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Prostatic Neoplasms clinical trials

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NCT ID: NCT05828082 Recruiting - Clinical trials for Refractory Prostate Carcinoma

Testing the Effect of M1774 on Hard-to-Treat Refractory SPOP-mutant Prostate Cancer

Start date: October 16, 2023
Phase: Phase 2
Study type: Interventional

This phase II trial tests how well M1774 works in treating patients with prostate cancer that does not respond to treatment (refractory) and that has a mutation in the gene responsible for making the speckle type BTB/POZ protein (SPOP). M1774 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving M1774 may be able to shrink or stabilize refractory SPOP-mutant prostate cancer.

NCT ID: NCT05826509 Recruiting - Prostate Cancer Clinical Trials

SUrGery With or Without dARolutamide in High-risk and/or Locally Advanced Prostate Cancer

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

This is a phase II, multicenter, randomized open-label and comparative trial designed to study the effectiveness and the safety of androgen receptor antagonist (darolutamide) combined with surgery in patients with high-risk and/or locally advanced prostate cancer. In this trial, patients will be assigned in one of the two following treatments arms: - Arm A (control arm): Surgery alone (radical prostatectomy with lymph node dissection) - Arm B (experimental arm): Peri-operative darolutamide + surgery (radical prostatectomy with lymph node dissection) A total of 240 patients will have to be randomized with 120 patients in the control arm and 120 patients in the experimental arm.

NCT ID: NCT05826470 Recruiting - Prostate Cancer Clinical Trials

Investigator Initiated Trial to Further Evaluate the Safety and Efficacy of Trans-perineal Focal Laser Ablation of Localized Prostate Cancer Using High Frequency Micro-ultrasound Imaging

Start date: May 30, 2023
Phase: N/A
Study type: Interventional

Trans-perineal focal laser ablation represents a promising alternative focal therapy option for patients with low-risk or favorable intermediate risk prostate cancer. FLA has been extensively utilized for over a decade in the treatment of PCa using different anatomical approaches. The proposed study differs from past ones in that a trans-perineal approach with reduced risk of infection will be used in contrast to the current trans-rectal approach. In addition, high frequency micro-ultrasound imaging will be used to enhance imaging and facilitate accurate needle placement and FLA of the index lesions. The aim of this study is to evaluate FLA as a potential optimal therapeutic intervention based on safety, ease of use, efficacy, and cost.1 FLA holds promise for the management of localized tumors. The combination of the trans-perineal focal laser ablation and micro-ultrasound imaging will enable targeted trans-perineal fusion laser induced thermal therapy of prostate cancer lesions. This approach offers significant potential advantages over traditional interventions including: - Improved dynamic ultrasound imaging of the lesion to be treated compared to traditional ultrasound techniques. - Enhanced ability to visualize and spare critical structures within the prostate, including the bladder neck, neurovascular bundle (NVB), urethral sphincter and organs in close proximity including the rectum. - Sparing these structures should translate into improved preservation of ejaculation, limited changes in sexual function and minimal transient incontinence following treatment.

NCT ID: NCT05823402 Recruiting - Clinical trials for Metastatic Castration-resistant Prostate Cancer

Use of SPECT-CT for Comparison of Dosimetry Methods in PSMA-targeted Radioligand Therapy (SPECTacular Study)

SPECTacular
Start date: May 1, 2023
Phase: N/A
Study type: Interventional

The SPECTacular study will enroll patients who are already undergoing a FDA approved PSMA-targeted Radioligand treatment cycle. During each treatment cycle, patients will receive 5 additional SPECT/CT scans to investigate the limits of agreement between dosimetry (absorbed radiation dose) approximation methods and dosimetry using the triexponential fitting method.

NCT ID: NCT05822726 Recruiting - Prostate Cancer Clinical Trials

The Combination of PSMA-PET/MR and p2PSA in Early Diagnosis of Prostate Cancer

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

This is a single center prospective non-randomized controlled study. The goal of this clinical trial is to figure out whether the combination of PSMA-PET/MR and PHI could add values to each method alone. The main questions it aims to answer are: - Compare the diagnostic value of the combination with each alone and set up a diagnostic model. - Compare the diagnostic value of PSMA-PET/MR+PHI to mpMRI+PHI. - Evaluate the diagnostic value the combination of PHI and PSMA-PET/MR in suspected PCA patients. Patients will experience mpMRI or PSMA-PET/MR and their blood samples will be used to test PSA and p2PSA. Prostate biopsy will be the golden standard.

NCT ID: NCT05820932 Recruiting - Prostate Cancer Clinical Trials

Predicting Cognitive Decline From Androgen Deprivation Therapy

ABC
Start date: May 22, 2023
Phase:
Study type: Observational

Androgen Deprivation Therapy (ADT) is associated with cognitive impairment and dementia in men with prostate cancer. Pre-clinical data suggest that ADT-induced hypogonadism leads to accumulation of beta-amyloid plaques in the hippocampus, a pathological hallmark of Alzheimer's Disease (AD). Neuroimaging Functional magnetic resonance imaging (fMRI) studies also demonstrate that ADT decreases metabolic activity in the parietal, occipital, and prefrontal cortices. Multiple prospective cohort and population-based clinical studies have been conducted to test the association between ADT and cognitive impairment and/or dementia. Plasma biomarkers have been developed to predict brain amyloidosis, a key pathological feature of AD and a risk factor for developing dementia due to AD. The advantage of a blood-based assay is the lower cost, invasiveness, and time compared to cerebrospinal fluid (CSF) and Positron Emission Tomography (PET)-based biomarkers.

NCT ID: NCT05820633 Recruiting - Prostate Cancer Clinical Trials

Pelvic Nodes Ultra-Hypo vs Conventionally Fractionated IMRT With HDR Boost in Prostate Cancer.

PCS-XI
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Randomized Phase III study, comparing pelvic ultra-hypo fractionated radiotherapy (UHF: 5Gy/fraction) to a standard or moderate hypo-fractionation (1.8-2.15Gy/fraction), both associated to an HDR prostate +/- adjacent seminal vesicles brachytherapy boost (HDR-BT)+ ADT according to NCCN guidelines. Considering that the calculated bio-equivalent doses to the tumor are similar for all treatment options, the UHF technique is deemed to be non-inferior to the standard approach. Treatment acceptability, tolerance and adverse events will be reported and compared for non-inferiority as the primary objective. Secondary objectives are biochemical control, metastasis-free, disease specific and overall survival.

NCT ID: NCT05818683 Recruiting - Clinical trials for Metastatic Castration-resistant Prostate Neoplasms

A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Castration-Resistant Prostate Cancer

Start date: April 26, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of JNJ-78278343 and combination agent in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of JNJ-78278343 with the combination agent in Part 2 (dose expansion).

NCT ID: NCT05818631 Recruiting - Prostate Cancer Clinical Trials

Cognitive Fusion Prostate Biopsy With Biparametric Magnetic Resonance in the Detection of Prostate Cancer

Start date: March 1, 2021
Phase:
Study type: Observational

The goal of this prospective observational study is to evaluate the diagnostic precision of the Biparametric Magnetic Resonance Imaging (bpMRI) in the detection of clinically significant prostate cancer (PCa) in patients with biochemical suspicion of prostate cancer with PSA (Prostate Specific Antigen) > 4 ng/mL and a normal digital rectal examination and without a biopsy previous to the MRI. Secondary aims are: - Determine the validity as a diagnostic test of the first directed transrectal prostatic biopsy (cognitive fusion) versus systematic biopsy of 12 cylinders in patients with suspicious lesions in the bpMRI. - Develop a predictive nomogram that permits the reduction of the number of prostatic biopsies performed to patients with a low suspicion of prostate cancer in the bpMRI.

NCT ID: NCT05815394 Recruiting - Prostate Cancer Clinical Trials

177Lu-labeled NY108 SPECT Imaging in Patients

Start date: March 3, 2023
Phase: Early Phase 1
Study type: Interventional

This is a single arm study to evaluate the safety and biodistribution of 177Lu-labeled NY108 (177Lu-NY108) SPECT Imaging in patients.