^
    7d
    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)
    7d
    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)
    9d
    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 capsule) • abiraterone acetate • 177Lu-rosopatamab tetraxetan (TLX591)
    15d
    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 capsule) • abiraterone acetate • prednisone
    16d
    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)
    23d
    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)
    30d
    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 capsule) • Ac-225 rosopatamab tetraxetan (CONV01-α)
    1m
    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)
    1m
    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 capsule) • abiraterone acetate • cabazitaxel • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Ezharmia (valemetostat)
    1m
    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)
    1m
    (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)
    1m
    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)
    2ms
    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)
    2ms
    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)
    2ms
    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
    2ms
    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
    2ms
    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 capsule) • abiraterone acetate • ipatasertib (RG7440) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    2ms
    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)
    2ms
    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)
    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=1126, Recruiting, Novartis Pharmaceuticals | Active, not recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    FOLH1 positive
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    2ms
    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)
    2ms
    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
    2ms
    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)
    2ms
    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)
    3ms
    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)
    3ms
    A Study of CBP-1018 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=170, Recruiting, Coherent Biopharma (Suzhou) Co., Ltd. | Trial primary completion date: Dec 2023 --> Oct 2024
    Trial primary completion date • Metastases
    |
    FOLR1 ( Folate receptor alpha )
    |
    CBP-1018
    3ms
    Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=15, Recruiting, University of Washington | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Zolinza (vorinostat) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    3ms
    TNB585.001: A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma (clinicaltrials.gov)
    P1, N=42, Completed, Amgen | Active, not recruiting --> Completed | Trial completion date: Sep 2024 --> Jun 2024 | Trial primary completion date: Sep 2024 --> Jun 2024
    Trial completion • Trial completion date • Trial primary completion date • Metastases
    3ms
    Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial (clinicaltrials.gov)
    P2, N=40, Recruiting, Jonsson Comprehensive Cancer Center | Initiation date: Dec 2024 --> Aug 2024 | Not yet recruiting --> Recruiting
    Enrollment open • Trial initiation date • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    3ms
    Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT) (clinicaltrials.gov)
    P2, N=90, Recruiting, Jonsson Comprehensive Cancer Center | Not yet recruiting --> Recruiting | Initiation date: Dec 2024 --> Aug 2024
    Enrollment open • Trial initiation date • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    3ms
    NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. (clinicaltrials.gov)
    P1, N=36, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Lutathera (lutetium Lu 177 dotatate) • AAA603
    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: Apr 2026 --> Nov 2028
    Trial completion date • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    4ms
    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, Not yet recruiting, Novartis Pharmaceuticals
    New P1 trial • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    4ms
    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, Suspended, Weill Medical College of Cornell University | Recruiting --> Suspended | Trial primary completion date: Jun 2025 --> Jun 2026
    Trial suspension • Trial primary completion date • Metastases
    |
    Keytruda (pembrolizumab) • Xtandi (enzalutamide capsule) • Ac-225 rosopatamab tetraxetan (CONV01-α)
    4ms
    Fractionated and Multiple Dose 225Ac-J591 for Progressive mCRPC (clinicaltrials.gov)
    P1/2, N=105, Suspended, Weill Medical College of Cornell University | Recruiting --> Suspended
    Trial suspension • Metastases
    |
    Ac-225 rosopatamab tetraxetan (CONV01-α)
    4ms
    Phase I/II 225Ac-J591 Plus 177Lu-PSMA-I&T for Progressive Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P1/2, N=48, Suspended, Weill Medical College of Cornell University | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial primary completion date • Metastases
    |
    lutetium zadavotide guraxetan (PNT2002) • Ac-225 rosopatamab tetraxetan (CONV01-α)
    4ms
    Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing Disease (clinicaltrials.gov)
    P2, N=51, Not yet recruiting, University of Washington
    New P2 trial • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    4ms
    LC-MS/MS method for dual-ligand peptide-drug CBP-1018 and its deconjugated payload MMAE including sample stabilization strategy for its MC-Val-Cit-PABC linker. (PubMed, Talanta)
    The results showed that CBP-1018 was eliminated immediately after injection and MMAE reached the maximum exposure at approximately 2 h after infusion. The maximum concentration of MMAE did not exceed 20.0 ng/mL, suggesting that the off-target toxicity of CBP-1018 injection was controllable.
    Journal
    |
    CTSS (Cathepsin S)
    |
    CBP-1018
    4ms
    The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT-GLOBAL) (clinicaltrials.gov)
    P3, N=430, Not yet recruiting, Telix Pharmaceuticals (Innovations) Pty Ltd
    New P3 trial • Combination therapy • Metastases
    |
    docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • 177Lu-rosopatamab tetraxetan (TLX591)
    4ms
    A Dosimetry Study of Lutetium (177Lu) rhPSMA 10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Metastatic Prostate Cancer (clinicaltrials.gov)
    P1, N=24, Not yet recruiting, Blue Earth Therapeutics Ltd
    New P1 trial • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    4ms
    Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Jonsson Comprehensive Cancer Center | Initiation date: Jun 2024 --> Dec 2024
    Trial initiation date • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    4ms
    The Safety and Dosimetry Study of 177Lu-LNC1003 Injection (clinicaltrials.gov)
    P1, N=12, Not yet recruiting, Yantai LNC Biotechnology Singapore PTE. LTD. | Initiation date: May 2024 --> May 2025
    Trial initiation date • Metastases
    |
    177Lu-LNC1003