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Prostatic Neoplasms clinical trials

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NCT ID: NCT04873427 Terminated - Prostate Cancer Clinical Trials

In Situ Clonal Heterogeneity in Prostatic Diagnostic Biopsies

Start date: April 15, 2021
Phase:
Study type: Observational

This is a retrospective, proof of concept study, which aims at reconstructing the cellular heterogeneity of the tumor in multi-needle diagnostic prostate biopsy as well as any biopsy containing potentially pre-malignant tissue, to study its implications in the clinical history of the disease. For each patient, 2 or more samples will be prepared starting from the FFPE diagnostic material. The biopsy used for assigning the Gleason score will be sequenced, together with two or more of the local peri-proximal biopsies with a higher level of differentiation. Samples will undergo Whole Exome Sequencing with an average coverage of 300x at the Wellcome Sanger Institute (WSI, Hinxton, UK). Sequencing data will be analysed for single nucleotide variants, copy number variants and structural variants by using state-of-the-art data analysis pipeline at WSI. 1. Reconstruction of local PCa heterogeneity in multi-needle diagnostic biopsy with different Gleason scores (6-10) using high-coverage whole exome sequencing (WES) and DP-based clonal analysis; 2. Characterization of the relationships between pathological differentiation (Gleason score) and genomics-measured heterogeneity and malignancy features; 3. Assessment of clinical implications of clonal heterogeneity. The study will include an average of 150 prostatic diagnostic biopsies from a cohort of 20 early metastatic PC patients and 20 non-relapsing/non-metastatic patients with indolent malignant disease.

NCT ID: NCT04844749 Terminated - Clinical trials for Metastatic Castration-resistant Prostate Cancer

Efficacy Evaluation of VERU-111 for mCRPC in Patients Who Have Failed at Least One Androgen Receptor Targeting Agent

VERACITY
Start date: June 24, 2021
Phase: Phase 3
Study type: Interventional

To demonstrate the efficacy of VERU-111 (Sabizabulin) in the treatment of metastatic castration-resistant prostate cancer in patients who have failed prior treatment with at least one androgen receptor targeting agent as measured by radiographic progression-free survival.

NCT ID: NCT04737109 Terminated - Clinical trials for Castrate Resistant Prostate Cancer

Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men With Localized, High Risk Prostate Cancer

ADDItion
Start date: July 13, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This multicenter Phase I/II trial consists of two stages: a phase I stage in patients with castration resistant prostate cancer in which the recommended phase II dose will be determined for ipatasertib administered in combination with darolutamide; and a phase II neoadjuvant stage in which patients with high risk prostate cancer and loss of PI3K pathway activation in the tumor tissue planning on undergoing prostatectomy receive ADT, darolutamide, and ipatasertib for 24 weeks prior to planned surgery.

NCT ID: NCT04727736 Terminated - Prostate Cancer Clinical Trials

18F-DCFPyL Positron Emission Tomography (PET) in Intermediate or High Risk Prostate Cancer

Start date: May 1, 2021
Phase: Phase 2
Study type: Interventional

This is an interventional, single group assignment, prospective nonrandomized, open label Phase 2 trial designed to evaluate 18F-DCFPyL PET imaging in men diagnosed with prostate cancer with increasing prostate-specific antigen (PSA) levels.

NCT ID: NCT04727710 Terminated - Prostate Cancer Clinical Trials

Testing the Effect of Mindfulness for Prostatectomy Outcomes

TEMPO
Start date: August 26, 2020
Phase: N/A
Study type: Interventional

This research project has 2 parts: The first part of the research is to develop a couples-based group mindfulness intervention for men undergoing prostatectomy, with input from patients and their partners. The second part is the trial registered here, which will pilot the researchers' mindfulness intervention, developed in part 1, and observe any reduction of distress for men undergoing prostatectomy and their partners.

NCT ID: NCT04677855 Terminated - Prostate Cancer Clinical Trials

Study of PCUR-101 in Combination With ADT in Patients With mCRPC

Start date: March 30, 2021
Phase: Phase 1
Study type: Interventional

This is an open label, non-randomized, Phase I, dose escalation/dose expansion study in cohorts of patients with metastatic CRPC at Screening. Dose escalation uses a 3+3 design to determine the maximum tolerated dose (MTD). Once the MTD is defined, the dose expansion phase is used to define the recommended phase 2 dose.

NCT ID: NCT04634344 Terminated - Clinical trials for Metastatic Castration Resistant Prostate Cancer

Assess the Safety, Tolerability, PK and Anti-tumor Efficacy of DZD2269 in Patients With MCRPC

Start date: April 12, 2021
Phase: Phase 1
Study type: Interventional

This study will treat patients with Metastatic Castration Resistant Prostate Cancer who have progressed following prior therapy. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy.

NCT ID: NCT04631601 Terminated - Clinical trials for Metastatic Castration-resistant Prostate Cancer

Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC)

Start date: January 15, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a master protocol designed to evaluate the safety and efficacy of investigational therapies in participants with metastatic castration-resistant prostate cancer (mCRPC).

NCT ID: NCT04616547 Terminated - Clinical trials for Castration-Resistant Prostate Carcinoma

Treatment of Cancer-Related Bone Pain by Using Bone-Targeted Radiation-Based Therapy (Sn-117m-DTPA) in Patients With Prostate Cancer That Has Spread to Bones

Start date: December 18, 2021
Phase: Phase 2
Study type: Interventional

This phase II trial studies the effect of Sn-117m-DTPA on bone pain in patients with prostate cancer that has spread to the bones. Sn-117m-DTPA is a radioactive therapeutic agent that localizes to bones when given to patients. Sn-117m-DTPA may help reduce bone pain in patients with prostate cancer that has spread to the bones.

NCT ID: NCT04615845 Terminated - Clinical trials for Castration Resistant Prostate Cancer, CRPC

Safety Evaluation of Autologous Dendritic Cell Anticancer Immune Cell Therapy (Cellgram-DC-PC)

Start date: June 21, 2021
Phase: Phase 1
Study type: Interventional

This Phase 1 study to evaluate the safety of cancer immunotherapy with autologous dendritic cells(DC) in patients with metastatic castration resistant prostate cancer (mCRPC)