Metastatic Prostate Cancer Clinical Trial Pipeline Expands with Multiple New Studies

Multiple pharmaceutical companies have initiated new clinical trials for metastatic castration-resistant prostate cancer in February 2026, expanding a pipeline that now includes over 180 companies developing more than 200 therapies for the advanced disease.

On February 12, 2026, Amgen announced a phase 3, open-label, multicenter, randomized study of Xaluritamig plus Abiraterone versus investigator's choice in participants with chemotherapy-naïve metastatic castration-resistant prostate cancer.

On February 11, 2026, Kyntra Bio initiated a study to evaluate the safety, efficacy, tolerability, and pharmacokinetics of FG-3246, a cluster of differentiation 46 (CD46) targeting antibody-drug conjugate (ADC), in the treatment of participants with mCRPC who have progressed following treatment with one prior second-generation androgen receptor signaling inhibitor (ARSI) in any setting and no prior taxane therapy in the mCRPC setting.

On February 9, 2026, Fusion Pharmaceuticals Inc. announced a study designed to investigate the efficacy, safety and tolerability of FPI-2265 (225Ac-PSMA-I&T) in combination with Olaparib in participants with mCRPC. The dose optimization Phase 2 part will be investigating the safety, tolerability, and anti-tumor activity of novel dosing regimens of FPI-2265 and Olaparib in participants with metastatic castration-resistant prostate cancer.

On February 9, 2026, Novartis Pharmaceuticals conducted a Phase I/II, open-label, global, multicenter study assessing the safety and efficacy of the combination of tulmimetostat (DZR123) and JSB462 (luxdegalutamide) versus standard of care in participants with progressive metastatic castrate resistant prostate cancer (mCRPC).

The pipeline depicts a robust space with 180+ active players working to develop 200+ pipeline therapies for metastatic hormone refractory prostate cancer treatment. Leading companies include Lantheus, Merck, Exelixis, Zenith Epigenetics, CellCentric, Karyopharm Therapeutics, Janux Therapeutics, Pfizer, Tavanta Therapeutics, Telix Pharmaceuticals, Jiangsu HengRui Medicine, SOTIO, Antev Ltd., Syntrix Pharmaceuticals, Regeneron Pharmaceuticals, Madison Vaccines, Phosplatin Therapeutics, MacroGenics, RedHill Biopharma, and Xencor.

Promising therapies in development include Enzalutamide, Patupilone, Prednisone, Docetaxel, Zactima (vandetanib), MDX-010, Denosumab, and RAD001. The pipeline covers drug profiles at both clinical and nonclinical stages, with therapeutics assessment by product type, stage, route of administration, and molecule type.

PNT2002, developed by Lantheus, is a radioconjugate composed of a human prostate-specific membrane antigen (PSMA)-targeting ligand conjugated to the beta-emitting radioisotope lutetium Lu 177 (177Lu), with potential antineoplastic activity. Upon administration of lutetium Lu-177 PNT2002, the PNT2002 moiety targets and binds to PSMA-expressing tumor cells.

Metastatic hormone-refractory prostate cancer (mHRPC), also known as metastatic castration-resistant prostate cancer (mCRPC), is an advanced stage of prostate cancer in which the disease continues to progress despite the suppression of testosterone to castrate levels. Initially, prostate cancer growth is typically driven by androgens, and hormone therapy is effective in slowing or stopping the disease. However, in mHRPC, cancer cells adapt and continue to grow even in the low-androgen environment. The cancer has also spread beyond the prostate gland to distant sites, most commonly bones and lymph nodes. This stage is associated with more aggressive behavior, increased symptom burden, and limited treatment options, requiring systemic therapies aimed at prolonging survival and improving quality of life.