August, 2023

Clinical Trials News and Updates

FDA Approves the First Combination Medicine for Treating Metastatic Castration-Resistant Prostate Cancer

The U.S. Food and Drug Administration (FDA) has approved AKEEGA^TM, a groundbreaking combination of two drugs, abiraterone and niraparib. This innovative treatment uses a PARP inhibitor, which stops a protein from fixing damaged DNA in cancer cells and, thereby, destroys the cancer cells. Data from a PHEN-supported clinical trial, MAGNITUDE, has revealed that AKEEGA™, when used alongside the medication prednisone, results in a 47% reduction in disease progression. These results surpass the outcomes of using abiraterone and prednisone separately. This approval significantly expands the treatment options available for prostate cancer patients with advanced disease.

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FDA Grants Priority Review for XTANDI for Patients With Recurrent Non-Metastatic Castration-Sensitive Prostate Cancer (nmCSPC)

The FDA’s decision to quickly review the use of XTANDI, a second-generation anti-deprivation therapy, is based on the results from the EMBARK trial. This clinical trial evaluated patients with high-risk recurring nmCSPC across three study groups. The first study group used XTANDI plus the leuprolide injection treatment for advanced prostate cancer. The second study group used the leuprolide injection alone while the third study group used XTANDI alone. The XTANDI plus leuprolide group demonstrated a statistically significant 58% decrease in the risk of metastasis or death compared to the leuprolide-alone group.

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Patient Benefits of Participating in Clinical Trials:

● Clinical trials offer additional treatment options

● Patients receive expert medical care during clinical trials

● Treatment is often provided at minimal or no cost to patients

● Patients are among the first to benefit from a new therapy

● Patients contribute to the discovery of new treatments

Patient Story

Sherman Womack, a retired firefighter, began his courageous battle with prostate cancer at the age of 52 when diagnosed in September 2004. Prostate cancer is a disease that, unfortunately, runs in his family. In 2005, shortly after joining PHEN, Sherman underwent a radical prostatectomy, marking the beginning of a treatment journey that spanned nearly two decades. His treatments included therapies such as external beam radiation and anti-androgen therapies. Finally, Sherman participated in the Pluvicto clinical trial, which he completed in June 2023. Tragically, prostate cancer has been a recurring ailment in the Womack family, affecting multiple close relatives. Despite these challenges, Sherman’s perseverance and involvement with PHEN have made him a beacon of hope and an inspiration to many facing similar health challenges.

To hear about Sherman’s story live, register for PHEN’s 19th Annual African American Prostate Cancer Disparity Summit. Sherman will participate in the third session on September 20, 2023, starting at 1:00 p.m.

PHEN Clinical Trials Highlights

PROTEUS

The PROTEUS study is a Phase 3 clinical trial assessing subjects diagnosed with high-risk, localized, or locally advanced (moved past the covering of prostate gland) prostate cancer and are candidates for radical prostatectomy (surgical removal of the prostate gland).

Patient Summary

TAMARACK

Tamarack is a clinical trial studying how well a new generation of targeted drugs called antibody-drug conjugates (ADCs) precisely deliver small amounts of chemotherapy directly to cancer cells.

Patient Summary

AMG509

AMG509 is a clinical trial for subjects who have mCRPC and have not responded to either abiraterone acetate or enzalutamide treatments (but not both) and to taxane-based chemotherapy.

Patient Summary

Investigational Drug PF-06821497

This study is looking to see if an investigational oral medicine in combination with enzalutamide is safe and effective for the treatment of metastatic castration resistant prostate cancer (mCRPC).

Patient Summary

WHAT IS NEW IN CLINICAL TRIALS?

Title: Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants with Prostate Cancer

NCT Number: NCT05803941

Sponsor: Novartis

Brief:

The purpose of this post-marketing study is to further characterize the long-term results of known or potential risks of lutetium (177Lu) vipivotide tetraxetan, which is also known as Lu-PSMA-617 or 177Lu-PSMA-617 and, hereinafter, referred to as AAA617.

The study also seeks to explore any other serious adverse reaction(s) that may arise over the long term in adults with prostate cancer who received at least one dose of AAA617 in interventional, Phase I-IV Novartis-sponsored clinical trials.

PHEN's Clinical Trial Sponsors

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