Telix Pharmaceuticals Limited announces that the first patient in the United States (U.S.) has been dosed in BiPASS, a Phase 3 trial to evaluate the use of Telix’s commercial PSMA-PET imaging agents, Illuccix and Gozellix in the initial prostate cancer diagnosis setting. The dose was administered under the supervision of Dr. Brian Mazzarella at Urology Austin and supplied by RLS Radiopharmacies.

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BiPASS is the first study designed to gain marketing authorization for Ga-PSMA-PET imaging in the pre-biopsy setting. The prospective, open-label Phase 3 trial will enroll 250 patients across sites in the U.S. and Australia. The study aims to determine whether combining MRI with Illuccix/Gozellix Ga-PSMA-11 PET can improve diagnostic accuracy and reduce unnecessary biopsies compared to current standard practice. Men with elevated PSA4 often proceed from an inconclusive MRI to template prostate biopsy. This procedure is stressful and unpleasant, can lead to complications5 and frequently proves to be of no benefit to the patient.

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In the U.S., more than one million prostate biopsies are performed annually, yet up to 75% are negative, and one in four patients declines the physician recommendation of receiving a biopsy. The objective of BiPASS is to demonstrate improved lesion detection and patient stratification by integrating non-invasive molecular Illuccix/Gozellix Ga-PSMA-11 PET imaging early in the diagnostic pathway, to enable biopsy de-escalation or, alternatively, greater biopsy precision when administered.

If the BiPASS study achieves its primary objectives, it could lead to a reduction in unnecessary biopsies, improved patient experience, and a significant expansion of access to precision imaging for patients with suspected prostate cancer, potentially increasing the use of Ga-PSMA-11 PET in a large new patient population.

Dr. Mazzarella, Vice President of Research for Urology America, said, “We’re excited to participate in the BiPASS trial at Urology Austin, which brings together promising technologies and emerging trends in patient care. If BiPASS is successful in meeting its primary endpoint, it could eliminate the need for biopsy—reducing risks, side effects, and costs—and improve decision-making for providers and patients.”

Kevin Richardson, Chief Executive Officer, Telix Precision Medicine, added, “Illuccix and Gozellix are already transforming how clinicians treat and manage prostate cancer. By initiating this trial, we are reinforcing Telix’s commitment to patient centricity, clinical innovation, and industry leadership—with the goal of eliminating invasive biopsy.”

Radiation Risks

Gallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.

ADVERSE REACTIONS

The safety of gallium Ga 68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMA-BCR studies, each receiving one dose of gallium Ga 68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.

In the VISION study, 1003 patients received one dose of gallium Ga 68 gozetotide intravenously with the amount of radioactivity 167.1 ± 23.1 MBq (4.52 ± 0.62 mCi). Adverse reactions occurring at ≥0.5% in patients with metastatic prostate cancer who received gallium Ga 68 gozetotide injection in the clinical study were fatigue (1.2%), nausea (0.8%), constipation (0.5%), and vomiting (0.5%).
Adverse reactions occurring at a rate of < 0.5% in the VISION study were diarrhea, dry mouth, injection site reactions, including injection site hematoma and injection site warmth and chills.

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Source- GlobeNewswire