FOLH1 positive

Finally, in vivo testing of PSMA TriKE showed improved tumor control and survival of mice as compared to IL-15 and untreated control groups. In conclusion, PSMA TriKE demonstrates potential as a new therapy for advanced prostate cancer by providing additional signals to NK cells to maximize their anti-tumor potential in prostate cancer, especially in the setting of a hostile TME.

Although the patient had experienced massive progression before the first cycle of B-OT-PRLT, he survived for an additional 12 months. This case supports the hypothesis that B-OT-PRLT could overcome radiation resistance in prostate cancer patients who do not initially respond to 177Lu- or 225Ac-PRLT.

P3, N=1145, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting

Artificial-intelligence-based analysis of baseline PSMA PET/CT images may improve patient selection. Validation of these findings on larger cohorts is warranted.

P3, N=1126, Recruiting, Novartis Pharmaceuticals | Active, not recruiting --> Recruiting

P1/2, N=144, Active, not recruiting, Barinthus Biotherapeutics | Recruiting --> Active, not recruiting

The novel ATC successfully controlled the growth of PSMA (+) tumors in preclinical settings with minimal systemic toxicities. The therapeutic efficacy and favorable safety profile of novel 5D3(CC-MLN8237)3.2 ATC demonstrates their potential use as a theranostic against aggressive PC.

P=N/A, N=174, Completed, Insel Gruppe AG, University Hospital Bern | Active, not recruiting --> Completed

Increased prostatic PSMA uptake on PET might be estimated based on T2 MRI alone. Further investigation with larger cohorts and external validation is needed to assess whether PSMA uptake can be predicted accurately enough to help in the interpretation of mpMRI.

P1, N=24, Recruiting, The Netherlands Cancer Institute | N=18 --> 24 | Trial completion date: Dec 2023 --> Jul 2025 | Trial primary completion date: Sep 2023 --> Jul 2025

P=N/A, N=100, Active, not recruiting, Insel Gruppe AG, University Hospital Bern | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Nov 2024 | Trial primary completion date: Jun 2023 --> May 2024

P1/2, N=26, Recruiting, FutureChem | Phase classification: P2a --> P1/2 | Trial completion date: Aug 2024 --> Jun 2025 | Trial primary completion date: Aug 2024 --> Jun 2025

PSMA expression in human, macaque, and marmoset prostates was determined by immunohistochemistry, employing an antibody with validated cross-species reactivity in a PSMA-positive control tissue; kidney. We newly discover that the common marmoset endogenously expresses PSMA in non-diseased prostate, similar to humans, and thus may be a valuable preclinical model for researchers studying PSMA.

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.

The presence of 68Ga-PSMA-11 PET/CT-positive findings in patients after radical prostatectomy and an undetectable PSA had a low predictive value for future progression. The interpretation of 68Ga-PSMA-11 PET/CT should always include a complex assessment of the clinical setting-the risk group, PSA value and degree of PSMA accumulation in the lesions. In these situations, further clarification of PSMA-positive findings is appropriate before deciding to change treatment.

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).

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.

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.

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.

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