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Prostatic Neoplasms clinical trials

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NCT ID: NCT06014255 Recruiting - Prostate Cancer Clinical Trials

Trial of Neoadjuvant Enoblituzumab vs SOC in Men With High-Risk Localized Prostate Cancer

HEAT
Start date: February 16, 2024
Phase: Phase 2
Study type: Interventional

This study evaluates the efficacy, anti-tumor effect, and immunogenicity of neoadjuvant enoblituzumab given before radical prostatectomy. Patients will be randomized to enoblituzumab for a total of 12 weeks beginning 84 days before radical prostatectomy or standard of care arms.

NCT ID: NCT06011304 Recruiting - Prostate Cancer Clinical Trials

Study of 18F-Florastamin PET/CT Imaging in Patients With at Least Intermediate Risk Prostate Cancer

Start date: October 20, 2023
Phase: Phase 3
Study type: Interventional

In this study, 18F-Florastamin PET/CT will be performed in patients with at least intermediate risk prostate cancer, to assess the diagnostic performance and safety of 18F-Florastamin PET/CT imaging. This study will first carry out the pilot study (including pharmacokinetics and radiation dosimetry).

NCT ID: NCT06010914 Recruiting - Clinical trials for Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

A Study to Learn More About How Safe Darolutamide is Under Real-world Conditions in Participants With Metastatic Hormone-Sensitive Prostate Cancer

DADOX
Start date: October 9, 2023
Phase:
Study type: Observational

This is an observational study in which only data are collected from participants receiving their usual treatment. In this study, data will be collected and studied from men with metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer is a common cancer in men that starts in the prostate gland, a male reproductive gland found below the bladder. Metastatic means that the cancer has spread to other parts of the body. Hormone-sensitive means it can be treated with hormone-therapy such as androgen deprivation therapy (ADT). ADT lowers the level of testosterone, a male hormone, and slows down the growth of cancer cells. Men with mHSPC and who have been decided by their own doctors to be treated with darolutamide in combination with ADT and docetaxel can join this study. Darolutamide works by blocking the testosterone signals to slow the growth of the cancer cells. Docetaxel is a medicine used to treat different types of cancer. It works by stopping the growth and spread of cancer cells. Darolutamide in combination with docetaxel and ADT is an approved treatment for men with mHSPC. It was approved based on a study called ARASENS. More information is needed on how safe darolutamide is when given with ADT and docetaxel in Japanese men with mHSPC. The main purpose of this study is to collect information about the safety of this combination treatment in Japanese participants with mHSPC under real-world conditions. The main information that researchers will collect: Number and severity of heart-related medical problems participants have during the treatment Other information that researchers will collect: Number and severity of all medical problems participants have during the study Age and other information about the participants such as their illness, medical history, and other medicines taken at the same time Treatment pattern of darolutamide such as the amount of medicine given, the duration for which it is given, and any changes made to the treatment Data will be collected from August 2023 to July 2026. Researchers will observe participants from the start of darolutamide treatment until 30 days after they receive their last dose of docetaxel, which is expected to be approximately 6 months for each participant. In this study, data from regular health visits will be collected. No visits or tests are required as part of this study.

NCT ID: NCT06004661 Recruiting - Clinical trials for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function

Start date: April 4, 2024
Phase: Phase 2
Study type: Interventional

This study will address health authorities' requests to determine whether moderate and severe renal impairment have an impact on the biodistribution, dosimetry and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) administered to participants with progressive PSMA-positive metastatic castration-resistant prostate cancer. The study will also characterize the risk of QT prolongation of AAA617 in this participant population.

NCT ID: NCT06003556 Recruiting - Prostate Cancer Clinical Trials

PSMA-Guided Ablation of the Prostate

P-GAP
Start date: April 2, 2024
Phase: Phase 2
Study type: Interventional

The goal of this phase 2 multicenter randomized controlled trial is to study the accuracy of second generation prostate specific membrane antigen (PSMA) positron emission tomography (PET; utilizing 18F-PSMA-1007) compared to standard of care multiparametric MRI and MRI targeted-prostate biopsy for staging in patients diagnosed with unilateral prostate cancer who are eligible for focal therapy. The main question it aims to answer is: Can PSMA PET improve diagnostic accuracy for the primary staging of Prostate Cancer for patients undergoing focal therapy thereby reducing residual and recurrence disease? Participants who are eligible by current standard of care diagnostic workup will undergo 1:1 randomization to PSMA PET scan or no further imaging. Those diagnosed with bilateral disease by PSMA PET will be ineligible for focal therapy and be referred for radical therapy. Men with unilateral disease on PSMA PET and those randomized to no further imaging will then undergo focal therapy. All men undergoing focal therapy will receive PSMA PET, MRI, and combined targeted and systematic biopsy 12 months after ablation. The primary outcome will be the detection of Gleason Grade Group 2 or higher prostate cancer in men 12 months after hemigland ablation.

NCT ID: NCT06001255 Recruiting - Clinical trials for Metastasis Castration Resistant Prostate Cancer(mCRPC)

ARTEMIS-003: HS-20093 in Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC)

Start date: January 18, 2024
Phase: Phase 2
Study type: Interventional

HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the anti-tumor activity, safety and pharmacokinetics of HS-20093 in Chinese patients with metastasis Castration Resistant Prostate Cancer. This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) of HS-20093 as a monotherapy in subjects with metastasis castration resistant prostate cancers (mCRPC) and other solid tumors.

NCT ID: NCT05997615 Recruiting - Clinical trials for Hormone-refractory Prostate Cancer

Safety, Pharmacokinetics, and Preliminary Efficacy of AMX-500 in Metastatic Castration Resistant Prostate Cancer (mCRPC)

Start date: August 10, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The study will be conducted in 4 parts and will commence with dose escalation of AMX-500 as a monotherapy (Part 1), followed by monotherapy dose expansion (Part 2). - Part 1 (Monotherapy Dose Escalation): Single-agent AMX-500 dose escalation - Part 2 (Monotherapy Dose Expansion): Single-agent AMX-500 dose expansion The study may subsequently continue via a protocol amendment with dose escalation of AMX-500 combinations (Part 3) followed by combination therapy dose expansion (Part 4).

NCT ID: NCT05996289 Recruiting - Prostate Cancer Clinical Trials

Inter-observer Variability in the Segmentation of Prostate Tumour Lesions Using Multiparametric MRI (VARIOP)

VARIOP
Start date: August 1, 2023
Phase:
Study type: Observational

Following the major technological and scientific advances in external radiotherapy in recent decades, thanks to the use of three-dimensional conformal techniques combined with intensity modulation, image-guided radiotherapy has enabled radiotherapists to increase doses without increasing sequelae and complications, giving rise to the term "dose escalation". Following multiple dose-escalation clinical trials showing better biological control of PSA, the results of the latest phase 3 FLAME trial incorporated the notion of intraprostatic boost in relation to the primary prostate lesion, considered to be the preferred site of neoplastic recurrence in prostate cancer. This leads to the first question, which concerns the identification of the dominant lesion and its precise delimitation. This last point is subject to variation between operators. A retrospective cohort from the Finistère region will therefore be used to develop a number of study points relating to : inter-operator contour variability - Factors influencing contour - Impact of contour variability on dosimetry - Automatic segmentation

NCT ID: NCT05995236 Recruiting - Prostate Cancer Clinical Trials

Prostate-Specific Membrane Antigen (PSMA) Radionuclide Therapy

Start date: August 2, 2023
Phase:
Study type: Observational

This study is a single-center registry study collecting clinical data regarding the treatment of PSMA-positive metastatic castration-resistant prostate cancer treated with PSMA radionuclide therapy per the treating physician's discretion. Clinical data from candidates for or who undergo the PSMA procedure at Methodist Dallas Medical Center from August 2022 to August 2027 will be collected after discharge and patients will undergo clinical follow-up per the treating physician's discretion.

NCT ID: NCT05983783 Recruiting - Chemotherapy Effect Clinical Trials

Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the mHSPC

Start date: August 1, 2023
Phase: Phase 3
Study type: Interventional

Evaluate whether the combination of Rezvilutamide and androgen deprivation therapy (ADT) with docetaxel improves overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to the combination of Rezvilutamide and ADT.