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DRUG:

Pluvicto (lutetium Lu 177 vipivotide tetraxetan)

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Other names: 177 Lu PSMA-617, Lu177-PSMA-617, Lu177 RLT, 177LU-PSMA-617, PSMA-617, 177lutetium-PSMA-617, AAA617, AAA-617, AAA 617
Company:
Novartis, Otsuka
Drug class:
Beta radiation emitter, PSMA inhibitor
Related drugs:
6d
AcTFirst: Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC (clinicaltrials.gov)
P3, N=940, Recruiting, Novartis Pharmaceuticals | Trial primary completion date: Feb 2028 --> Sep 2028
Trial primary completion date
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HRD (Homologous Recombination Deficiency)
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docetaxel • Xtandi (enzalutamide) • abiraterone acetate • cabazitaxel • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • 225Ac-vipivotide tetraxetan (AAA817)
6d
Clonal hematopoiesis after 177Lu-PSMA-617 radioligand therapy in prostate cancer. (PubMed, Clin Cancer Res)
177Lu-PSMA-617 strongly promotes CH, supporting integration of longitudinal monitoring for long-term hematologic sequelae as radioligand therapy is implemented earlier in prostate cancer care.
Journal
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PPM1D (Protein Phosphatase Mg2+/Mn2+ Dependent 1D)
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docetaxel • cabazitaxel • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
7d
PSMACare: A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC (clinicaltrials.gov)
P2, N=46, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | N=80 --> 46
Enrollment closed • Enrollment change
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FOLH1 positive
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Xtandi (enzalutamide) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
10d
Enrollment closed
|
TP53 (Tumor protein P53) • PTEN (Phosphatase and tensin homolog) • RB1 (RB Transcriptional Corepressor 1) • SSTR2 (Somatostatin Receptor 2) • SYP (Synaptophysin) • CHGA (Chromogranin A)
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Lutathera (lutetium Lu 177 dotatate) • AAA603
12d
A real-world study of 177Lu-PSMA-617 in the treatment of mCRPC (ChiCTR2500114390)
P=N/A, N=20, Not yet recruiting, Shanghai General Hospital; Shanghai General Hospital
New trial
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
12d
An Exploratory Study of 177Lu-PSMA-617 in Combination with 177Lu-TBM-001 for the Treatment (Cocktail Therapy) of Metastatic Chemoresistant Prostate Cancer (mCRPC) (ChiCTR2500113787)
P=N/A, N=30, Recruiting, West Southwest Medical University Affiliated Hospital; West Southwest Medical University Affiliated Hospital
New trial
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
14d
Pilot of 18F-DCFPyL-PSMA PET in mCRPC Patients Receiving 117Lu-Vipivotide Tetraxetan (clinicaltrials.gov)
P4, N=30, Recruiting, Brigham and Women's Hospital | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
Trial completion date • Trial primary completion date
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
15d
177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
P1, N=30, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting | Trial completion date: Jun 2027 --> Jul 2028 | Initiation date: Dec 2025 --> Mar 2026 | Trial primary completion date: Jun 2027 --> Jul 2028
Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date
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PSAP (Prostatic Acid Phosphatase)
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Provenge (sipuleucel-T)
15d
VALOR: Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
P2, N=15, Recruiting, Fred Hutchinson Cancer Center | Trial primary completion date: Jul 2026 --> Dec 2026
Trial primary completion date
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Zolinza (vorinostat) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • lutetium zadavotide guraxetan (PNT2002)
15d
Emerging Therapeutic Strategies in Prostate Cancer: Targeted Approaches Using PARP Inhibition, PSMA-Directed Therapy, and Androgen Receptor Blockade with Olaparib, Lutetium (177Lu)Vipivotide Tetraxetan, and Abiraterone. (PubMed, J Clin Med)
We conclude that the optimal use of PARP inhibitors, PSMA-targeted RLT, and ARPIs requires a personalized strategy guided by molecular profiling, functional imaging, prior treatment exposure, and safety considerations. This clinically focused overview aims to support evidence-based decision-making in an increasingly complex treatment landscape.
Review • Journal • BRCA Biomarker • PARP Biomarker
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • AR (Androgen receptor) • HRD (Homologous Recombination Deficiency)
|
FOLH1 positive
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Lynparza (olaparib) • abiraterone acetate • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
20d
VALOR: Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
P2, N=15, Recruiting, Fred Hutchinson Cancer Center | Trial primary completion date: Dec 2025 --> Jul 2026
Trial primary completion date
|
Zolinza (vorinostat) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • lutetium zadavotide guraxetan (PNT2002)
24d
Treatment Strategies in Metastatic Castration-Resistant Prostate Cancer: A Narrative Review of Considerations in the Post-ARTA, Post-Docetaxel Setting. (PubMed, Oncol Ther)
Available therapeutic options include radioligand therapy (e.g. lutetium-177-PSMA-617), cabazitaxel, PARP inhibitors (particularly for patients with DNA repair gene alterations), second-line ARTAs, further chemotherapy and immunotherapeutic approaches. Finally, the review provides an overview of promising emerging therapies poised to expand the treatment landscape for mCRPC. These include bispecific T cell engagers, androgen receptor degraders, and antibody-drug conjugates, which are currently under investigation in clinical trials and may soon offer new avenues for treatment beyond traditional mechanisms.
Review • Journal • BRCA Biomarker • PARP Biomarker • IO biomarker
|
AR (Androgen receptor) • BRCA (Breast cancer early onset) • FOLH1 (Folate hydrolase 1)
|
FOLH1 expression
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docetaxel • cabazitaxel • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)