JAMA Network Open published online on November 11, 2026 a prespecified secondary analysis of the nonrandomized phase 2 TRAP trial: plasma was tested with the previously validated prostate-directed PCF_SELECT panel before stereotactic body radiotherapy in men with metastatic castration-resistant prostate cancer and oligoprogression on abiraterone or enzalutamide. Of 77 evaluable patients (81 treated at 8 UK sites), 19 (24.7%) were ctDNA-positive. Six-month progression-free survival was 21.1% versus 58.3%, and median progression-free survival was 3.0 versus 7.8 months (log-rank P = .003; adjusted HR 2.18, 95% CI 1.21-3.94, P = .009). Median time to next therapy or death was 15.3 versus 29.6 months (adjusted HR 1.57, P = .20), and median overall survival was 27.2 versus 33.6 months (adjusted HR 2.24, P = .07). The trial was not randomized, so a prognostic association is not separated from a predictive one.
JAMA Network Open
NCT07927998 (PACER) is a recruiting, single-arm phase 2 MSK trial (estimated enrollment 25) of retifanlimab after definitive chemoradiation in people with anal squamous cell carcinoma who remain Signatera-positive, with the rate of ctDNA clearance at 12 weeks as the primary endpoint.
ClinicalTrials.gov
NCT07823322 (NEXERA-204) is an Incyte-sponsored, not-yet-recruiting, single-arm phase 2 study of INCA33890 in about 40 adults with Signatera-positive, microsatellite-stable stage II/III colorectal cancer after curative resection and chemotherapy, with ctDNA clearance at 3 months as the primary endpoint; Natera announced a clinical collaboration on this study on November 10, 2026.
Natera, Inc.
In a single-center series of 87 patients undergoing cytoreductive surgery for colorectal peritoneal metastases, postoperative ctDNA was detectable in 30 of 83 (36%) and was associated with shorter recurrence-free survival (HR 3.5), peritoneal recurrence-free survival (HR 3.1), and overall survival (HR 6.7); the abstract does not name the assay, and the paper is about peritoneal, not liver, metastases.
Annals of Surgical Oncology
A Natera press release dated November 5, 2026, describes a real-world SITC analysis of 424 patients on first-line immunotherapy for stage IV melanoma, kidney cancer, MSI-H colorectal cancer, or NSCLC: people with two consecutive negative Signatera results had 36-month overall survival of 93.2% versus 77.9% in all others (HR 0.24, P=0.0003), and among those complete molecular responders overall survival was 93.5% if immunotherapy continued and 89.4% if it stopped (P=0.42). These figures are from the company press release; the official SITC/JITC abstract was not retrieved.
Natera, Inc. company press release
Industry news: in its November 4, 2026, third-quarter earnings release, BillionToOne said Northstar Clear, a tissue-free, blood-only MRD test it describes as intended for all solid tumors, is planned to be commercially available on December 15, 2026, with initial colorectal cancer data to be compared with a tumor-informed assay.
Industry news
In the prospective PRECISION study of 118 eligible patients with resectable colorectal oligometastases, pretreatment Guardant360 genomic profiling and postoperative Guardant Reveal MRD were each independently associated with shorter recurrence-free survival (multivariable HRs 3.28 and 4.07); patients with both a poor genomic profile and postoperative MRD had the highest recurrence risk (RFS HR 13.28), and those with an optimal profile and undetected MRD had a 2-year RFS of 77.8%.
ESMO Open
Initial results from the prospective HER2-CR registry (NCT06663787) in 37 evaluable patients with long-term CR/PR on anti-HER2 therapy for HER2-positive metastatic breast cancer found that 129 of 142 plasma samples (91%) were negative on Signatera Genome and 30 of 37 patients (81%) were negative at every assessment; all 23 patients without radiographic residual disease remained ctDNA-negative, while persistent positivity was more often accompanied by progression.
ESMO Open
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
A JAMA Oncology analysis published online August 13, 2026, of 1,026 plasma samples from 159 patients in the c-TRAK TN surveillance cohort found that tissue-free ctDNA detection was associated with recurrence (HR 27.2; 95% CI 13.7 to 54.2), and median lead time to recurrence was 7.6 months with the tissue-free assay versus 7.1 months with a multivariant tumor-informed assay.
JAMA Oncology
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
ClinicalTrials.gov lists the observational TiMBER study (NCT07726602), led by OHSU, as recruiting from a June 29, 2026 start date to test whether Labcorp Plasma Detect ctDNA corresponds with recurrence after curative-intent treatment for muscle-invasive urothelial carcinoma.
ClinicalTrials.gov
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
In the phase 3 ALTAIR trial published in Nature Medicine on June 8, 2026, 243 patients with resected colorectal cancer who became tumor-informed ctDNA-positive without radiographic disease were randomized to trifluridine/tipiracil or placebo; median disease-free survival was 9.30 versus 5.55 months (HR 0.79; P = 0.107), so the primary endpoint was not met.
Nature Medicine
ClinicalTrials.gov lists NCT07401316, a diagnostic study led by Indiana University with Natera, as recruiting from a June 3, 2026 start date to measure the positive predictive value of ctDNA in high-risk stage I, stage II, and stage III germ cell tumors.
ClinicalTrials.gov
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 2026 NCCN kidney cancer discussion added a recommendation, for non-clear-cell renal cell carcinoma, to consider tumor genomic testing for clinical-trial eligibility.
The ASCO Post
