Clinical Research Directory

Integrated Actionable Aging Assessment for Cancer Patients Pilot

Aging is the greatest risk factor for cancer incidence and mortality. Geriatric screening is recommended to help with treatment discussions, inform intensity of treatment, and identify supportive care needs. Despite a strong evidence base, geriatric assessments are not implemented routinely in oncologic clinics. Similarly, important information on social determinants of health, mental health, and health behaviors are inconsistently assessed, and almost never in an integrated fashion. In an effort to support clinicians delivering the recommended goal-concordant care, the investigators will integrate assessment of geriatric issues, health behaviors, mental health, and social determinants of health into an efficient, actionable contextual assessment system for older cancer patients called Integrated Aging Assessment for Action for Cancer Patients (IA3-CP). The investigators will use D\&I strategies including co-creation engagement approaches and form-function methods to develop workflow processes that feasibly integrate the IA3-CP into usual initial assessment with the oncology team. Our objective is to develop and conduct a randomized pilot of the IA3-CP system and hypothesize that our results will show it can be implemented consistently, acted on, improve quality of care, and enhance patient-provider interactions.

Whole Versus Partial Gland Boost During Prostate SBRT

The purpose of this randomized phase II trial is to compare dose escalation of the prostate versus the dominant intra-prostatic lesion in a reduced fraction radiation therapy regimen.

STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma

Background: Immunotherapy is a type of treatment that works by making the body s own immune system stronger. These treatments are used for cancers such as non small cell lung cancer (NSCLC); thymic carcinoma (TC); or metastatic castrate-resistant prostate cancer (mCRPC). But these cancers may still come back after treatment. Objective: To test a new immunotherapy drug (STAR0602), alone or combined with an approved drug (nivolumab), in people with NSCLC, mCRPC, or TC. Eligibility: People aged 18 years or older with NSCLC, mCRPC, or TC that did not respond to treatment or returned after treatment. Design: Participants will be screened. They will have blood and urine tests. They will have imaging scans and a test of their heart function. STAR0602 and nivolumab are given through a needle inserted into a vein (infusion). Participants will be treated in 28-day cycles. They will receive infusions of 1 or both drugs on the first and 15th day of each cycle. They will remain in the hospital for up to 5 days after their first 2 infusions of STAR0602. Imaging scans, blood tests, and other tests may be repeated during study visits. Participants may opt to have tissue samples (biopsies) taken from their tumors. Some blood and tissue samples may be used for genetic tests. Participants may continue getting STAR0602 for up to 2 years and nivolumab for up to 6 months. Participants will have an end-of-study visit within 1 month, and follow-up phone calls 1 month and 3 months, after they stop the study drug. Long-term follow-up calls and visits will continue every 3 to 6 months for up to 5 years.

Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)

This study will evaluate the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures.

Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer

The goal of this multicenter randomized controlled trial (RCT) is to evaluate the efficacy of different prostate biopsy schemes, including perilesional biopsy (PB) and combination of systematic biopsy and targeted biopsy (TB+SB). The main questions it aims to answer are: Does PB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of PB in improving the safety of prostate biopsy? Researchers will compare the cancer detection rates of PB and TB+SB to explore the efficacy of different prostate biopsy schemes. Participants will: Receive TB+PB or TB+SB.

Artificial Intelligence (AI)-Assisted Risk-based Prostate Cancer Detection

This is a prospective clinical study recruiting 510 men at risk of PCa to undergo urine, blood, AI-assisted ultrasound and AI-assisted MRI investigations to stratify risk of clinically significant PCa (csPCa). (sample size calculation in section 5)

Prostasomes as Diagnostic Tool for Prostate Cancer Detection

Prostate cancer is the most frequently diagnosed cancer among men over 50 years old in Western societies, with an incidence that is steadily increasing in most countries. The current, most commonly used biomarker for prostate cancer is prostate specific antigen (PSA), which has well known limitations in accuracy and requires additional testing. However, prostate cancer cells secrete exosomes, also known as prostasomes, which are only detectable in the blood of prostate cancer patients. The presence of prostasomes in the blood is in itself a prostate cancer diagnosis. However, the assay that has been designed for the purification of prostasomes requires additional testing for evaluating its robustness and usefulness in the clinical setting. Additionally, the evaluation of the cargo of the purified prostasomes may provide more information on the nature of the prostate cancer, which may help develop a molecular assay for a prostate cancer liquid biopsy rather than a tissue biopsy. Therefore, the purpose of this study is two-fold: a validation phase where the purification of prostasomes will be tested on plasma collected from prostate cancer patients and a molecular testing phase where the contents of the purified prostasomes will be evaluated on their ability to determine the grade of the prostate tumors. We will collaborate with Dr. Masood Kamali-Moghaddam at the Uppsala University (Department of Immunology, Genetics and Pathology) for molecular assay processing.

MRI Prostate for Chinese Men Being Screened for Prostate Cancer

Under the prostate cancer screening protocol of the project 'Prevention of Obesity-related Cancers', men with elevated PSA with higher prostate cancer risk (PSA 4-10 ng/mL with high Prostate Health Index (PHI) ≥35, or PSA\>10 ng/mL) will be offered a prostate biopsy. In the current study, we would like to offer all screened men with elevated PSA in the range of 4-50 ng/mL a biparametric non-contrast MRI prostate (screening protocol) for any suspicious lesion in the prostate. If there is MRI lesion seen, additional targeted biopsies can be performed on top of the standard systematic prostate biopsies. It has been shown in a clinical Caucasian cohort that doing MRI-targeted biopsies resulted in improved detection of clinically significant prostate cancer compared with standard systematic biopsies. In this study investigators would like to investigate the benefits of adding MRI prostate and MRI-targeted biopsy in the diagnostic pathway for prostate cancer in a screened cohort of Chinese men at risk of prostate cancer.

18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer

Background: Prostate cancer is the second leading cause of cancer deaths in American men. When prostate cancer is confined to the prostate there is a high chance of cure. However, it is outside the prostate or comes back after treatment, additional therapy may be needed. Current methods of imaging prostate cancer are limited. Researchers want to see if a radiotracer called 18F-DCFPyL can identify prostate cancer in patients who have a high risk of cancer spreading outside the prostate or who have signs of recurrent cancer after treatment. Objectives: To see if the radiotracer 18F-DCFyL can help identify prostate cancer in the body before or after therapy. Eligibility: Men ages 18 and older who have prostate cancer that has been newly diagnosed, or has relapsed after radiation or surgery Design: Participants will be divided into 2 groups. * Group 1 will be men with cancer that has been newly diagnosed as high risk by their doctor who are scheduled to have prostate removal surgery or undergo biopsy before radiation therapy. * Group 2 will be men who have presumed prostate cancer relapse after prostate removal surgery or radiation therapy. Both groups will have scans taken. Participants will lie still on a table in a machine that takes pictures of their body. 18F-DCFyL will be injected by intravenous (IV) line. Participants will be contacted for follow-up after scans. Participants in Group 1 may have surgery to remove their prostate gland or a biopsy to remove some prostate tissue. This procedure will be standard of care and is not a part of this study. They will also have an extra MRI scan of their prostate. For this, a tube, called an endorectal coil, will be placed in their rectum. Other tubes may be wrapped around the inside of their pelvis. A contrast agent will be given by IV. Participants in Group 2 may also undergo an MRI of the pelvis and may have a biopsy of abnormalities found on the 18F-DCFyL scan. Participants will have data about their prostate cancer collected for up to 1 year.

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

Background: Prostate cancer is the second leading cause of cancer deaths in American men. Few options exist to create images of this type of cancer. Researchers think an experimental radiotracer called 18F-DCFPyL could find sites of cancer in the body. Objective: To see if 18F-DCFPyL can identify sites of prostate cancer in people with the disease. Eligibility: People ages 18 and older who have metastatic prostate cancer Design: Participants will be screened with: * Blood tests * Physical exam * Medical history Participants will be assigned to 1 of 2 groups based on their PSA. Participants will have 18F-DCFPyL injected into a vein. About 2 hours later they will have a whole-body Positron Emission Tomography/Computed Tomography (PET/CT). For the scan, they will lie on their back on the scanner table while it takes pictures of the body. This lasts about 50 minutes. On another day, participants will have 18F -NaF injected into a vein. About 1 hour later, they will have a whole-body PET/CT. Participants will be contacted 1 3 days later for follow-up. They may undergo PET/Magnetic Resonance Imaging (MRI) either after having a 18F-DCFPyL PET/CT, or in place of PET/CT imaging. A tube may be placed in the rectum. More coils may be wrapped around the outside of the pelvis. If the 18F-DCFPyL PET/CT is positive participants will be encouraged to undergo a biopsy of one of the tumors. The biopsy will be taken through a needle put through the skin into the tumor. Participants will be followed for 1 year. During this time researchers will collect information about their prostate cancer, such as PSA levels and biopsy results. About 4-6 months after scanning is completed, participants may have a tumor biopsy. The biopsy will be taken through a needle put through the skin into the tumor. ...

Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance

Background: Prostate cancer is the second most common cause of cancer-related death among men in the United States. Early-stage, low-grade prostate cancer is managed with active monitoring. However, 35% of men with this cancer will need treatment within 5 years because of tumor growth. Researchers want to know if a new vaccine that targets 3 anti-cancer proteins (TriAdeno) plus a drug (N-803) approved for bladder cancer can help stop prostate tumors from growing. Objective: To test TriAdeno and N-803 in people with early-stage prostate cancer. Eligibility: People aged 18 years and older with early-stage low- or medium-risk prostate cancer. Design: Participants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have an imaging scan. They may have a rectal exam. TriAdeno is injected under the skin of the upper thigh; N-803 is injected under the skin of the abdomen. Participants will be treated in up to four 21-day cycles. They will get both injections on the first day of each cycle. Participants may opt to complete a memory aid: They may record all of their symptoms for 7 days after each injection. They may also complete a questionnaire about their prostate symptoms. Blood tests, imaging scans, and other tests will be repeated during the study. A tissue sample (biopsy) of the tumor will be collected during or after cycle 2; a second biopsy may be taken about 1 year later. Participants will have follow-up phone calls for 5 years....

To Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence

It is a prospective paired-cohort study for diagnostic test evaluation. The study aim to determine the accuracy of AI review and investigate whether AI review could detect MRI visible significant cancer as effective as radiologist review. MRI image of about 368 men recommended for biopsy will be reviewed by an AI model and an experienced radiologist, respectively. AI review (index) and radiologist review (standard) will be blinded to each other, while biopsy urologists will be well-informed of the findings of both AI review and radiologist review and make personalized biopsy plan by combining both findings. The pathological results of MRI-ultrasound fusion biopsy (reference) will serve as the gold standard to assess the diagnostic accuracy.

Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer

Background: Head and neck cancers (HNCs) account for about 5% of all cancers worldwide. They grow in the mouth, throat, nasal cavity, or salivary glands. Prostate cancer is the most common cancer in men in the United States. Survival rates for these cancers are lower than 50% if they spread to other parts of the body or return after treatment. Better treatments are needed. Objective: To test a new drug (SX-682), combined with an approved drug (docetaxel, or DTX), in people with HNCs or prostate cancer. Eligibility People aged 18 years and older with an HNC or prostate cancer that has returned after treatment or has spread. Design: Participants will be screened. They will have blood tests, imaging scans, and a test of their heart function. A tissue sample (biopsy) of the tumor may be taken. Participants will take the study drugs in 3-week cycles. SX-682 is a tablet taken by mouth twice a day from Days 1 to 11 of each cycle. Participants will get a supply of the drug to take home. DTX is given on Day 8 of each cycle through a tube attached to a needle inserted into a vein in the arm. Participants will come to the clinic on Days 1 and 8 of every cycle. They will take both drugs for up to 6 cycles. Participants will have follow-up visits 1 week and 1 month after they finish taking the drugs. Follow-ups will continue every 3 months for 2 years. Then they will have phone or email check-ins twice a year until 5 years have passed.

Researching the Effect of Exercise on Cancer

Researchers think that exercise may be able to prevent cancer from coming back by lowering ctDNA levels. The purpose of this study is to explore how aerobic exercise (exercise that stimulates and strengthens the heart and lungs and improves the body's use of oxygen) can reduce the level of ctDNA found in the blood. During the study, the highest level of exercise that is practical, is safe, and has positive effects on the body that may prevent the return of cancer (including a decrease in ctDNA levels) will be found. Each level of exercise tested will be a certain number of minutes each week. Once the best level of exercise is found, it will be tested further in a new group of participants. All participants in this study will have been previously treated for breast, prostate, or colorectal cancer.

A Nutraceutical Intervention in Patients With Previously Untreated Human Prostate Cancer

The purpose of this study is to evaluate weather a novel nutraceutical intervention (F-989) can improve prostate-specific antigerm (PSA) levels and Gleason scores in prostate cancer patients who are on active surveillance.

MATCH-UP: MAking Telehealth-Delivery of Cancer Care at Home Effective and Safe-Upscaled: A Pragmatic Cluster Randomized Trial

Many people with cancer spend a lot of time and money traveling to and from the doctor's office for cancer care. MSK's goal is to make getting cancer care easier by cutting down the need to make in-person visits to MSK. MSK is trying to do this through a new option called enhanced telehealth.

Natural History Study of Early Life Exposures in Agriculture (ELEA)

Study Description: ELEA is an observational cohort study that will collect exposure information and biospecimens from the adult children of the Agricultural Health Study (AHS) cohort (https://aghealth.nih.gov/about; Protocol OH93NCN013). The primary hypothesis is that early life exposures, particularly those found in the agricultural environment, are associated with cancer and other adverse health outcomes in childhood and early adulthood. Eligible individuals will be invited to complete an online questionnaire. After enrollment, study participants may be asked to donate biological and environmental samples. Participants will be followed for cancer and other disease endpoints. Data will be collected from North Carolina and Iowa health registries, disease specific databases, the National Death Index (NDI), North Carolina and Iowa state health registries, publicly available environmental datasets, discarded sample repository, and collection of available samples. Investigators will access data and biospecimens from the AHS protocol OH93NCN01 and link it to the ELEA population. In an earlier ELEA protocol (16CN095) the NCI SS IRB approved the protocol to perform linkages. That protocol was closed after the transition to the NIH IRB (per a NHSR determination), but the linkage work continued under the ELEA protocols that remained open with Westat and Iowa. Objectives: Primary: To investigate the effect of specific pesticides and other agricultural exposures and risk of cancer in children and adults. Secondary: To investigate the effect of non-agricultural exposures and the risk of cancer and other diseases in children and adults. Exploratory: Exploratory objectives include, but are not limited to, the examination of genetic and various molecular biomarkers in relation to childhood agricultural exposures. Endpoints: Primary: Incidence of Cancer Secondary: Incidence of diseases other than cancer, survival, and various molecular biomarkers. ...

NeoAdjuvant Theranostic Lutetium Study: The Nautilus Trial

To learn if the proposed dose of 177Lu rhPSMA-10.1 is safe. Phase 2 will open if the Phase 1 dose is found to be safe. To learn about the safety and effects of 177Lu rhPSMA-10.1 alone and with androgen deprivation therapy (ADT) on patients with high-risk, localized prostate cancer before they have surgery to remove the disease.

Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance

The purpose of this study is evaluate the safety of testosterone replacement therapy in men with newly diagnosed low-risk prostate cancer and hypogonadism on active surveillance.

A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors

This is a Phase 1b, 2-part, multi-center, open-label study to evaluate the safety, tolerability, dosimetry, and pharmacokinetics (PK) of \[64Cu\]Cu-AKY-2519 and/or \[225Ac\]Ac-AKY-2519, as well as the preliminary anti-tumor activity of \[225Ac\]Ac-AKY-2519 in participants with B7-H3 imaging positive solid tumors.

Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in Prostate Cancer

To learn about the effectiveness of adding talazoparib to the standard of care treatment combination of androgen ablation therapy (hormone therapy, also known as ADT) and enzalutamide in patients with prostate cancer that has spread into the lymph nodes.

Autonomic and Renal Contributions to Hypertension With ADT

This study plans to learn more about contributors to high blood pressure in men who undergo androgen deprivation therapy (ADT) to treat prostate cancer. Prostate cancer is the most common non-skin cancer in men, affecting approximately 1 in 8 American men and its primary treatment is through the use of ADT. However, ADT increases the likelihood of developing heart disease including high blood pressure. This study will determine if dysfunction of the nervous system and/or kidneys occurs in men undergoing ADT, as these systems play a significant role in control of blood pressure. The results from this study will help us understand the ways in which ADT contributes to heart disease and help us develop therapies to prevent heart disease in prostate cancer survivors.

Evaluating Tolerability of ePUHRT With Brachytherapy Boost

The purpose of this study is to evaluate the tolerability and toxicity of combining two radiation therapy methods for prostate cancer: Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT), which is an external beam radiotherapy with High Dose Rate Brachytherapy Boost (form of internal radiation where a cancer doctor implants a small plastic tube or balloon (catheter) in the tumor).

Expanded Access to Immunomodulatory AVM0703 for Solid Tumor and Blood Cancer Patients

AVM Biotechnology, Inc., provides immunomodulatory AVM0703 to solid tumor and blood cancer patients upon request by a US licensed MD or DO. As of July 2024, 37 patients have been treated through this FDA-EAP including patients diagnosed with relapsed or recurring glioblastoma, inoperable/chemotherapy ineligible CNS Squamous Cell Carcinoma, metastatic Breast Cancer, ovarian cancer, gastric cancer, Hodgkin's Lymphoma, Mixed Phenotype Acute Myelogenous Leukemia, colon cancer, B-ALL, Malignant Myxoid Spindle Cell Neoplasm, non-small cell lung cancer, DLBCL with CNS involvement, metastatic prostate cancer, Anaplastic T-cell Non-Hodgkin's Lymphoma and metastatic pancreatic cancer. Drug-related side-effects are predominantly grade 1 and include itching during the infusion and about 1 week of low grade insomnia.