Clinical Research Directory

Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder

This study is assessing the efficacy and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis. Who is it for? This study is for people who are aged between 18 and 80 years old and suffer from anxiety after adjusting to an acutely stressful event of their cancer diagnosis. This is called adjustment disorder. Study details Participants in this study will be randomly allocated by chance (similar to flipping a coin) to one of three groups: a 25mg NPX-5 dose group, a 10 mg NPX-5 dose group or a 1mg NPX-5 dose group. Participants will be allocated a dose that will be administered during their psilocybin-assisted psychotherapy (PAP) dosing session. The PAP dosing session will run approximately 8 hours, with NPX-5 administered at Day 14 (dosing day). At Week 10, non-responders that continue to meet the study eligibility criteria may commence an additional PAP cycle (at 25 mg NPX-5). A maximum of 2 PAP cycles may be administered. Long term follow up will comprise of a study visit at 3 months post Week 10 (of the final cycle) to assess safety and tolerability of NPX-5. It is hoped that this research will develop important scientific knowledge that could contribute to the development of a potential new treatment for anxiety and depression after adjusting to an acutely stressful event such as a cancer diagnosis.

Onco-primary Care Networking to Support TEAM-based Care

The proposed ONE TEAM Study is an 18-month, cluster randomized controlled trial. This study will use a sequential multiple assignment randomized trial (SMART) design with a second randomization for the intervention group using a dynamic treatment regimen approach. The investigators propose to randomize 800 adults with newly-diagnosed selected cancers treated with curative intent (breast, prostate, colorectal, endometrial, non-small cell lung, and endometrial) and with \>1 selected cardiovascular disease (CVD) comorbidity (hypertension, type 2 diabetes mellitus, hypercholesterolemia). Participants will be enrolled through Duke Cancer Institute and two community-based oncology practices, both settings serving socio-demographically diverse populations. The unit of randomization will be the PCP clinic; there will be \~80 PCP clinics across North Carolina involved in the study. The overarching goals of this study are to improve chronic disease management and communication among cancer survivors by engaging PCPs as active members of the cancer care team and reframing the message to cancer survivors and providers. A diversity supplement with retrospective and qualitative components has been added to abstract older adults with solid tumors who underwent cancer surgery at DUHS. Aims include (1) to estimate the prevalence of cardiovascular complications ≤90 postoperative days among older adults with solid tumors undergoing surgery, and its association with care coordination between surgical providers and PCPs ; (2) to develop a risk index for cardiovascular complications ≤90 days of surgery among older adult patients with a solid tumor; and (3) to Assess experience and perceptions of PCPs on care coordination with surgical providers of older adults with a solid tumor following cancer surgery.

The Impact of Physical Activity Versus Dietary Energy Restriction on Tumour and Muscle Protein Synthesis in Prostate Cancer Patients

Background: Prostate cancer is the second most common cancer and the fifth leading cause of death in men worldwide. Tumour growth is attributed to disproportionately greater protein synthesis rates relative to protein breakdown rates. Tumour protein synthesis is modulated by several factors, including energy availability, blood flow, and hormone concentrations (e.g., IGF-1). Lifestyle modifications are rapidly becoming recognized as important adjunct therapeutic approaches to slow cancer development and enhance treatment efficacy. Dietary energy restriction is a 30-50% reduction in food intake, which induces an energy deficit and has been shown to attenuate tumour growth in rodent models. Muscle mass often declines during cancer treatment and negatively impacts treatment success rates and recovery. One drawback to dietary energy restriction is that it may accelerate declines in skeletal muscle mass and strength in cancer patients. Exercise also induces an energy deficit by increasing energy expenditure. In addition, exercise alters blood flow and releases circulating molecules, which appear to lower tumour protein synthesis rates. Exercise increases muscle protein synthesis rates, which would provide further benefits to cancer patients by helping to maintain skeletal muscle mass. Despite their promising therapeutic properties, the clinical efficacy of dietary energy restriction and exercise has not been directly determined in vivo in cancer patients. Hypothesis and Objectives: The objective of this study is to compare the impact of dietary energy restriction versus (isocaloric) daily exercise on muscle, prostate, and prostate tumour protein synthesis rates over a 7-day period in vivo in prostate cancer patients. It is hypothesized that 1) dietary energy restriction will lower both prostate tumour and muscle tissue protein synthesis rates and that 2) daily exercise will lower prostate tumour protein synthesis rates but increase muscle protein synthesis rates in prostate cancer patients. Setting and Methods: Forty-five prostate cancer patients scheduled to undergo radical prostatectomy will be randomly assigned to one of three groups. The first group will undergo 7 days of dietary energy restriction (40% less food intake). The second group will perform 7 days of daily exercise and mild dietary energy restriction resulting in a total energy deficit of 40%. The third group will follow their regular diet and physical activity (control group). The research team will provide all aspects of the intervention (standardized meals, personalized exercise supervision). Patients will ingest deuterium-labelled water (2H2O) throughout the intervention period. After 7 days, patients will undergo a radical prostatectomy, during which tumour tissue, skeletal muscle tissue, and blood will be collected. Deuterium (2H-alanine) incorporation into the tissue samples will be measured to assess prostate tumour and skeletal muscle tissue protein synthesis rates.

Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer

This is a pilot study of the tolerability and safety of neoadjuvant dapagliflozin for patients with unfavorable intermediate, high-risk, or very high-risk prostatic adenocarcinoma prior to radical prostatectomy. The primary hypothesis is that four weeks of daily dapagliflozin prior to surgery is well-tolerated and safe to use in this patient population. The investigators also hypothesize that dapagliflozin will be efficacious in resulting in tumor shrinkage on pre-operative imaging and will result in tumor necrosis at prostatectomy.

Improving Sexual Quality of Life - Randomized Trial of Two vs Five MRI Guided SABR Treatments for Prostate Cancer

Prostate Stereotactic ablative body radiotherapy (SABR) is an established technique that delivers radiation in a non-invasive approach for men with prostate cancer. The treatment regimen is given in total of 5 fractions with one treatment per day at every other day or weekly sessions. Ultra-hypofractionated radiotherapy (UHRT) is an emerging monotherapy for localized prostate cancer however, several trials have observed demonstrating superior biochemical control of a two-fraction (HDR) over single-fraction approach. The study aims to compare an experimental shorter course of prostate ultra-hypofractionated radiotherapy (UHRT) that will deliver what is expected to be an equivalent amount of radiation as given in the standard 5 treatment regimen. UHRT is given in 2 treatments with one treatment a week for 2 consecutive weeks.

Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA

Darolutamide is a drug that has a proven survival benefit in non-metastatic (M0) castrate resistant prostate cancer when using conventional imaging. However, it is estimated that \>90% of patients have disease apparent when using PSMA PET. This study investigates the use of local consolidation radiotherapy in this cohort of men.

Real-time Motion Management During Prostate and Lung Radiotherapy

The goal of this interventional non-inferiority trial is to assess the accuracy of different real-time motion management radiotherapy techniques. The main question the study aims to answer are: * What are the target margins for radiotherapy with motion management that are not inferior to target margin without motion management * What are the dosimetric and geometrical accuracy to patient for the motion management techniques. Participants will answer QoL questionary, and the accuracy of treatment will be assessed from treatment data.

Investigation of Three Biomarkers for the Detection of Prostate Cancer

GlycoScore Dx Limited, a diagnostics company based in the United Kingdom have identified three glycoproteins, that showed promise as biomarkers of prostate cancer in initial validation studies. The purpose of this study is to further evaluate the sensitivity and specificity of the GlycoScore biomarkers for the detection of clinically significant prostate cancer. Sensitivity and specificity will be determined for each marker, combinations of the three markers and combinations of the GlycoScore biomarkers with PSA (prostate specific antigen). The results from this study will be used to identify the most suitable biomarker/biomarkers for use in developing a GlycoScore test. This is a prospective, non-interventional study using venous blood samples taken from patients with suspected prostate cancer or on active surveillance, attending the hospital Urology department for a transperineal biopsy.

A Intervention for Reducing Sedentary Behaviour Among Prostate Cancer Survivors

This randomized controlled trial (RCT) will aim to examine the effect of a 12-week behavioural intervention on changing the sedentary behaviours (SB) of prostate cancer survivors (PCS) compared to a control group (FitBit-only group). PCS in the intervention group will receive a FitBit and 6 behavioural support sessions with a movement specialist guided by behavioural theory (i.e., the Multi-Process Action Control \[M-PAC\]). The FitBit-only group will only receive a FitBit and access to public health resources on physical activity (PA). The primary purpose of this study is to determine the efficacy of the intervention on changing SB of PCS immediately following the 12-week intervention and 6-months later. It is hypothesized that that the intervention will decrease their SB compared to the FitBit-only control condition at both timepoints. This trial will also examine the effect of the intervention on changing PA, motivational outcomes from the M-PAC framework, sleep quality, social support, physical function, quality of life, fatigue, disability and mental health compared to the active control condition.

ARCHERY - Artificial Intelligence Based Radiotherapy Treatment Planning for Cervical, Head and Neck and Prostate Cancer

The aim of this study is to look at whether an Artificial Intelligence (AI) based computer program can automate two components of the radiotherapy treatment pathway to a sufficient quality standard to enable its routine clinical use. The two components include the delineation (outlining) of anatomical areas that are at risk of tumour spread and at risk of radiation damage, and the definition of the position, size and shape of the radiation beams. The AI-based computer programs have been developed to perform tasks that would normally require direct human involvement by oncologists and medical physicists. Proposed advantages include improved treatment accuracy, as well as a reduction in the time (from weeks to minutes) and human resources needed to deliver radiotherapy, which this study will test.

Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention

This is a prospective randomized multicenter study aimed at comparing 3D AI-AR-RARP vs. no 3D, verifying the impact of this new technology on oncological and functional outcomes after the procedure.