Locametz 25 micrograms kit for radiopharmaceutical preparation
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
SatisfACtion: A Phase I/II, open-label, multi-center study of [225Ac]Ac-PSMA-R2 in men with metastatic hormone sensitive prostate cancer (mHSPC) and in men with heavily pre-treated PSMA positive metastatic castration resistant prostate cancer (mCRPC) with or without prior 177Lu-labelled PSMA-targeted radioligand therapy
Active, not recruitingCTIS2023-507672-52-00
Start: 2023-11-07Target: 32Updated: 2025-11-13
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
Start: 2024-11-11Target: 63Updated: 2025-10-20
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
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
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
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
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
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
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
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
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
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
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
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
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
Target: 352Updated: 2025-07-04