age Group: Adults
Contact: JEREMIE CALAIS
Open Actively Recruiting

International Registry for Men With Advanced Prostate Cancer (IRONMAN)

Our intent is to establish the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum 5,000 men with advanced cancer, including men with mHSPC and M0/M1 CRPC. The goal is to establish a population-based registry and recruit patients across academic and community practices from Australia, Brazil, Canada, Ireland, Jamaica, Nigeria, Norway, Spain, Sweden, Switzerland, the United Kingdom (UK), and the US. Target accrual number and number of participating sites are subject to change based on accrual, funding, and interest in participation by other international sites. This cohort study will facilitate a better understanding of the variation in care and treatment of advanced prostate cancer across countries and across academia and community based practices.

Detailed data will be collected from patients at study enrollment and then during follow-up, for a minimum of five years. Patients will be followed prospectively for overall survival, clinically significant adverse events, comorbidities, changes in cancer treatments, and PROMs. PROMs questionnaires will be collected at enrollment and every three months thereafter. Physician Questionnaires will be collected from all participating sites at patient enrollment, time of first change in treatment and/or one year follow-up, at each subsequent change of treatment, and discontinuation of treatment. As such, this registry will help identify the treatment sequences or combinations that optimize overall survival and PROMs for men with mHSPC and M0/M1 CRPC. By collecting blood at enrollment, time of first change in treatment and/or one year follow-up (plasma, cell free DNA, buffy coat / RNA), this registry will further identify and validate molecular phenotypes of disease that predict response and resistance to specific therapeutics. Additionally, every effort will be made to collect blood specimen at each subsequent change in treatment due to progression of disease. When feasible, existing tumor tissue may be collected for correlation with described blood based studies. All samples will be used for future research. This cohort study will provide the research community with a unique biorepository to identify biomarkers of treatment response and resistance.

Phase: N/A
Gender: Male
Age Group: Adults
Contact: Nazy Zomorodian
Open Actively Recruiting

Trial of ARV-110 in Patients With Metastatic Castration Resistant Prostate Cancer

Phase 1/2 dose escalation study to assess the safety and tolerability of ARV-110 in men with mCRPC who have progressed on prior approved systemic therapies for their castrate resistant disease (one of which must be enzalutamide or abiraterone).

Phase: Phase I/II
Primary Purpose: Treatment
Gender: Male
Age Group: Adults
Contact: KATHRYN B HILBURN
Investigator: John Shen, MD
Open Actively Recruiting

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 invasive techniques than what is currently used.

Phase: N/A
Gender: Male
Age Group: Adults
Investigator:
Kyung Hyn Sung
Open Actively Recruiting

Antiandrogen Therapy and SBRT in Treating Patients With Recurrent, Metastatic Prostate Cancer

This phase II trial studies how well antiandrogen therapy (leuprolide, apalutamide, and abiraterone acetate) and stereotactic body radiation therapy (SBRT) works in treating patients with prostate cancer that has come back and has spread to other parts of the body. Drugs used in chemotherapy, such as leuprolide, apalutamide, and abiraterone acetate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving antiandrogen therapy and SBRT may work better in treating patients with prostate cancer.

Phase: Phase II
Primary Purpose: Treatment
Gender: Male
Age Group: Adults
Open Actively Recruiting

Biopsy Tracking and MRI Fusion to Enhance Imaging of Cancer Within the Prostate

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Phase: N/A
Age Group: Adults
Contact: Merdie Delfin
Open Actively Recruiting

Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer

This is a Phase 1b/2, open-label, multicenter platform trial to evaluate the antitumor activity and safety of etrumadenant (AB928)-based combination therapy in participants with metastatic castrate resistant prostate cancer (mCRPC).

Phase: Phase I/II
Primary Purpose: Treatment
Gender: Male
Age Group: Adults
Contact: KATHRYN B HILBURN
Investigator: John Shen, MD
Open Actively Recruiting

Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation

This exploratory study investigates how a new imaging technique called FAPI PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with prostate cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors. The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers including prostate cancer.

Phase: Pilot/Feasibility
Primary Purpose: Basic Science
Gender: Male
Age Group: Adults
Contact: JEREMIE CALAIS
Open Actively Recruiting

Image-Guided (68Ga-PSMA-11 PET/CT) Prostate Biopsy for the Diagnosis of Prostate Cancer in Men With Prior Negative/Inconclusive Biopsy

This early phase I trial studies how well an image-guided prostate biopsy using the imaging agent 68Ga-prostate-specific membrane antigen (PSMA)-11 with a positron emission tomography/computed tomography (PET/CT) scan works in diagnosing prostate cancer in men with a prior negative or inconclusive prostate biopsy. PSMA is a protein that is found on the surface of prostate cancer cells. 68Ga-PSMA-11 is made up of a substance that binds to PSMA on tumor cells, linked with a radioactive substance that can then be seen on imaging scans such as PET/CT. 68Ga-PSMA-11 PET/CT-guided biopsy may help improve the detection rate of prostate cancer. This may help reduce over-diagnosis and over-treatment in men with low-risk prostate cancer and under-treatment in men with high-risk prostate cancer.

Phase: N/A
Primary Purpose: Diagnostic
Gender: Male
Age Group: Adults
Contact: WESLEY ARMSTRONG
Open Actively Recruiting

Trial of ARV-110 and Abiraterone in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

Phase 1b study to assess the combination of ARV-110 and abiraterone in patients with metastatic prostate cancer with PSA progression on abiraterone.

Phase: Phase I
Primary Purpose: Treatment
Gender: Male
Age Group: Adults
Contact: KATHRYN B HILBURN
Investigator: John Shen, MD
Open Actively Recruiting

Micro-Ultrasound for the Detection and Localization of Prostate Cancer Tumors in Patients Undergoing Radical Prostatectomy

This trial studies the ability of micro-ultrasound to detect and characterize prostate cancer tumors in patients undergoing radical prostatectomy (removal of the entire prostate and some of the tissue around it). Usually multiparametric magnetic resonance imaging is used for the detection and targeted therapy of prostate cancer, but its accuracy remains imperfect. Micro-ultrasound may be superior as it provides real-time tumor visualization which may simplify and improve prostate cancer targeted therapy. This may also reduce the need for and substantial costs of radical prostatectomy.

Phase: N/A
Primary Purpose: Diagnostic
Gender: Male
Age Group: Adults
Contact: Merdie Delfin
Open Actively Recruiting

Pivotal Study of MRI-guided Transurethral Ultrasound Ablation in Patients With Localized Prostate Cancer

MRI-guided Transurethral Ultrasound Ablation (MRI-TULSA) technology was developed at Sunnybrook Research Institute (Toronto, Canada), after several years of research and testing. Early feasibility testing in humans was conducted at Sunnybrook Research Institute by Dr. Laurence Klotz. In two separate studies, a total of twelve patients who were scheduled for prostatectomy volunteered for the MRI-TULSA prostate ablation procedure prior to their surgery. After the surgery, their prostate was removed and tested (histology) to confirm that prostate tissues were ablated as planned. The results showed that MRI-TULSA can precisely ablate prostate tissue [Chopra et. al. Radiology 2012, Volume 265, Number 1, pages 303-313].

Profound Medical Inc. has licensed exclusively the MRI-TULSA technology from Sunnybrook Research Institute and is developing it into a medical device named the TULSA-PRO. Recently, 30 patients went through this procedure in a Phase I clinical trial in the United States, Canada, and Germany. The purpose of the study was to assess safety of the TULSA-PRO system. All patients underwent the prostate ablation procedure and the study end points were met. The Phase I trial demonstrated that the TULSA-PRO system is safe and feasible and further study in a larger patient population is justified. The purpose of this study is to obtain information on the safety and effectiveness of the TULSA-PRO system. The system is designed to destroy prostate tissue under Magnetic Resonance Imaging (MRI) guidance using ultrasound energy. This device is not approved for clinical use except within this investigational study.

Phase: Phase II/III
Primary Purpose: Treatment
Gender: Male
Age Group: Adults
Investigator: Steven Raman, MD
Open Actively Recruiting

Human Prostate Stem Cells in Prostaspheres

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Phase: N/A
Age Group: Adults
Contact: JOYCE YAMASHIRO
Open Actively Recruiting

Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer

This phase III trial studies whether adding apalutamide to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may help stop or reduce the growth of prostate cancer cell growth by blocking the attachment of androgen to its receptors on cancer cells, a mechanism similar to stopping the entrance of a key into its lock. Adding apalutamide to the usual hormone therapy and radiation therapy after surgery may stabilize prostate cancer and prevent it from spreading and extend time without disease spreading compared to the usual approach.

Phase: Phase III
Primary Purpose: Treatment
Gender: Male
Age Group: Adults
Contact: Amar Kishan
Open Actively Recruiting

A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) as compared to placebo plus ADT.

Phase: Phase III
Primary Purpose: Treatment
Gender: Male
Age Group: Adults
Open Actively Recruiting

Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer With Rising PSA After Radical Prostatectomy

This phase II trial investigates the effect of extremely hypofractionated intensity modulated stereotactic body radiotherapy in treating patients with prostate cancer that has rising prostate specific antigen (PSA) after radical prostatectomy. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Phase: Phase II
Primary Purpose: Treatment
Gender: Male
Age Group: Adults
Contact: Annalise Stube