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Locametz 25 micrograms kit for radiopharmaceutical preparation

DRUG15 trials

Sponsors

Unicancer, Novartis Pharma AG, Karolinska University Hospital, Universitaetsklinikum Essen AöR, Hospices Civils De Lyon

Conditions

Biochemical recurrence after prostate cancer surgeryMetastatic Castration-Resistant 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)PSMA PET scan positive Castration-Resistant Prostate Cancer (CRPC)PSMA-positive metastatic castration-resistant prostate cancerPSMA-positive metastatic hormone sensitive prostate cancer (mHSPC) and metastatic Castration-resistant Prostate Cancer (mCRPC) with or without prior 177Lu-PSMA radioligand therapy.

Phase 1

Phase 2

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
Diagnostic Performance of Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography/Computed Tomography (PET/CT) Imaging for Pre-operative Lymph Node Assessment in Intermediate and High-risk Nonmetastasic Prostate Cancer
CompletedCTIS2024-516319-25-00
Centre Hospitalier Regional Et Universitaire De BrestProstate Cancer
End: 2025-12-15Target: 159Updated: 2025-04-30
[177Lu]Lu-PSMAI&T radioligand therapy (PSMA-RLT) for patients with prostate cancer and biochemical but not radio-morphological local recurrence after primary therapy with curative intent: A Prospective Phase II Pilot Study
Not yet recruitingCTIS2024-519348-34-00
Medical University Of Viennaprostate carcinoma
Target: 26Updated: 2025-09-19
Neoadjuvant [177Lu]Lu-PSMAI&T radioligand therapy (PSMA-RLT) for patients with oligometastatic prostate cancer diagnosed using [68Ga]Ga-PSMA-11 PET imaging followed by radical prostatectomy: A Prospective Phase II Pilot Study
Not yet recruitingCTIS2024-519377-18-00
Medical University Of ViennaProstate Carcinoma
Target: 10Updated: 2025-11-17
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

Phase 3

A randomized trial comparing conventional "salvage" radiotherapy and individualized PSMA-PET/CT targeted treatment in patients with biochemical recurrence after prostate cancer surgery
RecruitingCTIS2023-504917-54-00
Karolinska University HospitalBiochemical recurrence after prostate cancer surgery
Start: 2018-10-30Target: 450Updated: 2024-10-09
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
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
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
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
Multi-institutional Evaluation of the Cost-effectiveness of PSMA-PET/CT for the Detection of Pelvic Lymph Node Invasion in Newly Diagnosed Prostate Cancer Patients (PSMA-SELECT).
Active, not recruitingCTIS2024-518171-59-00
Canisius Wilhelmina ZiekenhuisProstate Cancer
Start: 2025-01-23Target: 742Updated: 2025-07-31
PSMA PET For intermediate- or high-risk prostate cancer prior to RadioTherapY: A prospective interventional randomized clinical trial (P4RTY)
Not yet recruitingCTIS2023-506032-33-00
Universitaetsklinikum Essen AöRProstate cancer
Target: 352Updated: 2025-07-04