Tag: Clinical Trials

Weill Cornell at PSMA & Beyond 2025: A Front-Row Seat to the Future of Theranostics

The PSMA & Beyond 2025 Conference returned for its highly anticipated second edition, this time hosted in vibrant Los Angeles, California. Organized by University of California, San Francisco (UCSF), University of California, Los Angeles (UCLA), and the Prostate Cancer Foundation (PCF), this two-day event convened many of the world’s leading voices in prostate cancer theranostics, a cancer treatment approach that combines diagnostic imaging and targeted therapy. This highly specialized, niche conference drew over 600 attendees both virtually and in-person from around the globe, bringing together leaders at the forefront of cancer imaging and targeted therapy.

This multidisciplinary event featured stakeholders across molecular imaging, medical oncology, urology, radiation oncology, and other key disciplines—offering key insights to the rapidly advancing field of prostate-specific membrane antigen (PSMA) theranostics and precision medicine.

A Dynamic Program at the Cutting Edge

This year’s program explored both the current landscape and emerging directions in PSMA PET imaging and radioligand therapy. Sessions spanned a diverse range of topics—from the evolving role of bone scans, MRI, and PSMA PET in clinical decision-making, to therapeutic advances involving beta and alpha-emitting agents, radiopharmaceutical development, resistance mechanisms, and the emergence of novel tracers and ligands.

The conference also featured groundbreaking research in radiation measurement and the integration of artificial intelligence (AI), both aimed at enhancing the efficiency, accuracy, and personalization of theranostic approaches. Highlights included interactive tumor boards, engaging panel discussions, and visionary presentations that pushed the boundaries of what’s possible—not just in prostate cancer, but in theranostics more broadly.

In an exciting and timely development, Day 1 of the conference coincided with the U.S. Food and Drug Administration (FDA)’s announcement of an expanded indication for Pluvicto—the first FDA approved PSMA targeted theranostic which is now also approved earlier in the disease trajectory, prior to taxane-based chemotherapy. This marks a major milestone in expanding access and optimizing treatment sequencing for patients with metastatic prostate cancer.

Spotlight on WCM Rising Research Talent

The conference also hosted a vibrant poster session, featuring cutting-edge abstracts. Among the standout contributions was research by Dr. Valentina Marulanda-Corzo, Molecular Imaging and Therapeutics Research Fellow at WCM. Under the mentorship of Dr. Joseph R. Osborne, Chief of Molecular Imaging and Therapeutics, Dr. Marulanda-Corzo presented her abstract titled “PSMA-Targeted Actinium-225 Therapy in Metastatic Castration-Resistant Prostate Cancer: Integrating Imaging Biomarkers with Clinical Outcomes in Monotherapy and Combination Therapy.”

Her work showcased how quantitative imaging biomarkers can provide insights that go beyond PSMA expression, offering critical prognostic and therapeutic value. By integrating imaging data with clinical outcomes, her research underscores the pivotal role of imaging in guiding personalized treatment strategies and advancing the field of precision oncology.

Selected as one of only ten “Power Pitch” presentations, Dr. Marulanda-Corzo’s abstract was ultimately recognized as one of the top three poster presentations of the entire conference—an incredible achievement and a powerful testament to the innovation and leadership emerging from Weill Cornell Medicine.

Weill Cornell Medicine at the Forefront

Weill Cornell Medicine (WCM) was proudly represented at this premier conference. Dr. Scott Tagawa, a medical oncologist at WCM and an internationally recognized leader in PSMA-targeted therapy, delivered a compelling presentation titled “The Role of PSMA Targeted Antibodies.” Drawing from ongoing clinical trials at WCM, Dr. Tagawa explored the development and therapeutic promise of J591, a monoclonal antibody that targets the extracellular domain of PSMA—enabling highly selective delivery of both beta and alpha-emitting radionuclides.

His presentation emphasized the clinical relevance of this platform, particularly in patients with low or varying PSMA expression, where small-molecule ligands may fall short. He shared promising clinical outcomes using Actinium-225-labeled J591, and highlighted how alpha emitters are reshaping the therapeutic landscape.

Notably, Dr. Tagawa explored the synergistic potential of combination strategies—such as pairing alpha and beta emitters or integrating alpha therapy with immunotherapy—to deepen response and overcome treatment resistance. His talk reinforced that the future of PSMA-targeted therapy lies not only in precision, but in innovation, through multidimensional approaches that could redefine cancer care.

This year’s PSMA & Beyond Conference served as a powerful reminder that the fusion of imaging and therapy is not just a scientific frontier—it is a transformative movement redefining how we approach cancer care. At Weill Cornell Medicine, we are proud to be at the center of this evolution, advancing theranostics through research, collaboration, and a deep commitment to patient-centered innovation.

Radiopharmaceutical Treatments for Metastatic Prostate Cancer

Radiopharmaceuticals (also sometimes called targeted radionuclide therapy or similar) are a type of medication that uses particles of radiation injected into the bloodstream to affect cancer. Radiopharmaceuticals are typically comprised of a radioactive particle, known as a radionuclide, sometimes combined with a targeting molecule that directs the radiation or points it towards a particular place. When injected into the body, this type of therapy is able to deliver radiation directly to the pointed target, limiting the exposure to the surrounding healthy tissue.

In prostate cancer, radiopharmaceuticals can be used in patients with metastatic prostate cancer that is not responding to hormonal therapy. While these treatments aren’t a cure, they are able to help these patients live longer with a better quality of life.

There are currently two radiopharmaceuticals approved by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic prostate cancer. Both of these treatments are given via an intravenous (IV) injection or infusion, similar to other forms of cancer treatment.

Radium Ra 223 dichloride (Xofigo) was approved in 2013 and is used to target bone. In the setting of prostate cancer that has metastasized to the bones, patients live longer with this treatment.

Lutetium Lu 177 vipivotide tetraxetan (aka 177Lu-PSMA-617, Pluvicto) was approved in 2022 and delivers prostate-specific membrane antigen (PSMA) targeted radiation to prostate cancer cells that express PSMA (which encompasses the majority of prostate cancer). It can be used to treat PSMA-expressing cancer that has metastasized anywhere in the body, including the bones, internal organs, and lymph nodes.

New radiopharmaceutical treatment options are also being evaluated in clinical trials. A phase 1 clinical trial led by Dr. Scott Tagawa at Weill Cornell Medicine/NewYork-Presbyterian Hospital (WCM/NYP) evaluated the radiopharmaceutical 225AC-J591 in patients with advanced prostate cancer. Multiple additional studies of 225AC-J591 alone or in combination with other therapies are now underway at WCM to further assess the safety and efficacy of 225AC-J591.

In addition, multiple additional radiopharmaceuticals are in development, including drugs such as 67Cu-SAR-bisPSMA, 177Lu-rhPSMA-10.1, and TLX591. A full list of our open clinical trials in this area can be found here.

Patients with prostate cancer interested in radiopharmaceutical treatment should speak to their doctor to determine if this therapy may be a good option based on their individual situation. Patients will need to undergo two scans to determine if they are eligible to receive a radiopharmaceutical. One may be a bone scan to determine if the cancer has metastasized to the bones and the second may be a PSMA positron emission tomography (PET) scan to determine if the cancer cells have a high level of PSMA protein.  

To learn more about radiopharmaceuticals for metastatic prostate cancer, read this in-depth patient-friendly overview from Everyday Health featuring insights from Dr. Scott Tagawa, facts about radiopharmaceuticals, questions to ask your doctor about this treatment option, and more.

You can also learn more about the prostate clinical trials open at Weill Cornell Medicine/NewYork-Presbyterian Hospital here.

2023 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU)

The 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) brought together members of the cancer care and research community to share new, innovative findings in the study, diagnosis, and treatment of GU malignancies. This year, ASCO GU was held in a hybrid format, taking place live in San Francisco from February 16-18, as well as virtually online.

A number of members of the Weill Cornell Medicine (WCM) Genitourinary (GU) Oncology Program presented or were involved with new research findings shared at the conference, as well as trial-in-progress updates for some of the clinical trials currently underway and open to accrual at Weill Cornell Medicine and NewYork-Presbyterian Hospital (NYP).

Our team’s contributions included both scientific and treatment advancements that are leading the way for more targeted therapies and improved outcomes for patients, as well as current trial-in-progress updates on ongoing studies.

Some of our the highlights include Dr. Scott Tagawa presenting on a combination treatment of PSMA-targeted therapy and hormonal therapy for certain patients with prostate cancer, Dr. Jones Nauseef presenting details on two different Weill Cornell Medicine studies involving an investigational therapy for metastatic castration-resistant prostate cancer and a collaboration genomic alterations project, and Dr. Cora Sternberg’s involvement with two clinical trials for prostate cancer and bladder cancer which had follow up results presented.

Two of our Hematology & Oncology Fellows also presented research updates from Weill Cornell Medicine studies. Dr. Joseph Thomas shared insights from demographic patient data for those treated on prostate-specific membrane antigen (PSMA)-targeted radionuclide clinical trials and Dr. Michael Sun presented on an investigational treatment combination for metastatic prostate cancer.

Additionally, Dr. David Nanus served on an expert panel for a session on clinical decision-making for prostate cancer, “Novel Guidelines for PSMA PET Staging of Disease: When to Follow and When to Not.”

Read more specifics below on our various team members’ involvement and research from the conference.

Prostate Cancer

Dr. Scott Tagawa presented exciting new research from Weill Cornell Medicine/NewYork-Presbyterian Hospital showing that a unique combination of PSMA-targeted therapy and hormonal therapy delayed metastases in a subset of patients with prostate cancer. 

A phase I/II clinical trial evaluating the investigational therapy 225Ac-J591 is underway at Weill Cornell Medicine for metastatic castration-resistant prostate cancer. Dr. Jones Nauseef explains the study aims which were presented as part of a trial-in-progress update: https://bit.ly/3XwUE02. This trial, which enrolls patients whether or not they have previously received 177Lu-PSMA, is ongoing.

Results from a phase 3 clinical trial showed improved overall survival in metastatic hormone-sensitive prostate cancer patients receiving darolutamide, androgen-deprivation therapy (ADT) and chemotherapy. Dr. Cora Sternberg shared takeaways from this research which led to the United States Food and Drug Administration (FDA) approval of this combination in August 2022: https://bit.ly/3xkfQeO

Dr. Timothy McClure explains a focal therapy prostate cancer treatment that is being evaluated in a clinical trial at Weill Cornell Medicine in combination with lower-dose radiotherapy: https://bit.ly/3E38YXi

Weill Cornell Medicine Hematology & Oncology Fellow Dr. Joseph Thomas shared details from a research registry analyzing demographic patient data for those treated on prostate-specific membrane antigen (PSMA)-targeted radionuclide clinical trials: https://bit.ly/3xsFVbD

Dr. Himanshu Nagar shared information about an ongoing phase 2 clinical trial comparing 4 weeks to 2 weeks of MRI-guided radiotherapy after prostate cancer surgery: https://bit.ly/3HZk14W. The SHORTER trial is currently open to enrollment at Weill Cornell Medicine/NewYork-Presbyterian Hospital.

Weill Cornell Medicine Hematology & Oncology Fellow Dr. Michael Sun shared preliminary results from Weill Cornell Medicine research evaluating a treatment combination of immunotherapy, anti-androgen medication, and PSMA-targeted radionuclide therapy for men with metastatic prostate cancer: https://bit.ly/3YKBxk4. This trial has entered a randomized phase and is enrolling patients.  

Dr. Ariel Marciscano breaks down Weill Cornell Medicine research studying irradiated prostate cancer tumors in an effort to analyze and understand the changes in the tumor and microenvironment after radiation treatment: https://bit.ly/40YDVWu https://bit.ly/3I0CBtj

Members of the Weill Cornell Medicine Englander Institute for Precision Medicine collaborated with the New York Genome Institute and genomic company Isabl to identify both known and unexpected genomic alterations in prostate cancer patients. Dr. Jones Nauseef shares insights: https://bit.ly/3xk21NC

A Weill Cornell clinical trial led by Dr. Himanshu Nagar was presented comparing two stereotactic body radiation therapy (SBRT) sessions to five SBRT sessions for prostate cancer: https://bit.ly/3E6erMS.

Weill Cornell Medicine Urology resident Dr. Alec Zhu discusses new Weill Cornell Medicine research he presented comparing cryoablation treatment outcomes between men with MRI-visible and MRI-invisible prostate cancer. https://bit.ly/3YQPcpG

Bladder Cancer

Dr. Cora Sternberg breaks down long-term follow-up results on a clinical trial evaluating avelumab as maintenance therapy for bladder cancer: https://bit.ly/3XvsyC8

Dr. Himanshu Nagar shares more about a clinical trial comparing immunotherapy alone to immunotherapy plus radiation therapy for bladder cancer. https://bit.ly/3E38YXi. This trial is open across the country, with patients receiving pembrolizumab with or without radiation.

Additionally, updates to three cohorts of the TROPHY-U-01 study evaluating the antibody-drug conjugate sacituzumab govitecan were presented by a team of authors including Drs. Tagawa and Sternberg at Weill Cornell Medicine. Cohort 1 of the study enrolled patients with progressive advanced urothelial carcinoma (UC) despite platinum chemotherapy and immune checkpoint inhibitors. Initial results led to an accelerated approval by the U.S. Food and Drug Administration (FDA). In an update presented at GU ASCO 2023, the research demonstrated that efficacy was maintained and no new toxicity signals emerged despite longer follow up. In Cohort 2, patients with advanced UC who were not candidates for cisplatin or carboplatin chemotherapy following immune checkpoint inhibitors received sacituzumab govitecan which demonstrated a 32% objective response rate. Cohort 3 enrolled patients with advanced UC following platinum chemotherapy, treating them with sacituzumab govitecan and pembrolizumab, leading to a 41% overall response rate. Ongoing enrollment is testing this drug in earlier lines of therapy with different combinations. Dr. Scott Tagawa spoke about the TROPHY-U-01 study, as well as other noteworthy studies from the conference, on VJ Oncology’s GU Cancer Sessions podcast. Listen here.

The Weill Cornell Medicine GU Oncology Program is dedicated to advancing genitourinary cancer research, improving clinical outcomes, and enhancing the quality of life for all those affected by these diseases. Our team of physicians and scientists continue to conduct research throughout the year aimed at enhancing the treatment possibilities and understanding of how we can best manage and tackle GU cancers.