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Prostatic Neoplasms clinical trials

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NCT ID: NCT05081193 Not yet recruiting - Prostate Cancer Clinical Trials

Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrate Resistant Prostate Cancer

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

Previous studies of high dose testosterone therapy given intramuscularly to men with metastatic castrate resistant prostate cancer suggest that high serum levels of testosterone may be required for clinical response. This injection regimen was given as one dose of 400mg injection every 28 days, which initially produces high serum testosterone levels but these levels drop to a varying degree in some men over the 28-day cycle. In this 30 patient trial will analyze the effects of oral testosterone therapy in men with metastatic castrate resistant prostate cancer taken on a schedule of seven days of oral testosterone therapy followed by seven days of no therapy for a twenty-eight day cycle. This therapy will be given for three 28 day cycles consecutively followed by radiographic scans to evaluate the metastatic disease. Patients will be allowed to continue on this therapy until the patients show signs of radiographic progression. If the patients show signs of radiographic progression after the first three cycles, the patients will stop taking the oral testosterone therapy and begin taking enzalutamide therapy. Enzalutamide therapy will be taken for three 28 day cycles, then radiographic scans will be taken. If there are no signs of radiographic progression, patients can continue to take enzalutamide therapy for an additional 3 cycles while on study. Patients with continued PSA or objective response will come off study but continue on enzalutamide as standard of care therapy. This study will help the investigators to understand if treating these men with the highest FDA approved dose of oral testosterone therapy will achieve similar and sustained high levels of serum testosterone that will produce similar or enhanced therapeutic response to the therapy when compared to the serum testosterone levels found in the previous injection therapy trials.

NCT ID: NCT05079828 Not yet recruiting - Prostate Cancer Clinical Trials

Head-to-head Comparison of 68Ga-PSMA-11 and 18F-PSMA-1007

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

The aim of this study is to provide robust data on the head-to-head comparison of the two ligands of the prostate specific membrane antigen (PSMA) available in Switzerland for positron emission tomography (PET)-imaging, i.e. 68Ga-PSMA-11 und 18F-PSMA-1007.

NCT ID: NCT05079698 Recruiting - Prostate Cancer Clinical Trials

A Study of Stereotactic Body Radiotherapy and 177Lu-PSMA-617 for the Treatment of Prostate Cancer

Start date: October 1, 2021
Phase: Phase 1
Study type: Interventional

The researchers are doing this study to find out whether combining 177Lu-PSMA-617 with SBRT is a safe and effective treatment in people who have hormone-sensitive oligometastatic prostate cancer. The researchers also want to learn more about how the study treatment affects daily life and the symptoms of cancer. This study is the first to test the combination of 177Lu-PSMA-617 and SBRT in people.

NCT ID: NCT05078359 Enrolling by invitation - Prostate Cancer Clinical Trials

Optimizing Positive Predicting Value of Prostate MRI

PROMOD
Start date: January 1, 2020
Phase:
Study type: Observational

The PROMOD study is an international multicenter retrospective Project. The aim is to create a comprehensive database that will include multiple heterogeneous cohorts in order to explore inter-center differences in the accuracy of Magnetic Resonance Imaging (MRI) in the diagnosis of prostate cancer and to define optimal strategies for the selection of men at risk of clinically significant prostate cancer who might benefit from biopsies.

NCT ID: NCT05078151 Recruiting - Clinical trials for Prostate Cancer Metastatic

Whole-Body Diffusion-Weighted Magnetic Resonance Imaging (MRI) as a Response Biomarker for Metastatic Prostate Cancer

iPROMET
Start date: September 1, 2018
Phase: N/A
Study type: Interventional

The skeleton is the most frequent organ of distal metastases in prostate cancer, often representing the only site of metastatic disease. Still, assessment of response and progression to therapies in bone metastases remains a major unmet need, to aid treatment switch decisions, detecting primary/secondary resistance and to optimize drug development. The currently used standard imaging techniques, computed tomography (CT) and bone scintigraphy (BS), do not depict the true extent of bone metastases and are suboptimal in capturing biological changes occurring in response to treatment. This results in treatment switch decisions too often being based on PSA changes, which is neither a surrogate of survival, nor an optimal response biomarker.Diffusion-weighted imaging (DWI) is a functional magnetic resonance imaging (MRI) technique that studies the movement of water molecules within a tissue and provides valuable information about the tissue microstructure and cellularity. Whole body MRI with DWI is highly accurate for bone metastases detection, outperforming the standard CT and BS and other imaging techniques when assessing bone metastases. The investigators hypothesise that DWI changes are a response biomarker in bone metastases from metastatic castration resistant prostate cancer (mCRPC); these DWI changes can be detected as early as after 4 weeks of systemic treatment.

NCT ID: NCT05077098 Recruiting - Clinical trials for Recurrent Prostate Cancer

Study of ADXS-504 Immunotherapy for Recurrent Prostate Cancer

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

Primary: • To evaluate the safety and tolerability of ADXS-504 and to determine the MTD or RP2D.

NCT ID: NCT05076851 Recruiting - Clinical trials for Neoadjuvant Therapy \High Risk Prostate Cancer

Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy(ADT)for High Risk Prostate Cancer

Start date: June 17, 2021
Phase: Phase 2
Study type: Interventional

This trial aims to evaluate the efficacy and safety of neoadjuvant therapy with Proxalutamide combined with androgen deprivation therapy(ADT)for High risk prostate cancer ,This trial is A randomized, controlled, double-blind, single center.Treatment cycle is 6 months,

NCT ID: NCT05075577 Recruiting - Prostate Cancer Clinical Trials

EPI-7386 in Combination With Enzalutamide Compared With Enzalutamide Alone in Subjects With mCRPC

Start date: October 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2 study of EPI-7386 orally administered in combination with enzalutamide in subjects with mCRPC. Phase 1 of the study will be a single-arm dose escalation study of EPI-7386 in combination with a fixed dose of enzalutamide. This portion of the study will primarily evaluate the safety and tolerability of the drug combination and establish the RP2CDs for EPI-7386 and enzalutamide when dosed in combination. In addition, blood sampling will be conducted for PK evaluation to assess the potential DDI between the two drugs. Once the RP2CD for each drug has been established, Phase 2 of the study will commence. Phase 2 is a two-arm, randomized (2:1), open-label study. Approximately 120 subjects will be randomized 2:1 to: - Group 1: EPI-7386 at the RP2CD + enzalutamide(depending on the results of the Phase 1) (n=80) - Group 2: Enzalutamide single agent (n=40) The planned dose of enzalutamide and EPI-7386 for the combination arm will be those determined in the Phase 1 of this study based on safety and exposure data. Subjects may remain on study treatment as long as they are tolerating treatment without disease progression based on RECIST v1.1 and/or PCWG3.

NCT ID: NCT05073653 Recruiting - Prostate Cancer Clinical Trials

A Study of 68Ga-GRP PET/CT for Imaging in Low and Intermediate Risk Prostate Cancer

Start date: October 11, 2021
Phase: N/A
Study type: Interventional

Patients with primary low and intermediate risk prostate cancer (PCa) for whom radical prostatectomy are indicated, will be invited to participate to the present study. The aim of this study is to investigate the clinical value of 68Ga-GRP positron emission tomography / computed tomography (PET/CT) compared to 68Ga-PSMA PET/CT in patients with low and intermediate risk PCa.

NCT ID: NCT05069584 Not yet recruiting - Prostate Cancer Clinical Trials

TransPERineal Fusion Biopsy Versus transrECTal

PERFECT
Start date: October 2021
Phase: N/A
Study type: Interventional

Comparison of the efficacy and safety of 2 types of prostatic biopsies: transperineal biopsy versus transrectal biopsy.