Latest Prostate Cancer News

Telix Pharmaceuticals has achieved a key milestone with its next-generation prostate cancer imaging agent, Gozellix, receiving a permanent HCPCS code from U.S. Medicare. This paves the way for broader reimbursement and market adoption starting October 2025.

Radiopharm Theranostics has inked a clinical supply agreement with Cyclotek to support its Phase 1 trial of RAD 402, a novel radiotherapeutic targeting prostate cancer, set to commence in Australia in late 2025.

Clarity Pharmaceuticals has partnered with SpectronRx to manufacture and distribute its lead prostate cancer diagnostic, Cu-64 SAR-bisPSMA, at commercial scale across the US. This agreement sets the stage for a seamless launch pending FDA approval.

Clarity Pharmaceuticals’ novel PET imaging agent Cu-SAR-Bombesin demonstrated safety and effectiveness in detecting prostate cancer recurrence missed by standard scans in its Phase II SABRE trial. The agent identified lesions in about one-third of patients with negative or equivocal standard imaging.

Telix Pharmaceuticals showcased its global theranostic radiopharmaceutical portfolio, highlighting FDA approvals, clinical progress, and a robust commercial expansion plan at its 2025 Investor Day.

Clarity Pharmaceuticals has successfully imaged the first patient in its pivotal Phase III AMPLIFY trial for Cu-SAR-bisPSMA, a next-generation diagnostic agent targeting recurrent prostate cancer. This milestone sets the stage for potential FDA approval and broader clinical adoption.

Clarity Pharmaceuticals has initiated its second registrational Phase III AMPLIFY trial for the Cu-SAR-bisPSMA PET imaging agent targeting biochemical recurrence of prostate cancer. The multi-centre study aims to generate critical data supporting FDA approval and could redefine prostate cancer diagnostics.

Clarity Pharmaceuticals reports a robust cash position and strategic refocus on its lead prostate cancer asset, Cu-SAR-bisPSMA, supported by multiple FDA Fast Track designations and advancing clinical trials.

Telix Pharmaceuticals has gained UK MHRA approval for Illuccix, its advanced prostate cancer PET imaging agent, promising to alleviate supply shortages and improve diagnostic accuracy across the UK.

Clarity Pharmaceuticals has expanded its breast cancer pipeline by introducing 64/67Cu-SAR-trastuzumab, supported by promising pre-clinical data and a new supply agreement for trastuzumab, aiming to address the unmet needs in HER2-positive breast cancer treatment.

Clarity Pharmaceuticals reports robust progress in its SECURE trial and secures FDA Fast Track Designation for its diagnostic agent 64Cu-SAR-bisPSMA, underpinning its growth and innovation in prostate cancer treatment.

Invion Limited has marked significant progress in its cancer treatment pipeline, dosing the first patient in a pivotal skin cancer trial and reporting encouraging prostate cancer results, while securing fresh funding to support ongoing development.