^
    1d
    177Lu-PSMA-617 in Metastatic Castration Resistant Prostate Cancer (mCRPC) With Bone Marrow Involvement and Cytopenia (clinicaltrials.gov)
    P2, N=0, Withdrawn, M.D. Anderson Cancer Center | N=40 --> 0 | Trial completion date: Jun 2029 --> May 2026 | Suspended --> Withdrawn | Trial primary completion date: Jun 2027 --> May 2026
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date
    |
    FOLH1 positive
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    1d
    Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer in Japan (clinicaltrials.gov)
    P2, N=94, Completed, Novartis Pharmaceuticals | Active, not recruiting --> Completed
    Trial completion
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    2d
    Tri-specific Humabody CB307 Targeting CD137, Prostate-specific Membrane Antigen, and Human Serum Albumin Whole-body Biodistribution Measured with 89Zr-CB307 PET. (PubMed, Mol Cancer Ther)
    Tumor biopsies confirmed radioactivity. 89Zr-CB307 selectively accumulated in PSMA-positive tumor lesions without specific uptake in PSMA-positive-normal or lymphoid tissues in patients with mCRPC.
    Journal • IO biomarker
    |
    FOLH1 (Folate hydrolase 1) • TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    FOLH1 expression • FOLH1 positive
    |
    CB307
    2d
    Theranostics in Nuclear Medicine: Historical, Regulatory, and Evidence Context for the Practicing Nuclear Medicine Physician. (PubMed, PET Clin)
    Theranostic radiopharmaceutical therapy has moved from niche practice to mainstream oncology, anchored by approvals of lutetium Lu 177 dotatate for somatostatin receptor-positive neuroendocrine tumors and lutetium Lu 177 vipivotide tetraxetan for PSMA-positive prostate cancer. Yet the field's future depends on rigorous clinical trial design, realistic operational planning, and workforce readiness. This review summarizes how theranostics evolved, outlines current regulatory and trial-design yardsticks (including dose optimization and expectations for assessment of late-toxicity), and provides a practical framework for nuclear medicine physicians to assess protocols and prepare their practices for expanding indications and combinations.
    Review • Journal
    |
    SSTR (Somatostatin Receptor)
    |
    SSTR positive • FOLH1 positive
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Lutathera (lutetium Lu 177 dotatate)
    3d
    Precision Oncology with 177Lu-PSMA-617 Radionuclide Therapy in Elderly Patients with Metastatic Castration-Resistant Prostate Cancer. (PubMed, Cancer Biother Radiopharm)
    Elderly mCRPC patients undergoing 177Lu-PSMA-617 radioligand therapy achieve meaningful PSA50 response rates, with baseline hemoglobin, prior docetaxel exposure, tumor burden, PSMA expression level, and ALP being independent predictors of response. Treatment response is closely associated with improved quality of life and mental health outcomes, with response rates improving with additional therapy cycles. These findings provide evidence-based guidance for precision patient selection, treatment monitoring, and individualized optimization strategies for 177Lu-PSMA-617 therapy.
    Journal
    |
    FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression
    |
    docetaxel • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    4d
    FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
    P2, N=85, Active, not recruiting, Fusion Pharmaceuticals Inc. | Trial completion date: Aug 2030 --> May 2027 | Trial primary completion date: Jan 2030 --> May 2027
    Trial completion date • Trial primary completion date
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation • FOLH1 positive
    |
    Lynparza (olaparib) • FPI-2265
    5d
    A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With REGN5678 for Adult Participants With Advanced Prostate Cancer (clinicaltrials.gov)
    P1/2, N=228, Recruiting, Regeneron Pharmaceuticals | N=370 --> 228 | Trial completion date: Jan 2027 --> Mar 2030 | Trial primary completion date: Jan 2027 --> Mar 2030
    Enrollment change • Trial completion date • Trial primary completion date
    |
    nezastomig (REGN5678)
    5d
    A Study of TRC003 in the Treatment of Patients With Progressive PSMA-positive mCRPC (clinicaltrials.gov)
    P1/2, N=90, Not yet recruiting, C Ray Therapeutics
    New P1/2 trial
    |
    FOLH1 positive
    5d
    A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer (clinicaltrials.gov)
    P1, N=355, Recruiting, Janssen Research & Development, LLC | N=250 --> 355
    Enrollment change
    |
    apalutamide • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • JNJ-6143 • pasritamig (JNJ-8343)
    8d
    Prospective Clinical Trial of 177Lu-P17-088 in the Treatment of Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=20, Recruiting, First Affiliated Hospital of Fujian Medical University
    New P2 trial • First-in-human
    |
    177Lu-P17-088
    8d
    PSMAndARPI: An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC (clinicaltrials.gov)
    P2, N=7, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Apr 2029 --> Oct 2026 | Trial primary completion date: Apr 2029 --> Oct 2026
    Trial completion date • Trial primary completion date
    |
    Xtandi (enzalutamide) • abiraterone acetate • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    10d
    PSMA-617-100: Study of 225Ac-PSMA-617 in Men With PSMA-positive Prostate Cancer (clinicaltrials.gov)
    P1, N=101, Active, not recruiting, Endocyte | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    FOLH1 positive
    |
    abiraterone acetate • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • 225Ac-vipivotide tetraxetan (AAA817)