^
    14h
    Cabazitaxel +/- Carboplatin vs 177Lu-PSMA-617 in Metastatic Castrate-resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=44, Not yet recruiting, Case Comprehensive Cancer Center
    New P2 trial • Metastases
    |
    carboplatin • cabazitaxel • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    7d
    Post Marketing Study on Pluvicto in Korea (clinicaltrials.gov)
    P=N/A, N=278, Not yet recruiting, Novartis Pharmaceuticals | Trial completion date: Jul 2027 --> Mar 2029 | Initiation date: Oct 2024 --> May 2025 | Trial primary completion date: Jul 2027 --> Mar 2029
    Trial completion date • Trial initiation date • Trial primary completion date • Real-world evidence • Real-world
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    7d
    A Study to Learn How Safe the Study Treatment Actinium-225-macropa-pelgifatamab (BAY3546828) is, How it Affects the Body, How it Moves Into, Through and Out of the Body, and About Its Anticancer Activity in Men With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
    P1, N=232, Recruiting, Bayer | N=140 --> 232
    Enrollment change • Metastases
    |
    FOLH1 positive
    8d
    A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study (clinicaltrials.gov)
    P1, N=106, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    10d
    DKTK_PMO_1605: The Bispecific PSMAxCD3 Antibody CC-1 in Patients with Castration Resistant Prostate Carcinoma (clinicaltrials.gov)
    P1, N=86, Recruiting, University Hospital Tuebingen | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    CC-1
    12d
    A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive mCRPC (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Oct 2026 --> Aug 2025 | Trial primary completion date: Jan 2026 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    17d
    A Study of Stereotactic Body Radiotherapy and 177Lu-PSMA-617 for the Treatment of Prostate Cancer (clinicaltrials.gov)
    P1, N=27, Recruiting, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Recruiting
    Enrollment open • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    20d
    Intratumoral Distribution of [177Lu]Lu-PSMA-617 Over Time and in Relation to Diagnostic Tracers in Animal Models of Prostate Cancer. (PubMed, Cancer Biother Radiopharm)
    Regrowth of the tumor post-[177Lu]Lu-PSMA-617 administration creates Ki67+/PSMA+ areas that have no radioactivity uptake and need additional therapy fractions. The identical intratumoral distribution of [177Lu]Lu-PSMA-617 and PSMA-targeted PET-tracers indicate that these will reveal the areas inside the tumor targeted by RPT at least at 1 h p.i.
    Preclinical • Journal
    |
    FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    22d
    18F-Fluciclovine PET/CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer (clinicaltrials.gov)
    P4, N=15, Recruiting, VA Greater Los Angeles Healthcare System
    New P4 trial
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    23d
    Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT (clinicaltrials.gov)
    P1/2, N=200, Recruiting, Novartis Pharmaceuticals | Trial primary completion date: Aug 2026 --> Jun 2027
    Trial primary completion date
    |
    FOLH1 positive
    27d
    INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM) (clinicaltrials.gov)
    P1/2, N=52, Active, not recruiting, Inovio Pharmaceuticals | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    temozolomide • Libtayo (cemiplimab-rwlc) • INO-5401 • rocakinogene sifuplasmid (INO-9012)
    27d
    PSMA Radiotheranostics in Prostate Cancer: Principles, Practice, and Future Prospects. (PubMed, Radiographics)
    The U.S. Food and Drug Administration approval of 177Lu-PSMA-617 marked a substantial advancement in the treatment paradigm of metastatic castration-resistant prostate cancer, based on the VISION trial that showed improved overall survival and quality of life compared with those for standard care...This review underscores the role of PSMA radioligand therapy in the evolving landscape of prostate cancer treatment and its promise for improving patient outcomes.
    Review • Journal
    |
    FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    28d
    INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma (clinicaltrials.gov)
    P1/2, N=35, Active, not recruiting, Inovio Pharmaceuticals | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Tecentriq (atezolizumab) • INO-5401 • rocakinogene sifuplasmid (INO-9012)
    29d
    PSMA-617-100: Study of 225Ac-PSMA-617 in Men With PSMA-positive Prostate Cancer (clinicaltrials.gov)
    P1, N=99, Recruiting, Endocyte | N=60 --> 99
    Enrollment change
    |
    abiraterone acetate • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • AAA817
    29d
    A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer (clinicaltrials.gov)
    P1, N=24, Recruiting, Blue Earth Therapeutics Ltd | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    1m
    A PSMA-targeted Tri-specific Killer Engager enhances NK cell cytotoxicity against prostate cancer. (PubMed, Cancer Immunol Res)
    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.
    Journal • Trispecific
    |
    IL15 (Interleukin 15)
    |
    FOLH1 expression • FOLH1 positive
    1m
    PSMA Therapy and Immunotherapy in Kidney Cancer (clinicaltrials.gov)
    P1/2, N=37, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Jul 2031 --> Jan 2032 | Initiation date: Nov 2024 --> May 2025 | Trial primary completion date: Jul 2030 --> Jan 2031
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    Keytruda (pembrolizumab) • lutetium zadavotide guraxetan (PNT2002)
    1m
    Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Antitumor Activity of a Thorium-227 Labeled Antibody-chelator Conjugate Alone and in Combination With Darolutamide, in Patients With Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=63, Completed, Bayer | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Metastases
    |
    Nubeqa (darolutamide) • pelgifatamab corixetan (BAY 2315497)
    1m
    LuTectomy: Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy (clinicaltrials.gov)
    P1/2, N=20, Active, not recruiting, Peter MacCallum Cancer Centre, Australia | Trial completion date: Dec 2023 --> Aug 2025
    Trial completion date
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    1m
    ProstACT-GLOBAL: The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT GLOBAL) (clinicaltrials.gov)
    P3, N=430, Recruiting, Telix Pharmaceuticals (Innovations) Pty Limited | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • 177Lu-rosopatamab tetraxetan (TLX591)
    2ms
    CURLu177PSM0001: 177Lu-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P3, N=439, Active, not recruiting, Curium US LLC | Trial completion date: Jun 2029 --> Feb 2029
    Trial completion date • Metastases
    |
    Xtandi (enzalutamide) • abiraterone acetate • prednisone
    2ms
    Bullseye: Lutetium-177-PSMA-617 in Oligo-metastatic Hormone Sensitive Prostate Cancer (clinicaltrials.gov)
    P2, N=58, Active, not recruiting, Radboud University Medical Center | Recruiting --> Active, not recruiting | Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jan 2024 --> Mar 2025
    Enrollment closed • Trial completion date • Trial primary completion date • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    2ms
    PSMAddition: An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With SoC, Versus SoC Alone, in Adult Male Patients With mHSPC (clinicaltrials.gov)
    P3, N=1145, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    FOLH1 positive
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    2ms
    Phase I/II Trial of Pembrolizumab and Androgen-receptor Pathway Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P1/2, N=76, Recruiting, Weill Medical College of Cornell University | Suspended --> Recruiting
    Enrollment open • Metastases
    |
    Keytruda (pembrolizumab) • Xtandi (enzalutamide) • Ac-225 rosopatamab tetraxetan (CONV01-α)
    2ms
    INO 5401 Vaccination in BRCA1/2 Mutation Carriers (clinicaltrials.gov)
    P1, N=44, Recruiting, University of Pennsylvania | Phase classification: P1b --> P1
    Phase classification
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation • BRCA1 mutation
    |
    INO-5401 • rocakinogene sifuplasmid (INO-9012)
    2ms
    Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial (clinicaltrials.gov)
    P2, N=474, Not yet recruiting, Alliance for Clinical Trials in Oncology
    New P2 trial
    |
    carboplatin • Xtandi (enzalutamide) • abiraterone acetate • cabazitaxel • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Ezharmia (valemetostat)
    3ms
    177Lu-PSMA (177Lu-PNT2002) in PSMA-Positive Adenoid Cystic Carcinoma (clinicaltrials.gov)
    P2, N=10, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Initiation date: Sep 2024 --> Dec 2024
    Trial initiation date
    |
    lutetium zadavotide guraxetan (PNT2002)
    3ms
    (SEEtoTREAT): SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization (clinicaltrials.gov)
    P=N/A, N=80, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Initiation date: Sep 2024 --> Dec 2024
    Trial initiation date
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Lutathera (lutetium Lu 177 dotatate) • Xofigo (radium Ra-223 dichloride)
    3ms
    177-Lutetium-PSMA Before Stereotactic Body Radiotherapy for the Treatment of Oligorecurrent Prostate Cancer, The LUNAR Study (clinicaltrials.gov)
    P2, N=93, Active, not recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Sep 2025 --> Sep 2033 | Trial primary completion date: Sep 2024 --> Sep 2032
    Trial completion date • Trial primary completion date
    |
    lutetium zadavotide guraxetan (PNT2002)
    3ms
    Re-treatment 225Ac-J591 for mCRPC (clinicaltrials.gov)
    P1, N=6, Active, not recruiting, Weill Medical College of Cornell University | Recruiting --> Active, not recruiting | N=18 --> 6
    Enrollment closed • Enrollment change
    |
    Ac-225 rosopatamab tetraxetan (CONV01-α)
    3ms
    PROLUT: Comparison of Changes in Tumor Burden in 68Ga-PSMA-11 PET/CT and 177Lu-PSMA SPECT/CT in Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov)
    P=N/A, N=80, Not yet recruiting, Central Hospital, Nancy, France | Initiation date: Sep 2024 --> Jan 2025
    Trial initiation date • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    3ms
    Study With [225Ac]Ac-FL-020 in mCRPC Participants (clinicaltrials.gov)
    P1, N=35, Recruiting, Full-Life Technologies GmbH | Not yet recruiting --> Recruiting | Initiation date: Jul 2024 --> Oct 2024
    Enrollment open • Trial initiation date
    |
    225Ac-FL-020
    3ms
    Study of JANX007 in Subjects with Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01) (clinicaltrials.gov)
    P1, N=105, Recruiting, Janux Therapeutics | Trial completion date: Mar 2025 --> Dec 2026 | Trial primary completion date: Aug 2024 --> Jul 2025
    Trial completion date • Trial primary completion date • Metastases
    3ms
    Intensification Approaches and Treatment Sequencing in Metastatic Castration-resistant Prostate Cancer: A Systematic Review. (PubMed, Eur Urol)
    Recent approvals and ongoing investigations of single agents and intensification approaches will keep transforming the mCRPC treatment landscape. Improvement of patient profiling applying recognized genomic, molecular, and clinical predictive and prognostic indicators is fundamental to optimize sequential use of available therapies.
    Review • Journal • BRCA Biomarker • Metastases
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PTEN (Phosphatase and tensin homolog) • AKT1 (V-akt murine thymoma viral oncogene homolog 1)
    |
    BRCA2 mutation
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • ipatasertib (RG7440) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    3ms
    Initial Experience with [177Lu]Lu-PSMA-617 After Regulatory Approval for Metastatic Castration-Resistant Prostate Cancer: Efficacy, Safety, and Outcome Prediction. (PubMed, J Nucl Med)
    Artificial-intelligence-based analysis of baseline PSMA PET/CT images may improve patient selection. Validation of these findings on larger cohorts is warranted.
    Journal • Metastases
    |
    HRD (Homologous Recombination Deficiency)
    |
    FOLH1 positive
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    3ms
    A Study of Stereotactic Body Radiotherapy and 177Lu-PSMA-617 for the Treatment of Prostate Cancer (clinicaltrials.gov)
    P1, N=6, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Oct 2024 --> Oct 2025 | Trial primary completion date: Oct 2024 --> Oct 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    3ms
    PSMAddition: An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With SoC, Versus SoC Alone, in Adult Male Patients With mHSPC (clinicaltrials.gov)
    P3, N=1126, Recruiting, Novartis Pharmaceuticals | Active, not recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    FOLH1 positive
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    3ms
    Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer in Japan (clinicaltrials.gov)
    P2, N=80, Recruiting, Novartis Pharmaceuticals | Trial completion date: Nov 2028 --> Apr 2026
    Trial completion date • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    3ms
    ACCEL: [Ac-225]-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=142, Recruiting, POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company | N=48 --> 142
    Enrollment change • Metastases
    4ms
    PSMA Therapy and Immunotherapy in Kidney Cancer (clinicaltrials.gov)
    P1/2, N=37, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Initiation date: Jul 2024 --> Nov 2024
    Trial initiation date • Metastases
    |
    Keytruda (pembrolizumab) • lutetium zadavotide guraxetan (PNT2002)
    4ms
    Detection of tumour heterogeneity in patients with advanced, metastatic castration-resistant prostate cancer on [68Ga]Ga-/[18F]F-PSMA-11/-1007, [68Ga]Ga-FAPI-46 and 2-[18F]FDG PET/CT: a pilot study. (PubMed, Eur J Nucl Med Mol Imaging)
    Through whole-body imaging, we identify considerable inter- and intra-patient heterogeneity of mCRPC and potential imaging phenotypes. Regarding uptake and tumour detection, [68Ga]Ga-/[18F]F-PSMA-11/-1007 was superior to [68Ga]Ga-FAPI-46 and 2-[18F]FDG, while the latter two were comparable. Patients who underwent [177Lu]Lu-PSMA-617 RLT based on clinical-decision making had a longer overall survival and could be assigned to the PSMA-dominant phenotype.
    Journal • FDG PET • Metastases
    |
    FOLH1 (Folate hydrolase 1)
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    4ms
    CCTG PR21: 177 LuPSMA-617 vs Docetaxel in Metastatic Castration Resistant and PSMA-Positive Prostate Cancer (clinicaltrials.gov)
    P2, N=200, Active, not recruiting, Canadian Cancer Trials Group | Trial primary completion date: Jul 2024 --> Dec 2024
    Trial primary completion date
    |
    docetaxel • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)