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Metastatic Prostate Cancer - ClinicalTrials.gov

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Last Updated: 27 June 2022

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An Open-Label, Phase 1/1b, Study of ORIC-944 in Patients With Metastatic Prostate Cancer

Following an interval 3+3 design, the study will begin with dose determination in patients with metastatic prostate cancer; additional dose expansion cohorts, with specific histology, medical history, and/or expression of a specific biomarker may be launched via protocol modification; and/or modification of a particular biomarker may be initiated via protocol revision.

Source link: https://clinicaltrials.gov/ct2/show/NCT05413421


Evaluation of 18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer

By visual qualitative and quantitative SUV testing, we can determine whether DCFPyL PET can detect metastatic prostate cancer. Correspondence will be carried out to areas of suspected bony metastatic disease detected by ultra-sensitive but less specific [18F] Sodium fluoride -PET/CT imaging and all locations of suspected disease identified by [18F] Fluorodeoxyglucose for prostate cancer. Using a comparison to reference standard of care conventional imaging techniques such as CT and whole body bone scintigraphy, prior and follow-up scans and histopathology when available, with the aim of comparing the diagnostic sensitivity of DCFPyL-PET/CT to NaF-PET/CT for detection of prostate cancer bone metastasis. Patients must have either: Confirmation of prostate cancer with a specific metastatic disease on at least one clinically indicated imaging modality. Two Cohort Studies: PSA must be greater than or less than 0. 5 ng/mL value from the last PSA test conducted on at least two occasions within a year. During Cohort 2, patients will be enrolled in DCFPyL PET/CT, NaF-PET/CT, and FDG PET/CT within 21 days of each other. The DCFPyL PET/CT test will be compared to the NaF-PET/CT and FDG PET/CT and standard chest/abdomen/pelvis CT, as well as standard chest/abdomen/pelvis CT. DCFPyL's metastatic disease PET/CT findings will be assessed by visual qualitative analysis as positive, equivocal, or negative.

Source link: https://clinicaltrials.gov/ct2/show/NCT03173924


A Randomized Phase 2 Trial of Ascorbic Acid in Combination With Docetaxel in Men With Metastatic Prostate Cancer

Compared to placebo's docetaxel with ascorbic acid, a prostate specific antigen decline of >= 50% was found in the 8 cycles of docetaxel with ascorbic acid versus docetaxel with placebo. To determine the percentage of adverse events experienced by metastatic prostate cancer patients receiving either docetaxel with ascorbic acid or placebo with placebo, we compared the proportion of adverse events reported by placebo versus placebo. To determine the percentage of high-grade adverse events in patients with metastatic prostate cancer and compare treatment arms during eight cycles of therapy. To determine the number of high-grade adverse events in patients with metastatic prostate cancer and compare treatment arms through 8 cycles of therapy. Patients get docetaxel IV over 60 minutes on day one and placebo IV over 60 minutes thrice a week.

Source link: https://clinicaltrials.gov/ct2/show/NCT02516670


Evaluation of the Technical Feasibility of Testing Circulating Tumour DNA for Homologous Recombination Gene Variants in Metastatic Prostate Cancer.

However, in metastatic prostate cancer samples using formalin-fixed and paraffin-embedded samples, the failure rate is around 30%, in accordance with the PROFOUND study's findings, confirming a real pre-analytic problem when FFPE samples are used for NGS testing.

Source link: https://clinicaltrials.gov/ct2/show/NCT05415787


A Phase II, Single Arm Study of Chemoimmunotherapy for the Treatment of Men With Neuroendocrine or Aggressive Variant Metastatic Prostate Cancer (CHAMP)

The aim of this research is to determine the safety and efficacy of a combination of nivolumab, ipilimumab, cabazitaxel, and carboplatin in men with neuroendocrine prostate cancer or other unusual forms of prostate cancer. Subjects can continue receiving study chemicals until cancer progression, severe toxicity, voluntary withdrawal of consent, 3 years from the initial dose of study products or study termination, whichever comes first.

Source link: https://clinicaltrials.gov/ct2/show/NCT04709276


A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Metastatic Prostate Cancer

This review will examine the efficacy and safety of niraparib in conjunction with AAP for the treatment of patients with metastatic castration-resistant prostate cancer patients. Niraparib is an orally available, highly selective polymerase inhibitor with potent activity against PARP-1 and PARP-2 deoxyribonucleic acid-repair polymersases. In patients with metastatic prostate cancer, DNA-repair anomalies have been detected in approximately 15 percent to 20% of tumors. Participants will be tested for homologous recombination repair gene mutation status during the prescreening phase and then assigned to one of the two cohorts based on their biomarker status.

Source link: https://clinicaltrials.gov/ct2/show/NCT03748641


Asian Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral Enzalutamide in Chemotherapy Naïve Subjects With Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy

Despite androgen deprivation therapy, the study was conducted in a multinational Phase 3randomized, double-blind, placebo-controlled efficacy, and safety study of oral enzalutamide in asymptomatic or mildly symptomatic participants of progressive metastatic prostate cancer with disease progression despite androgen deprivation therapy. All the assessments planned on Day 3 were required to be hospitalized starting at Day 1 before the randomization date to at least the completion of all the assessments. The PK results were determined by blood sampling for the PK analysis.

Source link: https://clinicaltrials.gov/ct2/show/NCT02294461


18F-Fluciclovine PET CT as an Indicator of Therapeutic Response in Metastatic Prostate Carcinoma (M1PCa)

Evaluate physiological responses by fluciclevine F18 PET qualitatively and semi-quantitatively with standardized uptake values following androgen deprivation therapy plus abiraterone at 22-28 weeks, and compare the results with size changes as shown by conventional imaging and prostate-specific antigen responses. To determine 18F-flucicle PET imaging sensitivity and specificity for pelvic lymph node tumor involvement, compare pelvic 18F-fluciclevine PET imaging findings with pathologic findings at radical prostatectomy and pelvic lymph node dissection. OUTLINE: Patients receive fluciclomine F18 intravenously within four weeks before starting standard systemic therapy, and then have a PET scan that takes over 30 minutes.

Source link: https://clinicaltrials.gov/ct2/show/NCT04134208

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions