FOLH1 positive

VTX-1 enables isolation of CTCs and plasma exosomes from a single blood draw and can be used for detecting AR-V7 and PSMA mRNA in both CTCs and cfRNA in patients with mCRPC and resistance to ARIs. This technology facilitates combining RNA measurements in CTCs and exosomal cfRNA for future studies to develop potentially clinically relevant cancer biomarker detection in blood.

P2, N=400, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences | N=100 --> 400

PSMA-derived split function demonstrated a high correlation with renal function assessed on diuretic 99mTc-MAG3 renograms. PET-derived split renal function may, therefore, be considered an alternative to diuretic renogram-based split function. Furthermore, both 99mTc-MAG3 and 68Ga-PSMA PET/CT studies identified morphological renal abnormalities such as hydronephrosis, shrunken and obstructed kidneys. This correlation underscores the potential utility of 68Ga-PSMA imaging as a valuable tool for assessing kidney morphology as an alternative to renogram split function in clinical practice.

P3, N=450, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting

The analytical validation utilizing Epic Sciences' liquid biopsy CTC platform demonstrated the potential to detect PSMA protein expression in CTCs from patients with mCRPC. This assay is positioned as an effective research tool to evaluate PSMA expression, heterogeneity, and therapeutic response in many ongoing clinical studies to target tumors that express PSMA.

P2/3, N=188, Completed, Novartis Pharmaceuticals | Recruiting --> Completed

P1, N=30, Completed, Telix International Pty Ltd | Recruiting --> Completed | N=50 --> 30 | Trial completion date: Sep 2024 --> Sep 2023 | Trial primary completion date: Mar 2024 --> Sep 2023

Our study confirmed that PSMA-positive TAV is a prospective diagnostic and prognostic biomarker for HCC. Co-expression of PSMA with PD-L1 may suggest potential crosstalk between the 2 proteins, likely regulating the tumor microenvironment.

P1/2, N=50, Recruiting, British Columbia Cancer Agency | Not yet recruiting --> Recruiting

P2, N=200, Active, not recruiting, Canadian Cancer Trials Group | Recruiting --> Active, not recruiting

This is the first study to introduce SARIFA as easy-and-fast-to-assess H&E-based biomarker in locally advanced PCa. SARIFA as the histopathologic correlate of a distinct tumor biology, closely related to lipid metabolism, could pave the way to a more detailed patient stratification and to the development of novel drugs targeting lipid metabolism in pT3a PCa. On the basis of this biomarker discovery study, further research efforts on the prognostic and predictive role of SARIFA in PCa can be designed.

P3, N=163, Completed, Mayo Clinic | Enrolling by invitation --> Completed | N=250 --> 163

P2, N=100, Recruiting, Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

At the same injected mass (5 nmol), the use of BQ0413 was more efficient in suppressing renal uptake than the use of PSMA-11. In conclusion, [Tc]Tc-BQ0413 is a promising probe for the visualization of PSMA-positive lesions using single-photon emission computed tomography (SPECT).

The PRIMORDIUM study aims to evaluate the intensification of treatment with apalutamide for patients assessed with PSMA-PET. From 198 enrolled patients with high-risk BCR, positive PSMA-PET was documented in 44% of patients at a median of 39 months after RP and a median PSA of 0.51 ng/mL, while negative PSMA-PET was observed in 56% of patients at a median of 26 months after RP and a median PSA of 0.35 ng/mL. In this analysis, all PSMA-PET-positive patients had locoregional lesion(s) and 10% also had distant lesion(s) on PSMA-PET.

This study provided the unique opportunity to describe real-world outcomes for late stage mCRPC patients treated with PSMA-RLT. The study design did not allow for a direct comparison between the two cohorts. Qualitatively, UKE patients were heavily pre-treated with extensive disease burden at the start of PSMA-RLT.

Quantitative image analysis of 18F-DCFPyL PET at BCR may be useful in predicting the subsequent bPFS. Given many patients were treated with MDT and/or ADT, clinical implication of the findings remains to be elucidated to guide treatment intensification based on findings on 18F-DCFPyL PET.

Eligible patients must have received prior therapy with either enzalutamide or abiraterone plus prednisone, and 1 line of prior taxane therapy or have refused or are ineligible for taxanes. Secondary endpoints include 5-year overall survival, tumor objective response rate, time to symptomatic skeletal event, progression free survival, and number of participants with treatment-related adverse events. Clinical trial information: NCT04876651.

Further, LNCaP spheroid growth was inhibited with the increasing activity. Overall, treatment efficacy was higher in LNCaP spheroids compared to monolayers, which can be explained by the difference in the resulting dose, among others.

P1/2, N=144, Recruiting, OncoC4, Inc. | Not yet recruiting --> Recruiting

P2, N=120, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting

PSMA-Mp can transfer PSMA and new phenotypic characteristics to the tumor microenvironment. The consequence of PSMA transfer to cells and increased secretion of vascular endothelial growth factor-A (VEGF-A), pro-angiogenic and pro-lymphangiogenic mediators, with increased 4E binding protein 1 (4EBP-1) phosphorylation.

These results support the use of [Lu]Lu-PSMA-617 as an alternative to cabazitaxel for PSMA-positive metastatic castration-resistant prostate cancer progressing after docetaxel. We did not find evidence that overall survival differed between the randomised groups. Median overall survival was shorter for men who were excluded because of low PSMA expression or 2-[F]FDG-discordant disease.

P3, N=1144, Active, not recruiting, Novartis Pharmaceuticals | Trial primary completion date: Jul 2025 --> Aug 2024

P2, N=100, Recruiting, Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori | Not yet recruiting --> Recruiting

P1/2, N=200, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting

The acquired material was suitable for next-generation sequencing-based gene panel diagnostics and did not show a BRCA1/2 mutation, thus PSMA radioligand therapy was initiated. Fine-needle aspiration cytology of lymph node metastases may be a viable option in evaluating further therapeutic alternatives.

P3, N=1144, Active, not recruiting, Novartis Pharmaceuticals | Trial primary completion date: Aug 2024 --> Jul 2025

P3, N=180, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting

P4, N=30, Not yet recruiting, Dana-Farber Cancer Institute

in renal cancer, positive PSMA-PET/CT is strongly correlated to the intensity of PSMA expression on immunohistochemistry in both ccRCC and chromophobe cancer. PSMA-PET/CT signal predicts a poor prognosis confirming its potential as an aggressiveness biomarker and providing paramount additional information influencing patient management.

P3, N=450, Not yet recruiting, Novartis Pharmaceuticals | Trial completion date: Dec 2029 --> Jun 2030 | Initiation date: Oct 2023 --> Mar 2024 | Trial primary completion date: May 2026 --> Jan 2028

P1/2, N=144, Not yet recruiting, OncoC4, Inc. | Phase classification: P2 --> P1/2 | N=90 --> 144 | Trial completion date: Dec 2026 --> Jun 2027 | Initiation date: Sep 2023 --> Dec 2023 | Trial primary completion date: Dec 2025 --> Jun 2026

P1, N=140, Recruiting, Bayer | Not yet recruiting --> Recruiting

Methods Forty-eight patients with metastatic CRPC treated with docetaxel followed by cabazitaxel were included in the study. The log-rank test result showed shorter OS after initiation of docetaxel treatment in patients with positive PSMA than in those with negative PSMA (median survival at observation, PSMA-positive group: 618 days; PSMA-negative group: 1187 days; P=0.05). Conclusions The expression of PSMA in CTCs was associated with OS after initiation of taxane-based chemotherapy in metastatic CRPC.

This post hoc analysis assessed the outcomes of 176 patients treated with PSMA PET guided salvage RT, proving it to be an effective method for treating both pelvic and extrapelvic recurrent PCa. Further investigation is needed to assess the full extent of patient outcomes in this population.

The 18F-DCFPyL PSMA PET local recurrences can provide detailed localization of prostate bed and seminal vesicle recurrences. Our data can inform contouring guidelines for salvage radiotherapy to the prostate bed, particularly when using anatomical landmarks to define cranio-caudal extent of target volumes. For target volume laterally, the medial wall of levator ani would encompass all prostate bed recurrences, and no seminal vesicles recurrences were seen at the medial border of the obturator internus muscle.

PET-PSMA is a powerful diagnostic tool that conditions significant changes in the therapeutic approach in those patients with occult biochemical recurrence with low PSA, changing the treatment in 75% of the cases when the study is positive.

ProstEVs is the first blood biomarker of tumor burden that can prognosticate the risk of disease recurrence in omPC patients treated with SABR. While biomarker-guided trials are warranted, our validation study strengthens the clinical value of ProstEVs for personalized radiation therapy.

In most cases with a negative histopathology from PSMA-RGS, lesions were FP on PSMA PET. Unspecific uptake should be considered in low PSMA-expressing lymph nodes at the distal external iliac arteries or outside the pelvis, especially if no PSMA-positive lymph nodes closer to the prostatic fossa are evident. Rarely, true positive metastases were missed by surgery or histopathology.

Recently, [Lu]Lu-PSMA-617 (Pluvicto) was approved by the FDA for radionuclide therapy...PET imaging using [Ga]Ga-P17-079 ([Ga]Ga-1) in the same mouse model displayed excellent images confirming the expected dual-targeting to PSMA-positive tumor and bone. Results suggest that [Lu]Lu-P17-079 ([Lu]Lu-1) is a promising candidate for further development as a hetero-bivalent radionuclide therapy agent targeting both PSMA expression and bone metastases for the treatment of prostate cancer.

This study emphasizes that upregulating dnTGFβRII and trTIM3 on the surface of T cells can potentially diminish the inhibitory effects of TGFβRII and TIM3.