Study Using TNB-585/AMG 340 (Bispecific Antibody Therapy) to treat men with mCRPC

Organization: AMGEN

NCT04740034

Patient Summary: This study evaluates safety and the performance of AMG 340 in men with metastatic castrate-resistant prostate cancer (mCRPC). TNB-585 is a novel bispecific antibody, which binds to PSMA on prostate cancer cells and the CD3 molecule on T-cells (immune cell). It is used to treat men with mCRPC who have received 2 or more other forms therapy.

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Study of AMG 509 in Subjects with Metastatic Castration-Resistant Prostate Cancer

Organization: AMGEN

NCT04740034

Patient Summary: This clinical trial is for patients who have metastatic castration resistant prostate cancer (mCRPC) and failed to respond to abiraterone acetate or enzalutamide (but not both) and to taxane-based chemotherapy.   This study is investigating the safety and effects (good or bad) of using AMG 509 to treat prostate cancer, which spread to other parts of the body and is resistant to chemo-hormonal therapies.  AMG 509 is an immuno-oncology treatment that may help limit a cancer cell’s ability to grow.  AMG 509 attaches to the patient’s T cells and the prostate cancer cells, with the goal of putting the T cells directly in contact with the prostate cancer cell.

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A Study of AMG 757 bispecific antibody therapy in men with Neuroendocrine Prostate Cancer (NEPC)

Organization: Amgen

NCT04702737

Patient Summary: This study evaluates the safety and the maximum dose that can be handled by patients in this trial.  AMG 757 (tarlatamab) is a half-life extended bispecific T cell engager (HLE BITE®) immuno-oncology therapy that consists of a bispecific antibody that targets DLL3 (Delta-Like Ligand 3). DLL3 is a cell membrane protein that is expressed on the surface of some cancer cells. Tarlatamab helps the patient’s own T cells detect and kill prostate cancer cells that express DLL3.

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The AMPLITUDE study is looking for men with newly diagnosed metastatic prostate cancer.

Organization: Janssen

NCT04497844

Patient Summary: The AMPLITUDE study is looking at the effectiveness and safety of an investigational combination of medications compared with a standard prostate cancer therapy. The study is double-blind which means neither you nor your study doctor will know which medication you will be receiving during the trial.

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The Use of P-PSMA-101 CAR-T Cells to Threat Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients

Organization: Poseida Therapeutics

NCT0424997

Patient Summary: This clinical trial is for patients with metastatic castration-resistant prostate cancer (mCRPC) that has worsened despite having received hormonal and chemotherapeutic treatments.  This study investigates the safety and effects (good or bad) of using P-PSMA-101-001 to treat metastatic castration-resistant prostate cancer (mCRPC), which has spread to other parts of the body and is resistant to standard hormonal therapies.  P-PSMA-101 is a new immunotherapy called a CAR-T, which is made from the patient's white blood cells. P-PSMA-101 interacts with prostate surface membrane antigen (PSMA), protein commonly located on the surface of prostate cancer cells.

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A Study to evaluate the radioligand 177Lu-PSMA-617 in patients with naïve or minimally treated PSMA-positive metastatic hormone sensitive prostate cancer (mHSPC)

Organization: Novartis

NCT047201527

Patient Summary: The primary objective of this study is to evaluate radiographic progression free survival (rPFS) in patients with mHSPC receiving Standard of Care and 177Lu-PSMA-617 (Pluvicto) versus patients receiving Standard of Care without Pluvicto.  In this international, open-label, prospective, phase III study, with naïve or minimally treated mHSPC will be randomized in a 1:1 ratio to receive Standard of Care (SoC) with or without the radioligand Pluvicto. In this study, the combination for Androgen Receptor Directed Therapy (ARDT) + Androgen Deprivation Therapy (ADT) are allowed as SoC.

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

Organization: Novartis

NCT04689828

Patient Summary: The purpose of this study is to determine whether Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) improves the radiographic progression free survival (rPFS) or death compared to a change in androgen receptor-directed therapy (ARDT) in metastatic castration resistant prostate cancer (mCRPC) men that were previously treated with an alternate ARDT but did not receive a taxane-containing therapy for the treatment of CRPC or mHSPC. The clinical trial objective is to determine whether treatment with Pluvicto will slow or stop the progression prostate cancer in men with progressive PSMA-positive mCRPC compared to participants treated with ARDT.

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This trial is for male patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed following treatment with androgen receptor axis-targeted therapy (ARAT) but who haven't yet received chemotherapy for mCRPC.

Organization: POINT Biopharma

NCT04647526

SPLASH Patient Summary: The purpose of this trial is to evaluate the efficacy and safety of 177-Lu-PNT2002 in patients with mCRPC who have progressed following treatment with androgen receptor axis-targeted therapy (ARAT), such as Abiraterone or Enzalutamide, but who haven't yet received chemotherapy for mCRPC. During the trial, all participants will be treated with either 177-Lu-PNT2002 or with the current standard of care therapy. Everyone receives active treatment in this study. There is no placebo (inactive treatment).

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The PROTEUS study is a randomized, double-blind, placebo-controlled, phase 3 Study of an investigational drug in subjects with high-risk, localized or locally advanced prostate cancer who are candidates for radical prostatectomy.

Organization: Janssen

NCT03767244

Patient Summary: In the PROTEUS research study, doctors want to learn more about an investigational medicine that is taken with hormone therapy and given before and after a prostatectomy. They want to see if it is safe and if it is effective and helps prevent cancer from spreading when given to high-risk prostate cancer patients who choose prostate removal surgery as their treatment option.  All participants in this study will receive androgen deprivation therapy (ADT), which is used to reduce male hormone levels and stop them from affecting prostate cancer cells.

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This trial is for people with metastatic castration-sensitive prostate cancer (mCSPC) and DNA damage repair (DDR) gene alteration.

Organization: Pfizer

NCT04821622

Patient Summary: The purpose of TALAPRO-3 is to learn if talazoparib (the study medicine) is safe, and if the combination of talazoparib plus enzalutamide (an approved treatment for prostate cancer) is more effective than enzalutamide alone.  Participants in this study will be randomly assigned to 2 treatment groups. Half of participants will receive enzalutamide and talazoparib (the study drug), and the other half will receive enzalutamide and a placebo (tablet with no active ingredient). All participants in this study will need to take about 6 capsules by mouth once a day and attend at least 25 clinic visits over about 3 years.

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