Informations générales (source: ClinicalTrials.gov)
A Randomized Phase III Trial Evaluating the Efficacy and Safety of Standard of Care +/- 177Lu-PSMA617 in de Novo Metastatic Hormone-sensitive Prostate Cancer Patients Having a PSA≥0.2 ng/mL at 6-8 Months After Systemic Treatment Initiation
Interventional
Phase 3
UNICANCER (Voir sur ClinicalTrials)
septembre 2024
août 2039
05 avril 2025
PEACE-6 Poor Responders is an international, multicenter, open-label, controlled,
randomized, phase III trial to evaluate the efficacy and safety of 177Lu-PSMA-617 when
administered on top of the ongoing standard systemic treatment compared to standard
systemic treatment alone in patients with de novo metastatic hormone-sensitive prostate
cancer (mHSPC) who do not present with a satisfactory response characterized by a serum
prostatic specific antigen (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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Alice BERNARD TESSIER | 04/09/2026 14:00:06 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Olivier Hullard, 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 | |||||
| Centre Antoine Lacassagne - Nice - France | Delphine Borchiellini, MD | Contact (sur clinicalTrials) | |||
| Centre Eugène Marquis - Rennes - France | Laurence Crouzet, MD | Contact (sur clinicalTrials) | |||
| Centre Francois Baclesse - Caen - France | Florence Joly, MD | Contact (sur clinicalTrials) | |||
| Centre Georges-François Leclerc - Dijon - France | Clément Drouet, MD | Contact (sur clinicalTrials) | |||
| Centre Henri Becquerel - Rouen - France | David Tonnelet, MD | Contact (sur clinicalTrials) | |||
| Centre Léon Berard - Lyon - France | Aude Flechon, MD | Contact (sur clinicalTrials) | |||
| CHRU Brest - Brest - France | Friederike Schlurmann, MD | Contact (sur clinicalTrials) | |||
| CHRU Nancy - Nancy - France | Pierre Olivier, MD | Contact (sur clinicalTrials) | |||
| CHRU Tours - Tours - France | Mathilde Cancel, MD | Contact (sur clinicalTrials) | |||
| CHU Grenoble - Grenoble - France | Loic Djaileb, MD | Contact (sur clinicalTrials) | |||
| CHU Henri Mondor - Créteil - France | Caroline Saldana, MD | Contact (sur clinicalTrials) | |||
| CHU Rouen - Rouen - France | Laetitia Augusto, MD | Contact (sur clinicalTrials) | |||
| CHU Saint Etienne - Saint-Priest-en-Jarez - France | Pierre Cornillon, MD | Contact (sur clinicalTrials) | |||
| Gustave Roussy - Villejuif - France | Karim FIZAZI, MD | Contact (sur clinicalTrials) | |||
| Hôpital Saint Louis - Paris - France | Hélène Gauthier | Contact (sur clinicalTrials) | |||
| ICANS - Strasbourg - France | Philippe Barthelemy, MD | Contact (sur clinicalTrials) | |||
| Institut Bergonié - Bordeaux - France | Paul Schwartz, MD | Contact (sur clinicalTrials) | |||
| Institut Curie - Saint-Cloud - France | Capucine Richard, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Lorraine - Vandœuvre-lès-Nancy - France | Vincent MASSARD, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest - Angers - France | Elouen Boughalem, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest - Saint-Herblain - France | Emmanuelle Bompas, MD | Contact (sur clinicalTrials) | |||
| Institut Paoli-Calmettes - Marseille - France | Gwenaelle Gravis, MD | Contact (sur clinicalTrials) | |||
| IUCT Oncopole - Toulouse - France | Loic Mourey, MD | Contact (sur clinicalTrials) | |||
Critères
Homme
Inclusion Criteria:
All of the following criteria must be met ahead of randomization to satisfy trial
eligibility requirements:
1. Signed a written informed consent form prior to any trial specific procedures.
Note: In case of physical incapacitation, a trusted representative of their choice,
which is not the Investigator or sponsor, can sign on the behalf of the patients.
2. Aged ≥18 years old
3. Life expectancy > 6 months as per investigator estimate
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
5. Men with histologically or cytologically confirmed adenocarcinoma of the prostate
6. De novo metastatic disease defined by clinical or radiographic evidence of
metastases at diagnosis (i.e. before any treatment started). If not available, a
more recent imaging can be used
7. Measurable disease or bone lesions evaluable according to PCWG3 criteria. Patients
with doubtful bone metastases are not eligible
8. A pre-randomization 68Ga-PSMA-11 PET/CT scan performed within 4 weeks prior to
randomization in the trial.
FDG PET scan is not required for this protocol. All patients will be treated
independently from the results of pre-randomization PSMA PET scan: patients with
PSMA-positive or PSMA-negative disease according to PROMISE 2.0 criteria are
eligible.
9. Have 6 to 8 months of previous AND ongoing standard systemic treatment for prostate
cancer consisting in either:
- ADT with an androgen receptor signaling inhibitor (ARSI) (i.e., abiraterone
(plus prednisone), or apalutamide or enzalutamide) ± radiotherapy **
- ADT with docetaxel* plus an ARSI (i.e. abiraterone (plus prednisone), or
darolutamide,) ± radiotherapy**
Note:
*Docetaxel must have been stopped at least 4 weeks ahead of randomization.
** Previous radiotherapy to the primary tumor and/or to the metastases is accepted
as long as it was not PSMA-based and must has been completed at least 4 weeks ahead
of randomization.
10. Stable or declining PSA level but not a rising one
11. Serum PSA of ≥ 0.2 ng/mL at 6 to 8 months after systemic treatment initiation
12. Testosterone level < 50 ng/dl or < 1.7 nmol/L
13. Be fit enough for 177Lu-vipivotide tetraxetan treatment:
- Adequate bone marrow function: hemoglobin ≥90 g/L (in absence of red blood cell
transfusion within 4 weeks prior to randomization), absolute neutrophil count
≥1.5 x10⁹/L, platelet count >100 x10⁹/L
- Adequate liver function: aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) ≤2.0 x upper limit of normal (ULN), or ≤ 5.0 x ULN in
the presence of liver metastases; bilirubin <1.5 x ULN (unless known or
suspected Gilbert syndrome, then <3 x ULN is permitted)
- Adequate renal function: calculated creatinine clearance ≥ 50 ml/min (using the
MDRD or CKD EPI method).
14. For sexually active men with female partners of reproductive potential or with
pregnant women, agreement to use a condom with another effective contraceptive
method during trial participation and up to 14 weeks after study treatment
completion.
15. Affiliated to the social security system or in possession of equivalent private
health insurance (according to local regulations for participation in clinical
trials).
16. Willing and able to comply with the protocol for the duration of the trial including
undergoing treatment and scheduled visits, and examinations including follow-up.
All of the following criteria must be met ahead of randomization to satisfy trial
eligibility requirements:
1. Signed a written informed consent form prior to any trial specific procedures.
Note: In case of physical incapacitation, a trusted representative of their choice,
which is not the Investigator or sponsor, can sign on the behalf of the patients.
2. Aged ≥18 years old
3. Life expectancy > 6 months as per investigator estimate
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
5. Men with histologically or cytologically confirmed adenocarcinoma of the prostate
6. De novo metastatic disease defined by clinical or radiographic evidence of
metastases at diagnosis (i.e. before any treatment started). If not available, a
more recent imaging can be used
7. Measurable disease or bone lesions evaluable according to PCWG3 criteria. Patients
with doubtful bone metastases are not eligible
8. A pre-randomization 68Ga-PSMA-11 PET/CT scan performed within 4 weeks prior to
randomization in the trial.
FDG PET scan is not required for this protocol. All patients will be treated
independently from the results of pre-randomization PSMA PET scan: patients with
PSMA-positive or PSMA-negative disease according to PROMISE 2.0 criteria are
eligible.
9. Have 6 to 8 months of previous AND ongoing standard systemic treatment for prostate
cancer consisting in either:
- ADT with an androgen receptor signaling inhibitor (ARSI) (i.e., abiraterone
(plus prednisone), or apalutamide or enzalutamide) ± radiotherapy **
- ADT with docetaxel* plus an ARSI (i.e. abiraterone (plus prednisone), or
darolutamide,) ± radiotherapy**
Note:
*Docetaxel must have been stopped at least 4 weeks ahead of randomization.
** Previous radiotherapy to the primary tumor and/or to the metastases is accepted
as long as it was not PSMA-based and must has been completed at least 4 weeks ahead
of randomization.
10. Stable or declining PSA level but not a rising one
11. Serum PSA of ≥ 0.2 ng/mL at 6 to 8 months after systemic treatment initiation
12. Testosterone level < 50 ng/dl or < 1.7 nmol/L
13. Be fit enough for 177Lu-vipivotide tetraxetan treatment:
- Adequate bone marrow function: hemoglobin ≥90 g/L (in absence of red blood cell
transfusion within 4 weeks prior to randomization), absolute neutrophil count
≥1.5 x10⁹/L, platelet count >100 x10⁹/L
- Adequate liver function: aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) ≤2.0 x upper limit of normal (ULN), or ≤ 5.0 x ULN in
the presence of liver metastases; bilirubin <1.5 x ULN (unless known or
suspected Gilbert syndrome, then <3 x ULN is permitted)
- Adequate renal function: calculated creatinine clearance ≥ 50 ml/min (using the
MDRD or CKD EPI method).
14. For sexually active men with female partners of reproductive potential or with
pregnant women, agreement to use a condom with another effective contraceptive
method during trial participation and up to 14 weeks after study treatment
completion.
15. Affiliated to the social security system or in possession of equivalent private
health insurance (according to local regulations for participation in clinical
trials).
16. Willing and able to comply with the protocol for the duration of the trial including
undergoing treatment and scheduled visits, and examinations including follow-up.
Patients presenting with any of the following criteria are not eligible:
1. Any evidence of cancer progression (including a rising PSA level, clinical
progression, or radiological progression)
2. Prior or concurrent PSMA-based radioligand therapy or other PSMA target treatments
3. Known hypersensitivity to the components of the study therapy or its analogs
4. Any condition preventing the use of the standard of care and/or specific
experimental treatments tested in the trial
5. Any of the following within 6 months before randomization: stroke, myocardial
infraction, severe/unstable angina pectoris, coronary/peripheral artery bypass
graft, congestive heart failure New York Heart Association (NYHA) Class III or IV
6. Hypertension not controlled by an anti-hypertensive treatment (systolic blood
pressure [sBP] ≥ 160 mmHg or diastolic blood pressure [dBP] ≥ 95 mmHg, 3 consecutive
measures taken 5 minutes apart)
7. Severe or uncontrolled concurrent disease, infection or co-morbidity
8. Pathological findings consistent with small cell carcinoma of the prostate
9. History of malignancy within 3 years of the current diagnosis with the exception of
successfully treated basal cell or squamous cell skin carcinoma
10. Ongoing participation in another clinical trial involving an investigational
product.. Treatment with an investigational product must have ended within 28 days
prior to the day of randomization
11. Patients unwilling or unable to comply with the medical follow-up required by the
trial because of geographic, familial, social, or psychological reasons
12. Persons deprived of their liberty or under protective custody or guardianship