Active clinical trials for "Prostatic Neoplasms"

This Phase II trial will enroll approximately 180 adult male patients with an earlier histologic diagnosis of prostatic adenocarcinoma and a biochemical recurrence (BCR) within 3 years of radical prostatectomy (RP) or definitive RT and no distant metastasis or locoregional recurrence. The trial is a randomized placebo-controlled double-blind study of a peptide cancer vaccine (RV001V).

The primary objective of this study is to evaluate the safety and feasibility of Magnetic-Resonance(MR)-ultrasound image fusion-guided transrectal-based focal laser ablation (FLA) of prostate cancer using the Orion System, an investigational laser-based interstitial irradiation/thermal soft-tissue ablation system. Safety and feasibility will be determined by analyzing the number, type, and severity of adverse events.

The aim is to define the postponement of next line systemic treatment (NEST), by the use of metastasis-directed therapy in patients with oligoprogressive castration-refractory prostate cancer. This will be defined by the NEST-free survival. Furthermore the investigators will use 18F PSMA PET-CT as investigational imaging, to assess the predictive value and impact on treatment policy.

Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT. 5-fraction SABR is a feasible, well-tolerated, effective and cost effective treatment for high-intermediate and high risk prostate cancer with/without an image-guided intraprostatic boost.

The primary objective is to determine the safety and activity of combined hormonal chemoimmunotherapy in a single-arm phase II trial of REGN2810, androgen deprivation therapy (ADT), and docetaxel in patients with newly metastatic, hormone-sensitive prostate cancer (mHSPC), using a primary endpoint of undetectable prostate-specific antigen (PSA) at 6 months, defined from start of combination therapy (week 10) until 6 months (week 37).

This phase III study provides access to 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) imaging for patients with castrate-resistant prostate cancer that has spread to other places in the body (metastatic) being considered for177Lu-PSMA-617 therapy. T PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of this tracer. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Combining a PET scan with a CT scan can help make the images easier to interpret. The 68Ga-PSMA-11 PET/CT scan is done with a very small amount of radioactive tracer call 68- gallium PSMA-11. In patients that have been diagnosed with prostate cancer, a protein called prostate-specific membrane antigen (PSMA) appears in large amounts on the surface of the cancerous cells. The radioactive imaging agent (68Ga-PSMA-11) has been designed to circulate through the body and attach itself to the PSMA protein on prostate cancer cells. A PET/CT scan is then used to detect the location of prostate cancer lesions. By gaining access to 68Ga-PSMA-11 PET/CT scans, patients may be safely screened for 177Lu-PSMA-617 therapy in the treatment of metastatic castrate resistant prostate cancer.

This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus ADT versus placebo plus enzalutamide plus ADT in Chinese participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS). As of Amendment 4, the study is being stopped for futility. All the prespecified interim analyses after interim analysis 1 (IA1) and final analysis of the study described in the statistical analysis plan (SAP) will not be performed. Safety analysis will be performed at the end of the study; there will be no further analyses for efficacy and electronic patient-reported outcome (ePRO) endpoints collected from participants beyond the IA1 cutoff date. All study participants will stop ongoing treatment with pembrolizumab/placebo. Exceptions may be requested for study participants who, in the assessment of their study physician, are benefitting from the combination of enzalutamide and pembrolizumab, after consulting with the Sponsor. All other study participants should be discontinued from study and be offered standard of care (SOC) treatment as deemed necessary by the Investigator. If enzalutamide as SOC is not accessible off study to the participant, central sourcing may continue. As of Amendment 04, disease progression will no longer be centrally verified, participants will only be assessed locally. As of Amendment 4, Second Course treatment is not an option for participants. There are currently no participants in the Second Course Phase.

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

This phase I/II trial tests the safety, side effects, and best dose of abemaciclib and whether it works before 177Lu-PSMA-617 in treating patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abemaciclib is in a class of medications called kinase inhibitors. It is highly selective inhibitors of cyclin-dependent kinase 4 and 6, which are proteins involved in cell differentiation and growth. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. Radioligand therapy uses a small molecule (in this case 177Lu-PSMA-617), which carries a radioactive component to destroys tumor cells. When 177Lu-PSMA-617 is injected into the body, it attaches to the prostate-specific membrane antigen (PSMA) receptor found on tumor cells. After 177Lu-PSMA-617 attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving abemaciclib before 177Lu-PSMA-617 may help 177Lu-PSMA-617 kill more tumor cells.

Men with localized prostate cancer (PCa) are often treated with surgery, a treatment that is associated with high rates of side effects such as erectile dysfunction (ED) and urinary incontinence (UI) which impact quality of life. Yoga may improve control of UI and improve ED by bringing awareness to and strengthening the pelvic floor musculature. The randomized controlled pilot study is to assess the feasibility of an innovative hybrid (in-person and virtual) twice-weekly yoga program that includes a prehabilitation component and to obtain preliminary data that will help assess its potential effectiveness in alleviating PCa treatment symptom burden (primarily ED and UI). The long-term goal is to develop a scalable and sustainable yoga program that helps cancer survivors manage their treatment side effects.