Clinical Trials

Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.

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

This is a biomarker preselected, randomized, open-label, multicenter, phase II study in men with metastatic castration resistant prostate cancer (mCRPC). Patients with tumors that have ATM, BRCA1 and/or BRCA2 mutations/deletions/loss of heterozygosity will be randomized in a 1:1:1 fashion to each arm. Patients with mutations in noncanonical DNA repair genes including FANCA, PALB2, RAD51, ERCC3, MRE11, NBN, MLH3, CDK12, CHEK2, HDAC2, ATR, PMS2, GEN1, MSH2, MSH6, BRIP1, or FAM175A defects will be assigned to Arm IV with single agent olaparib.

The purpose of this study is to determine, with an acceptable upper bound confidence interval, disease free survival in patients who receive hypofractionated radiation for high risk prostate cancer. Exploratory objectives include chronic/late toxicity, among others. Late toxicity rates in the current study should besimilar to what is previously reported.

The objective of this study is to test the acceptability and feasibility of combining a commercially available smartwatch, which tracks critical biometric data for the prediction of disease progression in individuals with cancer, with human feedback based on smartwatch activity data tailored to meet each patient’s needs.

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.

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

We are studying whether men being treated for prostate cancer have the same amount of side effects from either one of two different external radiation treatments: IMRT or PBT. With IMRT, a number of x-ray beams are used to shape the radiation to the prostate. PBT is another type of external radiation treatment for prostate cancer that is used in a few centers in the United States. Protons are tiny particles with positive charge that can be controlled to travel a certain distance and stop. PBT is precise like IMRT, but it uses proton beams instead of x-ray beams. IMRT and PBT aim to deliver most of the radiation to the prostate cancer while sparing surrounding tissues. Both IMRT and PBT have been used in the treatment of prostate cancer and are thought to be equally effective at curing prostate cancer. However, both treatments have also been shown to cause the potential side effects of radiation, including bowel, urinary and erectile problems. It is possible that side effect rates with PBT will be lower, the same, or even higher than with IMRT, but this has not been studied well to date. Though both of these radiation therapies have been used in the past to treat prostate cancer, there has never been a study that compares the effects of these two therapies to see which one has less side effects. In this research study, we are comparing IMRT to PBT to determine which therapy best minimizes the side effects of treatment.

This phase II trial tests how well abiraterone acetate/niraparib (CJNJ-67652000 [niraparib/abiraterone acetate fixed-dose combination]) and prednisone works in treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and who have a mutation in the SPOP gene. CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination) is a drug which stops certain cancer cells from being able to repair themselves from damage, leading to the death of the cancer cell. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving CJNJ-67652000 and prednisone may kill more tumor cells in patients with metastatic prostate cancer than giving these drugs alone.

This phase II trial studies how well giving bicalutamide with or without Akt inhibitor MK2206 works in treating patients with previously treated prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether bicalutamide is more effective with or without Akt inhibitor MK2206 in treating prostate cancer.