Thursday, November 12, 2026
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At ESMO 2026, the PROMPT matched tissue-and-plasma series of 301 patients with metastatic castration-resistant prostate cancer reported that plasma ctDNA detected 50 of 61 patients with a BRCA1/2 or other HRR mutation and added 4 patients beyond tissue sequencing, with matched leukocyte DNA used to separate clonal hematopoiesis.
UroToday
On July 31, 2026, the FDA approved lutetium Lu 177 vipivotide tetraxetan with an androgen-receptor pathway inhibitor for PSMA-positive metastatic androgen-pathway-naive or -sensitive prostate cancer, with patients selected using Locametz or another approved PSMA PET product; in PSMAddition (1,144 patients) radiographic progression-free survival HR was 0.72 and median radiographic progression-free survival was not reached in either arm.
U.S. FDA
In a biomarker analysis of the phase 2 COMRADE trial presented at ASCO GU 2026, undetectable ctDNA at cycle 2 day 1 was associated with longer radiographic progression-free survival than detectable ctDNA (median 9.9 versus 2.7 months; HR 0.47) among 94 analyzed patients with bone-dominant metastatic castration-resistant prostate cancer.
UroToday
On June 12, 2026, the FDA approved capivasertib with abiraterone and prednisone for PTEN-deficient metastatic androgen-pathway-naive or -sensitive prostate cancer, and approved the VENTANA PTEN (SP218) RxDx Assay, which calls PTEN deficiency when at least 90% of viable malignant cells have no specific cytoplasmic staining; in CAPItello-281 (1,012 patients) median radiographic progression-free survival was 33.2 versus 25.7 months (HR 0.81), and overall survival was immature.
U.S. FDA
The FDA companion-diagnostic list dated May 27, 2026 includes FoundationOne CDx (P170019/S060) and FoundationOne Liquid CDx (P190032/S029) to identify homologous-recombination-repair gene alterations for talazoparib plus enzalutamide in metastatic castration-resistant prostate cancer.
U.S. FDA
At the NCCN 2026 Annual Conference, faculty reported that ADT plus niraparib and abiraterone is listed for BRCA2-mutated metastatic androgen-pathway-sensitive prostate cancer, as useful in certain circumstances for high-volume disease and as a category 2B option for low-volume disease.
The ASCO Post
The NCCN 2026 prostate cancer update presented at the NCCN Annual Conference adds a table of FDA-cleared PET imaging tracer studies, in a discussion that noted prior registration trials used conventional imaging rather than PSMA PET.
The ASCO Post
On May 11, 2026, the FDA approved the Atellica IM free PSA II assay to measure free PSA with a total PSA assay in men 50 years and older whose total PSA is 4 to 10 ng/mL and whose digital rectal exam is not suspicious for cancer, as an aid in distinguishing prostate cancer from benign prostatic disease.
U.S. FDA
The ESMO clinical practice guideline on advanced and metastatic prostate cancer, approved by the ESMO Guidelines Committee in January 2026, recommends genomic testing for BRCA1, BRCA2, CDK12, and PALB2 in all patients with castration-resistant prostate cancer, ideally before the first treatment for metastatic CRPC.
Annals of Oncology
Faculty at the NCCN 2026 Annual Conference described a new prostate-guideline pathway for metastasis-directed therapy in metachronous oligometastatic androgen-pathway-sensitive disease, including metachronous low-volume M1 disease.
The ASCO Post