Prostate Cancer Radioligand Therapy Developments

A new PSMA-targeted radioligand therapy, when administered before stereotactic body radiotherapy, more than doubled progression-free survival in patients with recurrent prostate cancer, extending it from 7.4 months to 17.6 months. This combination therapy reduced the risk of cancer returning, the need for hormone therapy, or death by 63%. Patients also experienced a significant delay in starting hormone therapy, with a median of 24.3 months compared to 14.1 months in the control group.

via UCLA Health

Bayer has announced promising results from its Phase I PAnTHa study of 225Ac-PSMA-Trillium, an investigational targeted alpha therapy for advanced metastatic castration-resistant prostate cancer. The study demonstrated significant antitumor activity, with a 62% PSA response rate and a 50% overall response rate across all doses, and notably, an 83% PSA50 response rate and 71% overall response rate at the 125 kBq/kg dose.

via biospace.com

New findings from the PSMAddition study, presented at the 2026 Genitourinary Cancers Symposium, indicate that Pluvicto (lutetium Lu 177 vipivotide tetraxetan) combined with androgen deprivation therapy (ADT) and an androgen receptor pathway inhibitor (ARPI) maintained quality-of-life outcomes in patients with metastatic hormone-sensitive prostate cancer. This was compared to ADT plus an ARPI alone, with a median follow-up of 23.6 months.

via OncoTherapy Network·novartis.com·urologytimes.com

Bayer presented data from its Phase I PAnTHa study of the investigational targeted alpha therapy 225Ac-PSMA-Trillium for advanced metastatic castration-resistant prostate cancer at the 2026 ASCO Genitourinary Cancers Symposium. The results support advancing this therapy to the next phase of development, positioning it as a strategic pillar in Bayer's precision oncology efforts for mCRPC patients.

via Business Wire·urotoday.com·auntminnie.com

Curium presented pharmacokinetics and dosimetry data for its investigational lutetium-177 zadavotide guraxetan at the ASCO GU 2026 symposium. The data from a substudy of the Phase 3 ECLIPSE trial showed projected mean cumulative renal doses remained low for PSMA-targeted radioligand therapy in metastatic castration-resistant prostate cancer patients.

via globenewswire.com·urotoday.com·businesswire.com

Novartis announced the construction of a new radioligand therapy (RLT) manufacturing facility in Denton, Texas, its fifth RLT site in the U.S., expected to be operational by 2028. New real-world data presented at the ASCO Genitourinary Cancers Symposium reinforce the earlier use of Pluvicto before chemotherapy for metastatic castration-resistant prostate cancer (mCRPC), showing a median progression-free survival (PFS) of 13.5 months in chemo-naïve patients. Additionally, researchers identified genetic mutations (TP53, PTEN, RB1) linked to inferior overall survival in Pluvicto-treated patients.

via UroToday·Novartis·Nasdaq

Novartis announced its intention to build a new radioligand therapy (RLT) manufacturing site in Denton, Texas, its fifth RLT facility in the U.S. The new 46,000-square-foot facility, expected to be operational by 2028, is part of Novartis's $23 billion investment in the U.S. and aims to expand their capacity for producing next-generation treatments.

via whtc.com·dallasinnovates.com·nasdaq.com

New real-world data presented at the ASCO Genitourinary Cancers Symposium reinforce the earlier use of Pluvicto before chemotherapy in metastatic castration-resistant prostate cancer (mCRPC), demonstrating a median progression-free survival (PFS) of 13.5 months in chemo-naïve patients. Separately, the Prostate Cancer Foundation announced a $10 million gift to launch the TACTICAL Award, which will focus on understanding and overcoming resistance to 177Lu-PSMA-617 (Pluvicto®).

via Novartis·Business Wire·mayoclinic.org

Researchers have identified that certain genetic mutations, including TP53, PTEN, and RB1, are linked to inferior overall survival in patients treated with Pluvicto (lutetium-177 PSMA-617) for advanced prostate cancer. A study involving 72 patients found these mutations may serve as prognostic biomarkers for treatment outcomes.

via AuntMinnie·novartis.com·news.mayoclinic.org

A meta-analysis of over 2500 patients presented at the Multidisciplinary Radiopharmaceutical Therapy Symposium showed that Pluvicto (Lu-177 PSMA-617) significantly improved progression-free survival (PFS) in advanced prostate cancer patients compared to standard treatment. The study found no increase in adverse events for patients receiving Pluvicto. Pooled results presented at the American Society for Radiation Oncology's symposium also indicated Pluvicto consistently prolongs PFS.

via AJMC·AuntMinnie.com

Eli Lilly has ceased development of three therapies, including a radioligand therapy (AC-225-PSMA-62) that was in a Phase I/II trial for prostate cancer. The decision to terminate the development was based on efficacy concerns, with safety not being a factor.

via clinicaltrialsarena.com

Curium Group, in collaboration with PeptiDream Inc. and PDRadiopharma Inc., has initiated a registrational clinical trial for 177Lu-PSMA-I&T in Japan. The first patient has been dosed in this Phase 2 trial, which will evaluate the efficacy of the treatment for patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).

via markets.businessinsider.com

Novartis announced that Pluvicto received MHRA approval in the UK on February 3, 2026, for a new indication. This expanded approval allows Pluvicto to be administered to eligible patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) earlier in their treatment pathway, specifically after progression on or after androgen receptor pathway inhibitor (ARPI) therapy and when delaying taxane-based chemotherapy is considered appropriate.

via novartis.com·labiotech.eu·ajmc.com·prostate-cancer-research.org.uk

The American Society of Clinical Oncology (ASCO) has released its first living guidelines for prostate cancer, which now allow for Pluvicto to be used before chemotherapy in patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Novartis is also pursuing an expanded label for Pluvicto to include patients in the pre-taxane chemotherapy setting.

via oncnursingnews.com·urologytimes.com·dana-farber.org·novartis.com·uclahealth.org

Soon Chun Hyang University Hospital Bucheon became the first in Incheon and western Gyeonggi Province to offer Pluvicto therapy for advanced prostate cancer.

via koreabiomed.com

Kai Tsao of Northwell Health Cancer Institute is scheduled to participate in a debate discussing the optimal timing for Lutetium-177 (Pluvicto) therapy in advanced prostate cancer. The discussion will focus on the potential advantages of earlier use of the radioligand therapy.

via oncodaily.com

The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Ilumira (lutetium (177Lu) chloride), a radiopharmaceutical precursor used in radioligand therapies.

via ema.europa.eu

UCLA Health has initiated the Phase 2 ANDROMEDA clinical trial to investigate combined precision radiation and targeted radioactive therapy for recurrent prostate cancer. The study will compare lutetium-177–PSMA-617 and actinium-225–PSMA-617.

via uclahealth.org