Clinical trials

The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the performance (both safety and efficacy) of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. The study provides approved targeted therapies that are contributed to the program by collaborating pharmaceutical companies, catalogues the choice of genomic profiling test by clinical oncologists and aims to learn about the utility of registry data to develop hypotheses for additional clinical trials.

NRG-GU010: PARALLEL PHASE III RANDOMIZED TRIALS OF GENOMICRISK STRATIFIED UNFAVORABLE INTERMEDIATE RISK PROSTATE CANCER: DE-INTENSIFICATION AND INTENSIFICATION CLINICAL TRIAL EVALUATION (GUIDANCE)

This is a Phase III, 2-cohort, 2-arm, parallel-group, randomised, double-blind, placebo-controlled, multicenter, global study, assessing the efficacy and safety of AZD5305 + physician's choice NHA compared with placebo + physician's choice NHA in participants with mCSPC with and without HRRm.

By establishing an acupuncture treatment regimen, this research will contribute to evidence-based guidelines for incorporating acupuncture as a non-pharmacologic intervention in supportive cancer care, with the potential to enhance quality of life outcomes among men with prostate cancer experiencing treatment-induced hot flashes.

The study is a pilot feasibility study of a randomized controlled trial. A total of 24 study participants will be randomized 1:1 into the intervention arm (immediate acupuncture, IA) or into the wait-list attention control arm (delayed acupuncture, DA), yielding 12 participants per arm, using simple randomization. Participants will be followed for 22 weeks.  

The primary aim of this study is to evaluate the feasibility and acceptability of the study procedures, recruitment strategies, and intervention delivery in a pilot randomized controlled trial investigating an acupuncture intervention for anti-androgen-induced hot flashes in men with prostate cancer. 

This Phase II study aims to evaluate efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg once a day (QD) doses + abiraterone compared with an androgen receptor pathway inhibitor (ARPI, abiraterone or enzalutamide) in participants with metastatic Hormone Sensitive Prostate Cancer (mHSPC) and to select the recommended dose of the combination for phase III. Towards that end, the totality of the efficacy, safety, tolerability and PK data from participants randomized in the study will be evaluated.