TEST:

Decipher Prostate Cancer Test

18F-rhPSMA-7.3-PET/MRI can detect occult higher risk disease in men who are otherwise candidates for AS or FT. The scan prompted major changes in management and increased confidence in the final treatment strategy.

P=N/A, N=91, Recruiting, NYU Langone Health | Trial completion date: Nov 2027 --> Dec 2029 | Trial primary completion date: Nov 2025 --> Dec 2027

26 clinical impact evidence studies and four health economic evaluation studies were included. Most clinical studies indicated that genomic tests reclassified patients' risk predictions into both lower- and higher-risk groups. The reclassification outcomes influenced patients' treatment decisions between active surveillance and radical treatment. The prognostic value of the genomic tests was validated in terms of biopsy upgrade, metastasis and death. The limited number of health economic studies reported that the Oncotype DX Prostate Score and ProMark were cost-effective, while the Prolaris was cost-saving in the US but not in Canada. The evaluation of the Decipher Genomic Classifier at the time of diagnosis was not available. More long-term clinical evidence is needed, as are updated health economic evaluations, to determine the cost-effectiveness of integrating genomic risk stratification into prostate cancer treatment decision-making in clinical practice.

Additionally, the review addresses key genetic alterations implicated in prostate carcinogenesis, including mutations in BRCA1/2, HOXB13, and PTEN deletions, as well as changes in the androgen receptor pathway. By evaluating recent advancements and applications of these biomarkers, this review aims to enhance understanding of their role in improving early diagnosis, prognosis, and personalised management of prostate cancer.

This study represents the first prospective validation of GC performance in predicting early 2-year BCR in both AAM and White men. The findings provide strong evidence supporting the integration of the GC into clinical practice guidelines to improve risk stratification and management of AAM with early-stage PCa.

Ultimately, future research exploring whether C. acnes is a biomarker, bystander, or bona fide driver of PCa, and its potential role in personalised diagnostics are crucial to advance the field and unravel the predictive and therapeutic value of C. acnes. Clarifying this relationship will advance our understanding of microbiome-cancer dynamics and could help inform innovative early detection and screening strategies that improve patient care.

These findings suggest integration of genomic and clinicopathologic risk may lead to more nuanced risk assessment in prostate cancer and may help individualize treatment consideration.

Unfavourable histology was associated with higher Decipher scores and increased BCR risk. The addition of the histology category improved BCR prediction in a multivariable model.

P2, N=324, Active, not recruiting, NRG Oncology | Trial primary completion date: Mar 2026 --> Mar 2025

Patients with GC low-risk and PSC-LD csPCa may represent the ideal subgroup for FT. Prospective validation in a large cohort is warranted.

A DGC score >0.85 delineates a distinct subgroup with markedly adverse oncologic outcomes. Recognition of this VHR category refines postoperative assessment and supports personalized adjuvant or salvage therapy.

Rationale: The mode of action of [177Lu]Lu-PSMA-617 (LuPSMA) therapy is not fully understood and a relevant fraction of patients show treatment failure...In treatment-naive patient samples, PD-L2 expression was associated with unfavorable, whereas M1/M0 macrophages with favorable outcomes, which might indicate that immune checkpoint inhibition could be a combination partner of LuPSMA therapy. In patient biopsy samples acquired after the start of systemic treatment, AR gene expression and DNA repair signatures appear to be significantly altered and PD-L2 became a protective marker.