Skip to content

Pluvicto 1 000 MBq/mL solution for injection/infusion

DRUG19 trials

Sponsors

Universitaetsklinikum Essen AöR, Unicancer, Novartis Pharma AG, Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy, Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy, Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

Conditions

Adenoid cystic carcinomaClear Cell Renal Cell Carcinoma (ccRCC)Metastatic Castration-Resistant Prostate CancerMetastatic castration resistant prostate cancer (mCRPC)Metastatic hormone sensitive prostate cancerMetastatic prostate cancerNovo metastatic hormone-sensitive prostate cancer (mHSPC) patients having a serum PSA level of ≥ 0.2 ng/mL at 6 to 8 months after systemic treatment initiation for mHSPC (i.e. poor responders) in the absence of evidence of cancer progression (including a rising PSA level)Oligometastatic prostate cancer (OMPC)

Phase 1

A Phase I/II Study of Neoadjuvant, Intra-arterial Administration of [177Lu]Lu-PSMA-617 in Subjects with High-risk, Localised or Locally Advanced Prostate Cancer who are Candidates for Radical Prostatectomy (LUPUS)
RecruitingCTIS2022-500838-28-00
Universitaetsklinikum Essen AöRhigh-risk localized or locally advanced prostate cancer
Start: 2024-09-10Target: 22Updated: 2024-08-29
A phase I study of neoadjuvant treatment with 177-Lutetium-PSMA-617 with Ipilimumab in subjects with very high-risk prostate cancer who are candidates for radical prostatectomy (NEPI Trial)
SuspendedCTIS2024-514386-19-00
Universitaetsklinikum Essen AöRPatients with very high-risk prostate cancer (as defined by a total Gleason-Score ≥4+4 [ISUP-GG 4+5] and clinical stage cT3 (digital rectal examinations or imaging based) plus clinical nodal status cN+ or Serum-PSA level > 20 ng/ml who are candidates for radical prostatectomy with pelvic lymph node dissection.
Start: 2025-08-25Target: 12Updated: 2025-07-22
A Phase I, open-label, multi-center 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
RecruitingCTIS2024-512338-13-00
Novartis Pharma AGMetastatic Castration-Resistant Prostate Cancer
Start: 2024-11-11Target: 63Updated: 2025-10-20
A randomised, multi-centre, intra-patient imaging and dosimetry crossover study of lutetium (177Lu) rhPSMA-10.1 and lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) in patients with non-curative metastatic prostate cancer
CompletedCTIS2024-515264-31-00
Blue Earth Therapeutics LimitedPSMA-positive non-curative metastatic castration-resistant prostate cancer
Start: 2025-04-15End: 2025-08-14Target: 18Updated: 2025-06-13
A phase Ib/II open-label, multi-center study of the DNA protein kinase inhibitor AMO959 with lutetium (177Lu) vipivotide tetraxetan (AAA617) in combination with an androgen receptor pathway inhibitor (ARPI) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC)
Not yet recruitingCTIS2025-521859-23-00
Novartis Pharma AGPSMA-positive mCRPC with prior exposure to at least one prior ARPI
Target: 61Updated: 2026-03-06

Phase 2

The evaluation of the effectiveness, safety and tolerability of treatment, using a specialized prostate-specific membrane antigen (PSMA) labeled with Lutetium177, in patients with recurrent and/or metastatic adenoid cystic carcinoma originating from the salivary glands - an open, non-commercial clinical trial
CompletedCTIS2023-504699-73-00
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy, Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut BadawczyAdenoid cystic carcinoma
End: 2025-04-03Target: 32Updated: 2024-01-12
177Lu-PSMA as a systemic adjuvant treatment in patients with high and very high risk prostate cancer after radical treatment with locoregional teleradiotherapy and hormone therapy.
RecruitingCTIS2023-504912-13-00
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut BadawczyProstate Cancer
Start: 2025-01-09Target: 200Updated: 2025-01-08
An Open-label Dosimetry, Biodistribution, Tolerability and Safety Study of lutetium (177Lu) vipivotide tetraxetan in Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Moderately and Severely Impaired and with normal Renal Function
RecruitingCTIS2023-503925-20-00
Novartis Pharma AGProgressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) with moderate and severe renal impairment and with normal renal function.
Start: 2024-04-04Target: 15Updated: 2025-11-12
An international prospective open-label, multi-center, randomized, non-comparative phase II study of lutetium [177Lu] vipivotide tetraxetan (AAA617) alone and lutetium [177Lu] vipivotide tetraxetan (AAA617) in combination with androgen receptor pathway inhibitors in patients with PSMA PET scan positive castration-resistant prostate cancer (PSMACare)
Active, not recruitingCTIS2022-503040-41-00
Novartis Pharma AGPSMA PET scan positive Castration-Resistant Prostate Cancer (CRPC)
Start: 2024-02-09Target: 45Updated: 2025-12-16
Lutetium-177-PSMA in Oligo-metastatic Hormone Sensitive Prostate Cancer.
CompletedCTIS2023-509881-39-00
Stichting Radboud University Medical Centerprostate cancer
Start: 2020-07-27End: 2026-01-19Target: 58Updated: 2024-07-31
ReaLuP : an open label, single arm phase IIb study of re-treatment with [177Lu]Lu-PSMA in men with metastatic castration resistance prostate cancer
RecruitingCTIS2024-512043-22-00
Hospices Civils De LyonMetastatic prostate cancer
Start: 2025-04-11Target: 58Updated: 2025-12-15
EORTC-2361-GUCG: Phase II trial evaluating the efficacy of 177Lutetium-PSMA treatment in patients with metastatic clear cell Renal Carcinoma Cell with progressive disease on first-line or second-line systemic treatment (RENALUT)
Not yet recruitingCTIS2024-517899-38-00
Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European OrganiClear Cell Renal Cell Carcinoma (ccRCC)
Target: 58Updated: 2025-12-18
A Phase II, randomized, open-label, multi-center study of JSB462 in combination with lutetium (177Lu) vipivotide tetraxetan in adult male patients with PSMA-positive metastatic castration resistant prostate cancer (mCRPC)
RecruitingCTIS2024-520155-24-00
Novartis Pharma AGMetastatic castration resistant prostate cancer (mCRPC)
Start: 2025-10-16Target: 46Updated: 2026-01-26

Phase 3

An International, Prospective, Open-label, Multi-center, Randomized Phase III Study comparing lutetium (177Lu) vipivotide tetraxetan (AAA617) versus Observation to delay castration or disease recurrence in adult male patients with prostate-specific membrane antigen (PSMA) positive Oligometastatic Prostate Cancer (OMPC)
RecruitingCTIS2022-502956-29-00
Novartis Pharma AGOligometastatic prostate cancer (OMPC)
Start: 2024-07-01Target: 215Updated: 2026-01-19
PSMAfore: A phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of androgen receptor-directed therapy in the Treatment of Taxane Naïve Men with Progressive Metastatic Castrate Resistant Prostate Cancer
Active, not recruitingCTIS2023-507772-50-00
Novartis Pharma AGPSMA-positive metastatic castration-resistant prostate cancer
Start: 2021-06-16Target: 334Updated: 2025-12-15
PSMAddition: An International Prospective Open-label, Randomized, Phase III Study comparing 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
Active, not recruitingCTIS2023-507970-42-00
Novartis Pharma AGPSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC)
Start: 2021-03-31Target: 445Updated: 2026-01-26
PEACE-6 Poor Responders: A randomized phase III trial evaluating the efficacy and safety of 177Lu-PSMA-617 in addition to Standard of Care (SoC) versus SoC alone in de novo metastatic hormone-sensitive prostate cancer (mHSPC) patients having a serum PSA level of ≥ 0.2 ng/mL at 6 to 8 months after systemic treatment initiation for mHSPC.
RecruitingCTIS2022-502408-57-00
UnicancerNovo metastatic hormone-sensitive prostate cancer (mHSPC) patients having a serum PSA level of ≥ 0.2 ng/mL at 6 to 8 months after systemic treatment initiation for mHSPC (i.e. poor responders) in the absence of evidence of cancer progression (including a rising PSA level)
Start: 2024-09-04Target: 300Updated: 2025-10-07
Studying Treatments in patients receiving androgen deprivation therapy (ADT) for Metastatic Prostate Cancer: Evaluation of Drug and radiation Efficacy: A 2nd multi-arm multi-stage randomised controlled trial (STAMPEDE2)
Not yet recruitingCTIS2025-522145-21-00
University College LondonMetastatic hormone sensitive prostate cancer
Target: 76Updated: 2026-02-25

Phase 4

Related Papers