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 May 15, 2026, the FDA approved atezolizumab and atezolizumab/hyaluronidase as adjuvant treatment for adults with muscle-invasive bladder cancer after cystectomy who have ctDNA molecular residual disease on an FDA-authorized test, and approved Signatera CDx to select those patients; in IMvigor011 median disease-free survival was 9.9 versus 4.8 months (HR 0.64) and median overall survival was 32.8 versus 21.1 months (HR 0.59).
U.S. FDA
In the phase 3 IMvigor011 trial published in NEJM, 250 of 761 monitored patients with muscle-invasive bladder cancer tested ctDNA-positive after cystectomy and were randomized to atezolizumab or placebo, with median disease-free survival of 9.9 versus 4.8 months (HR 0.64) and median overall survival of 32.8 versus 21.1 months (HR 0.59); persistently ctDNA-negative patients were not treated on study and had a 95% disease-free survival at 1 year.
New England Journal of Medicine
On September 24, 2026, the FDA approved belzutifan with lenvatinib for adults with advanced clear-cell renal cell carcinoma after a PD-1 or PD-L1 inhibitor; versus cabozantinib, median progression-free survival was 14.6 versus 10.6 months (HR 0.74), while the final overall survival comparison was not statistically significant (HR 0.85).
U.S. FDA
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
In a 66-patient retrospective series presented at ASCO GU 2026, baseline Signatera ctDNA positivity before curative-intent treatment for urothelial carcinoma was associated with shorter recurrence-free survival (HR 5.15; 95% CI 1.41 to 18.78).
Journal of Clinical Oncology
An ASCO GU 2026 proof-of-concept series of 33 ctDNA samples from 21 patients with germ cell tumors, most of them marker-negative, reported 100% concordance between ctDNA detection and radiologic or pathologic disease status across the treatment phases assessed.
Journal of Clinical Oncology
Among 64 patients with ctDNA drawn before primary retroperitoneal lymph node dissection, an ASCO GU 2026 analysis reported sensitivity of 88% and specificity of 85% for germ cell tumor in the non-seminoma subgroup of 37 patients; seminoma specificity could not be estimated because every seminoma specimen contained tumor.
Journal of Clinical Oncology
An ASCO GU 2026 retrospective series of patients with testicular cancer who had at least one tumor-informed ctDNA result reported that, in that chart review, ctDNA was more sensitive and specific than serum tumor markers and imaging for residual disease and recurrence.
Journal of Clinical Oncology
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
A multicenter series of 77 patients with stage I to IV renal cell carcinoma, published in JCO Oncology Advances on January 21, 2026, found that Signatera ctDNA positivity in the molecular-residual-disease window was associated with inferior recurrence-free survival in the landmark analysis (HR 18; 95% CI 4.9 to 67).
JCO Oncology Advances
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
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
On July 10, 2026, the FDA extended perioperative pembrolizumab, or pembrolizumab and berahyaluronidase alfa-pmph, with enfortumab vedotin to adults with muscle-invasive bladder cancer who are candidates for cystectomy, including those eligible for cisplatin; in KEYNOTE-B15/EV-304 (808 patients) event-free survival HR was 0.53 and overall survival HR was 0.65 versus neoadjuvant gemcitabine and cisplatin.
U.S. FDA
In 110 patients with advanced urothelial carcinoma treated with enfortumab vedotin with or without pembrolizumab, an ASCO 2026 analysis of serial Signatera testing associated ctDNA positivity after 12 weeks with worse progression-free survival (HR 36.8) and overall survival (HR 17.7).
Journal of Clinical Oncology
A preliminary ASCO GU 2026 report from MONSTAR-SCREEN-3, with results available for 16 of 30 enrolled patients with resectable renal cell carcinoma, found baseline ctDNA in 16 of 16 evaluable patients using a tumor-informed whole-genome assay, including 9 of 16 below 100 parts per million.
Journal of Clinical Oncology
The MolDX billing article A58434, in the revision effective January 1, 2026, lists Signatera for progression, recurrence, or relapse testing in muscle-invasive bladder cancer.
CMS MolDX
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
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
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
On June 12, 2026, the FDA approved belzutifan with pembrolizumab, or with pembrolizumab and berahyaluronidase alfa-pmph, as adjuvant treatment for adults with clear-cell renal cell carcinoma at intermediate-high or high risk of recurrence after nephrectomy, or after nephrectomy and resection of metastases; in LITESPARK-022 (1,841 patients) disease-free survival HR was 0.72 and median disease-free survival was not reached in either arm.
U.S. FDA
On May 28, 2026, the FDA approved durvalumab with BCG for adults with BCG-naive high-risk non-muscle-invasive bladder cancer, based on POTOMAC (1,018 patients), where durvalumab plus BCG induction and maintenance improved investigator-assessed disease-free survival versus BCG alone (HR 0.68; median not reached in either arm).
U.S. FDA
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
At the NCCN 2026 Annual Conference, faculty reported that ipilimumab plus nivolumab moved from category 2A to a category 1 preferred first-line regimen for clear-cell renal cell carcinoma.
The ASCO Post
Faculty at the NCCN 2026 Annual Conference said subsequent therapy for renal cell carcinoma now includes lenvatinib as a category 2A option in defined settings, while axitinib plus pembrolizumab, cabozantinib plus nivolumab, and lenvatinib plus pembrolizumab moved from category 2A to 2B, and axitinib plus avelumab was removed.
The ASCO Post
At the NCCN 2026 Annual Conference, enfortumab vedotin plus pembrolizumab was described as the sole preferred first-line regimen in the bladder cancer guideline for locally advanced or metastatic disease.
The ASCO Post
Faculty at the NCCN 2026 Annual Conference described perioperative durvalumab with gemcitabine and cisplatin as the preferred treatment for cisplatin-eligible muscle-invasive bladder cancer.
The ASCO Post
On November 21, 2025, the FDA approved pembrolizumab, or pembrolizumab and berahyaluronidase alfa-pmph, with enfortumab vedotin as neoadjuvant treatment and adjuvant treatment after cystectomy for adults with muscle-invasive bladder cancer who are ineligible for cisplatin; in KEYNOTE-905/EV-303 (344 patients) event-free survival HR was 0.40 and overall survival HR was 0.50 versus surgery alone.
U.S. FDA