Informations générales (source: ClinicalTrials.gov)
An Open Label, Single Arm Phase IIb Study of Re-treatment With [177Lu]Lu-PSMA in Men With Metastatic Castration Resistance Prostate Cancer
Interventional
Phase 2
Hospices Civils de Lyon (Voir sur ClinicalTrials)
avril 2025
avril 2030
02 février 2026
Prostate cancer is the third leading cause of cancer-related death in men in the United
States and Europe. The treatment of metastatic castration-resistant prostate cancer
(mCRPC) has evolved with the arrival of the radioligand [177Lu]Lu-PSMA-617, which
specifically targets PSMA-expressing cancer cells.
The randomized phase III VISION study showed that [177Lu]Lu-PSMA-617 significantly
improved progression-free survival and overall survival with an acceptable toxicity
profile.
The ReaLuP study will evaluate the efficacy of a re-treatment of [177Lu]Lu-PSMA-617 in
patients with progressive PSMA-positive mCRPC and who have been previously treated with
[177Lu]Lu-PSMA without evidence of progression during this first course of treatment.
Patients will be treated until disease progression, unacceptable toxicity or death, or
alternatively up to 9 months after the last dose of treatment.
At the end of this follow up period, patients will enter the " long term follow up ", at
least for 2 years after the end of the last active follow-up.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | D�sir�e DEANDREIS | 30/07/2026 15:20:33 | Contacter | ||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hôpital Louis Pradel, Hospices Civils de Lyon - 69500 - Bron 3029931 - France | Choaib LACHACHI, MD | Contact (sur clinicalTrials) | |||
| Médecine Nucléaire, Centre Hospitalier de Grenoble Alpes - 38043 - Grenoble 3014728 - France | Loïc DJAÏLEB, MD/PhD | Contact (sur clinicalTrials) | |||
| Médecine Nucléaire, CHU de Nantes Hôtel-Dieu - 44000 - Nantes 2990969 - France | Clément BAILLY, MD | Contact (sur clinicalTrials) | |||
| Médecine Nucléaire, Institut de Cancérologie de Strasbourg - 67200 - Strasbourg 2973783 - France | François SOMME, MD | Contact (sur clinicalTrials) | |||
| Oncologie Médicale, Centre Hospitalier Lyon Sud, HCL - 69310 - Pierre-Bénite 2987314 - France | Denis MAILLET, Prof; MD/PhD | Contact (sur clinicalTrials) | |||
| Oncologie Médicale, Centre Jean Perrin - 63011 - Clermont-Ferrand 3024635 - France | Hakim MAHAMMEDI, MD | Contact (sur clinicalTrials) | |||
| Oncologie Médicale, CHU Brest-Hôpital Morvan - 29200 - Brest 3030300 - France | Benjamin AUBERGER, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Nancy - 54511 - Vandœuvre-lès-Nancy 2970797 - France | Marine CLAUDIN, MD | Contact (sur clinicalTrials) | |||
| Institut de cancérologie du Gard - 30000 - Nîmes 2990363 - France | Nadine HOUEDE, MD | Contact (sur clinicalTrials) | |||
| Médecine Nucléaire, Centre Léon Berard - 69373 - Lyon 2996944 - France | Anne-Laure GIRAUDET, MD/PhD | Contact (sur clinicalTrials) | |||
| Médecine Nucléaire, Institut Bergonié - 33000 - Bordeaux 3031582 - France | Paul SCHWARTZ, MD | Contact (sur clinicalTrials) | |||
| Oncologie Médicale, Centre Antoine Lacassagne - 06189 - Nice 2990440 - France | Delphine BORCHIELLINI, MD | Contact (sur clinicalTrials) | |||
| Oncologie Médicale, Centre François Baclesse - 14076 - Caen 3029241 - France | Florence JOLY, MD | Contact (sur clinicalTrials) | |||
| Oncologie Médicale, Centre Henri Becqueret - 76038 - Rouen 2982652 - France | Laetitia AUGUSTO, MD | Contact (sur clinicalTrials) | |||
| Oncologie Médicale, CHU Saint Etienne - 42270 - Saint-Priest-en-Jarez 2977350 - France | Pierre-Benoit BONNEFOY, MD | Contact (sur clinicalTrials) | |||
Critères
Homme
- Males ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 assessed within 7
days of study treatment initiation
- Histologically or cytologically confirmed adenocarcinoma of prostate (Patients with
small cell carcinoma of the prostate may be included)
- Metastatic disease documented by at least one lesion on bone scan or
abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI)
scan assessed by investigator. Patients without bone metastasis must have measurable
lesions in extra-pelvic lymph nodes or in soft-tissues as defined by RECIST 1.1
criteria
- Confirmed progression mCRPC despite ongoing androgen deprivation with serum
testosterone < 50ng/dl (1.7nM) within 3 months prior to screening. Progression is
defined by the presence of at least one of the following criteria :
- PSA progression using local laboratory values as defined by a minimum of 2
consecutive rising PSA levels with an interval of ≥1 week between each
assessment where the PSA value at screening should be ≥1 ng/mL
- Radiographic disease progression in bone based on PCWG3 criteria defined as the
appearance of 2 or more new bone lesions on bone scan, with or without PSA
progression
- Radiographic disease progression in extra-pelvic lymph nodes based or
soft-tissues on RECIST1.1 criteria with or without PSA progression
- PSMA positive metastatic lesions on [68Ga]-PSMA-PET/CT without PSMA negative lesion
(The presence of PSMA-positive lesions is defined as [68Ga]-PSMA-11 uptake greater
than that of liver parenchyma in one or more metastatic lesions of any size in any
organ system. The presence of PSMA-negative lesions is defined as PSMA uptake equal
to or lower than that of liver parenchyma in any lymph node with a short axis of at
least 2.5 cm, in any metastatic solid-organ lesions with a short axis of at least
1.0 cm, or in any metastatic bone lesion with a soft-tissue component of at least
1.0 cm in the short axis. Patients with any PSMA negative metastatic lesion meeting
these criteria are ineligible).
- Participants must have been previously treated with at least 4 consecutive cycles of
[177Lu]Lu-PSMA with no evidence of progression during this first course of treatment
(including radiological, clinical but also PSA progression).
- Participants must have been previously treated with at least one ARSI - Androgen
Receptor Signaling Inhibitors - (including enzalutamide, apalutamide, abiraterone or
darolutamide) initiated for mCSPC, nmCRPC or mCRPC. (ARSI may be also administered
together with [177Lu]Lu-PSMA-617 provided that the patient has not received an
identical ARSI in the past and that this ARSI was initiated at least 15 days before
the first cycle of [177Lu]Lu-PSMA-617 and less than 2 months ago. The ARSI
administrated in association with LuPSMA should not be considered as a prior
therapy. A previous ARSI treatment is mandatory for patient eligibility)
- Patients must have been previously treated with at least one taxane based
chemotherapy (with docetaxel or cabazitaxel) (The number of previously administrated
lines of taxane-based therapy is not limited ; patients can have received a
taxane-based chemotherapy before or after the first sequence of [177Lu]Lu-PSMA)
- Patients must have been progressed at least 120 days after the last injection of the
first course of [177Lu]Lu-PSMA therapy. (Patients with a radiological or clinical
progressive disease during the first 120 days after the last cycle of the first
course of [177Lu]Lu-PSMA are not eligible. PSA progression is defined by a ≥ 25%
increase in PSA and an absolute increase of 2 ng/mL or more from the NADIR and
confirmed by a second consecutive value obtained 3 or more weeks later. Patients
treated with chemotherapy, ARSI or PARP inhibitors between the first 117LuPSMA
course and screening are also eligible).
- Be abstinent from heterosexual intercourse OR must agree to use contraception unless
confirmed to be azoospermic (vasectomized or secondary medical cause) until 98 days
(14 weeks) post-treatment.
- Adequate organ functions :
- Bone marrow reserve :
- ANC ≥ 1.5 X 109/L
- Platelets ≥ 100 X 109/L
- Hemoglobin ≥ 10 g/dL
- Hepatic :
- Total bilirubin ≤ 2 x ULN. For patients with known Gilbert's syndrome ≤ 3
x ULN.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3 x
ULN
- Renal :
- Clearance ≥40 ml/mn
- Patients must have signed informed consent prior to participating in any study
related procedures
- Willing and able to comply with the protocol, including follow-up visits and
examinations
- Patients have to be affiliated to the French social security system, or equivalent
Exclusion Criteria:
- History of a [177Lu]Lu-PSMA serious adverse event (SAE) or CTCAE Grade 3 or 4 AE
during the initial course of [177Lu]Lu-PSMA that led to the discontinuation of
treatment
- More than one course of [177Lu]Lu-PSMA therapy
- Less than 120 days from the last dose administrated in the initial course of
[177Lu]Lu-PSMA treatment and the radiological or clinical disease progression, or
the initiation of a subsequent therapy.
- Any history of treatment with radium-223 dichloride or other systemic radiotherapy
(including strontium-89, samarium-153, actinium-PSMA...)
- Transfusion of red blood cells within 30 days prior to the first injection of the
re-treatment of [177Lu]Lu-PSMA-617
- Current central nervous system (CNS) metastases
- Hypersensitivity to the active substance (Lutetium [177Lu] vipivotide tetraxetan or
Gallium [68Ga] gozetotide) or to any of the excipients
- Prior > hemibody external radiotherapy
- Imminent or established spinal cord compression based on clinical findings and / or
MRI that has not yet been treated
- Other malignancy treated within the last 3 years (except non-melanoma skin cancer or
low-grade superficial bladder cancer)
- Chronic conditions associated with non-malignant abnormal bone growth (e.g.,
confirmed Paget's disease of bone)
- Ongoing participation in any other clinical trial who may interfere with the present
study in the judgment of the investigator
- Concurrent serious (as determined by the Principal Investigator) medical conditions,
including, but not limited to, uncontrolled infection, known active hepatitis B or
C, or other significant co-morbid conditions that in the opinion of the investigator
would impair study participation or cooperation.
- Active clinically significant cardiac disease
- History of somatic or psychiatric disease/condition that may interfere with the
objectives and assessments of the study
- Patients under tutorship or guardianship