Clinical Trials

This phase II trial evaluates the impact of cancer therapy in the patients' home compared to in the clinic on safety, side effects, patient preference, and satisfaction in Black men with prostate cancer that has spread to nearby tissue or lymph nodes (locally advanced), that has increasing prostate-specific antigen after treatment (biochemically recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Typically drug-related cancer care is conducted at a medical center which causes patients to have to spend considerable time away from family, friends, and familiar surroundings. This separation may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. Therapy administered to a patient in the patients' residence in the comfort of familiar surrounding using Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) may help reduce psychological and financial distress, increase access to care and improve treatment compliance. Giving cancer therapy in the home compared in the clinic may be safe, tolerable and improve patient satisfaction with overall cancer care in Black men with locally advanced, biochemically recurrent or metastatic prostate cancer.

Prostate cancer is one of the most prevalent malignancies affecting men worldwide, ranging from localized tumors to aggressive, metastatic disease (Siegel et al. 2023). An enormous array of treatments is available for treating prostate cancers, but the field faces a critical challenge in the lack of reliable biomarkers across the spectrum of disease that can direct treatment. This challenge is especially pressing in the current landscape where novel therapeutic approaches and personalized treatments are transforming prostate cancer for our patients.

This clinical trial aims to address the critical gap in prostate cancer management by rigorously evaluating and validating prostate cancer-derived extracellular vesicles (PC-EVs) across time and treatments. Critically, we seek to define these questions for patients among under-represented populations in this multi-group, multi-department, multi-center, investigator-initiated trial.

The purpose of the study is to evaluate the impact on metastases-free survival with the addition of saruparib versus placebo to a standard RT + ADT regimen in men with high-risk and very high-risk (localised/locally advanced) prostate cancer with a BRCAm.

The aims of this study are to evaluate the prevalence of vitamin D insufficiency among B/AA prostate cancer patients and to determine the deficits in immunity associated with vitamin D insufficiency. Also, we will evaluate whether the peripheral blood immune cell function is different in B/AA prostate cancer patients with metastatic disease as compared with those with localized disease.

This is a prospective, single-arm investigative trial. Patients with high risk prostate cancer, defined by AUA guidelines, who elect robotic assisted radical prostatectomy with an extended pelvic lymph node dissection will have standard of care preoperative imaging with CT/MRI + NM Bone Scan compared with 18F-rhPSMA-7.3 PET/MRI. Preoperative clinicopathologic variables including PSA, prostate biopsy pathology results reported as Gleason grade and percent positivity, imaging tests and demographic information will be abstracted from the electronic health record at enrollment.

Intraoperatively the lymph node packets will be labeled according to laterality and location to include internal iliac, external iliac, common iliac, obturator packet, retropubic and sacral.  Following surgery there will be an expert pathologic review of the sampled lymph nodes by a dedicated GU pathologist and a corresponding comparison with preoperative imaging and patient risk AUA prostate cancer risk score. 

Following surgery, participants will visit the study doctor for their standard follow-up visits at 6 weeks, 3 months, 6 months, 9 months, and 12 months with corresponding PSA surveillance with adjuvant imaging or treatment as part of standard of care.

Proposed study is intended to be carried out at the Mayo Clinic in Jacksonville, Florida. Urologist Dr. Ram Anil Pathak will be the responsible Principal Investigator, primary surgeon, and counselor for the study patients. The PI and his assigned team will conduct the follow-up visits (6 weeks, 3-, 6-, 9- and 12-months) at the Urology Clinic of Mayo Clinic in Florida.

Patients will be assessed for safety by regular evaluation of adverse events (AE) as clinically indicated.

The purpose of this post-marketing study is to further characterize the long-term outcome of known or potential risks of lutetium (177Lu) vipivotide tetraxetan also known as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereinafter referred to as AAA617. The study also seeks to further characterize (as possible) any other serious adverse reaction(s) in the long-term in adults with prostate cancer who received at least one dose of AAA617 from interventional, Phase I-IV Novartis sponsored clinical trials.

The purpose of this study is to evaluate and assess a new perineal access tool to enable image guided prostate interventions by Clear Guide Medical in collaboration with the Mayo Clinic.

Multicenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901 as a monotherapy and in combination with pembrolizumab

The purpose of this study is to employ mixed methods approach to develop a prostate cancer survivorship care plan (CaP-SCP) tailored to US-born Black men (USbBM), Caribbean-born BM (CBBM) and African-born BM (ABBM) using clinicians’ key informant interviews and survey of CaP Black survivors and to develop a prototype of the digitalized CaP-SCP that integrates quantitative clinical, patient reported health-related quality of life (HRQOL) and population level data to assess the sensitivity and preliminary impact of the digitalized CaP-SCP  on Health Related Quality of Life (HRQOL) using community engagement research and behavioral precision medicine.

Augmented reality (AR) immersive technology in healthcare delivers unprecedented, intuitive, realistic visualization and interaction experience for patients in a synthetic and integrated fashion. AR can help patients to manage emotions, pain, combat anxiety or fears, and make better decisions. Combined with Artificial Intelligence (AI), with benefits of accurate machine-learning models, we propose to develop an integrated AI and AR technology Prostate Cancer (CaP) Survivorship Care Plan.

The digitalized CaP-SCP development will be led by the iCCaRE consortium’s Digital Health & Human Services core. They will develop a mobile app that integrates SDOH navigation, standard CaP psycho-oncology support and emotional support. The app’s content will be delivered through AI predictive analytic and recommender system and will be based on the previously conducted interviews and focus groups. 

The digitalized CaP-SRP when used by a patient, will present the following features: 
• A series of short survey questions, which is used by the AI model to predict or recommend a specific intervention(s), educative material(s), or AR interactions with personal CaP survival stories; 
• SDOH navigation that will appropriately connect them with relevant support services and resources in their communities; 
• An emotional support intervention that can establish an empathic rapport with a CaP survivor’s sharing of his story. This will be programmed based on one of the iCCaRe Consortium’s consumer advocates; 
• The psycho-oncology support will be programmed to provide psychoeducation about the PPCD experience, reify and concretize the PPCD experience, and foster hope; 
• Patients can choose to ignore the personalized recommendations and select from a drop-down menu list of contents. 

The app is expected to be downloaded to their mobile smartphone for introduction in the clinical setting and more in-depth use at home. The survivorship care plan can be taken with participants to follow-up appointments for reminders and updates to treatments. We anticipate participants acclimating to the app for approximately 30 minutes in the clinic

The purpose of this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.