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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:
21h
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
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
2d
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)
2d
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
|
Zolinza (vorinostat) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • lutetium zadavotide guraxetan (PNT2002)
2d
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)
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FOLH1 positive
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Lynparza (olaparib) • abiraterone acetate • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
7d
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)
11d
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)
15d
Enrollment closed • Enrollment change
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Xtandi (enzalutamide) • abiraterone acetate • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
15d
Current and future perspectives on radioligand therapy in advanced prostate cancer. (PubMed, Ther Adv Med Oncol)
Nonetheless, challenges remain around long-term hematologic and renal safety, radionuclide supply, protocol standardization, and global accessibility. Ongoing and future multicenter trials, collaborative consortia, and innovations in theranostics will be critical to defining optimal patient selection, sequencing with existing therapies, and embedding RLT as a key pillar in the management of advanced PCa.
Review • Journal
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STEAP1 (STEAP Family Member 1) • KLK2 (Kallikrein-related peptidase 2)
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
30d
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: Sep 2028 --> Feb 2028
Trial primary completion date
|
docetaxel • Xtandi (enzalutamide) • abiraterone acetate • cabazitaxel • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • 225Ac-vipivotide tetraxetan (AAA817)
1m
177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
P1, N=30, Not yet recruiting, University of California, San Francisco | Initiation date: Oct 2025 --> Jan 2026
Trial initiation date
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
1m
New trial • Real-world evidence
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
1m
AcTFirst: Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC (clinicaltrials.gov)
P3, N=940, Recruiting, Novartis Pharmaceuticals | N=605 --> 940 | Trial primary completion date: Feb 2028 --> Sep 2028
Enrollment change • Trial primary completion date
|
docetaxel • Xtandi (enzalutamide) • abiraterone acetate • cabazitaxel • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • 225Ac-vipivotide tetraxetan (AAA817)