Trial Title:
Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)
NCT ID:
NCT06496581
Condition:
Prostate Cancer Metastatic
Conditions: Official terms:
Prostatic Neoplasms
Prednisone
Docetaxel
Conditions: Keywords:
Genital Diseases, Male
Prostatic Diseases
Hormones
177Lu-PSMA-617
PSA
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Phase III, international, multicenter, randomized
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
177Lu-PMSA-617
Description:
Once every 6 weeks, 7400 MBq 177Lu-PMSA-617 will be administered for up to a total of 4
cycles.
Arm group label:
Arm B (Experimental arm): 177Lu-PMSA-617 + SoC
Other name:
Pluvicto®
Intervention type:
Drug
Intervention name:
Standard of Care
Description:
ADT, abiraterone and each ARSI (Apalutamide, Darolutamide, Enzalutamide) will be
administrated according to the standard of care
Arm group label:
Arm A (Control arm): Standard of Care (SoC) alone
Arm group label:
Arm B (Experimental arm): 177Lu-PMSA-617 + SoC
Other name:
ADT with an ARSI (i.e. abiraterone + prednisone, or apalutamide, or enzalutamide) ± radiotherapy* or ADT with docetaxel* plus an ARSI (i.e abiraterone + prednisone, or darolutamide,) ± radiotherapy
Summary:
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).
Detailed description:
The study plans to enroll 500 patients over 63 months who will be randomized (1:1) to
receive either: (i) Control arm: SoC (ADT+ ARSI (second-generation androgen receptor
signaling inhibitors) +/- RT or ADT+ ARSI +/- RT) or (ii) Experimental arm:
177Lu-PSMA-617 + SoC (ADT+ ARSI +/- RT or ADT+ docetaxel + ARSI +/- RT). Response to
treatment will be assessed according to the Prostate Cancer Clinical Trials Working Group
3 (PCWG3) criteria. Treatment will be continued at least until castration-resistant
prostate cancer (CRPC) stage is reached, defined by evidence of cancer progression
(either a confirmed PSA rise or a radiographic progression) with serum testosterone being
at castrated levels (<0.50 ng/mL). This systemic treatment may be continued after CRPC is
reached, based on patient benefit and the investigator's opinion. Treatment may also be
terminated at the initiative of either the patient or the investigator for any reason
that would be beneficial to the patient, including: unacceptable toxicity, intercurrent
conditions that preclude continuation of treatment, or patient request. At the end of
treatment period, the follow-up period will last for 102 months (8.5 years). The overall
trial duration, including the follow-up, is expected to last 18.5 years.
Criteria for eligibility:
Criteria:
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.
Exclusion Criteria:
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
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut de Cancérologie de l'Ouest
Address:
City:
Angers
Country:
France
Contact:
Last name:
Elouen Boughalem, MD
Investigator:
Last name:
Elouen Boughalem, MD
Email:
Principal Investigator
Facility:
Name:
Institut Bergonié
Address:
City:
Bordeaux
Country:
France
Contact:
Last name:
Paul Schwartz, MD
Investigator:
Last name:
Paul Schwartz, MD
Email:
Principal Investigator
Facility:
Name:
CHRU Brest
Address:
City:
Brest
Country:
France
Contact:
Last name:
Friederike Schlurmann, MD
Investigator:
Last name:
Friederike Schlurmann, MD
Email:
Principal Investigator
Facility:
Name:
Centre Francois Baclesse
Address:
City:
Caen
Country:
France
Contact:
Last name:
Florence Joly, MD
Investigator:
Last name:
Florence Joly, MD
Email:
Principal Investigator
Facility:
Name:
CHU Henri Mondor
Address:
City:
Créteil
Country:
France
Contact:
Last name:
Caroline Saldana, MD
Investigator:
Last name:
Caroline Saldana, MD
Email:
Principal Investigator
Facility:
Name:
Centre Georges-François Leclerc
Address:
City:
Dijon
Country:
France
Contact:
Last name:
Clément Drouet, MD
Investigator:
Last name:
Clément Drouet, MD
Email:
Principal Investigator
Facility:
Name:
CHU Grenoble
Address:
City:
Grenoble
Country:
France
Contact:
Last name:
Loic Djaileb, MD
Investigator:
Last name:
Loic Djaileb, MD
Email:
Principal Investigator
Facility:
Name:
Centre Léon Berard
Address:
City:
Lyon
Country:
France
Contact:
Last name:
Aude Flechon, MD
Investigator:
Last name:
Aude Flechon, MD
Email:
Principal Investigator
Facility:
Name:
Institut Paoli-Calmettes
Address:
City:
Marseille
Country:
France
Contact:
Last name:
Gwenaelle Gravis, MD
Investigator:
Last name:
Gwenaelle Gravis, MD
Email:
Principal Investigator
Facility:
Name:
CHRU Nancy
Address:
City:
Nancy
Country:
France
Contact:
Last name:
Pierre Olivier, MD
Investigator:
Last name:
Pierre Olivier, MD
Email:
Principal Investigator
Facility:
Name:
Centre Antoine Lacassagne
Address:
City:
Nice
Country:
France
Contact:
Last name:
Delphine Borchiellini, MD
Investigator:
Last name:
Delphine Borchiellini, MD
Email:
Principal Investigator
Facility:
Name:
Hôpital Cochin
Address:
City:
Paris
Country:
France
Contact:
Last name:
Olivier Hullard, MD
Investigator:
Last name:
Olivier Hullard, MD
Email:
Principal Investigator
Facility:
Name:
Hôpital Saint Louis
Address:
City:
Paris
Country:
France
Contact:
Last name:
Hélène Gauthier
Investigator:
Last name:
Hélène Gauthier, MD
Email:
Principal Investigator
Facility:
Name:
Institut Curie
Address:
City:
Paris
Country:
France
Contact:
Last name:
Zahra Castel-Ajgal, MD
Investigator:
Last name:
Zahra Castel-Ajgal, MD
Email:
Principal Investigator
Facility:
Name:
Centre Eugène Marquis
Address:
City:
Rennes
Country:
France
Contact:
Last name:
Laurence Crouzet, MD
Investigator:
Last name:
Laurence Crouzet, MD
Email:
Principal Investigator
Facility:
Name:
Centre Henri Becquerel
Address:
City:
Rouen
Country:
France
Contact:
Last name:
David Tonnelet, MD
Investigator:
Last name:
David Tonnelet, MD
Email:
Principal Investigator
Facility:
Name:
CHU Rouen
Address:
City:
Rouen
Country:
France
Contact:
Last name:
Laetitia Augusto, MD
Investigator:
Last name:
Laetitia Augusto, MD
Email:
Principal Investigator
Facility:
Name:
Institut Curie
Address:
City:
Saint-Cloud
Country:
France
Contact:
Last name:
Capucine Richard, MD
Investigator:
Last name:
Capucine Richard, MD
Email:
Principal Investigator
Facility:
Name:
Institut de Cancérologie de l'Ouest
Address:
City:
Saint-Herblain
Country:
France
Contact:
Last name:
Emmanuelle Bompas, MD
Investigator:
Last name:
Emmanuelle Bompas, MD
Email:
Principal Investigator
Facility:
Name:
CHU Saint Etienne
Address:
City:
Saint-Priest-en-Jarez
Country:
France
Contact:
Last name:
Pierre Cornillon, MD
Investigator:
Last name:
Pierre Cornillon, MD
Email:
Principal Investigator
Facility:
Name:
ICANS
Address:
City:
Strasbourg
Country:
France
Contact:
Last name:
Philippe Barthelemy, MD
Investigator:
Last name:
Philippe Barthelemy, MD
Email:
Principal Investigator
Facility:
Name:
IUCT Oncopole
Address:
City:
Toulouse
Country:
France
Contact:
Last name:
Loic Mourey, MD
Investigator:
Last name:
Loic Mourey, MD
Email:
Principal Investigator
Facility:
Name:
CHRU Tours
Address:
City:
Tours
Country:
France
Contact:
Last name:
Mathilde Cancel, MD
Investigator:
Last name:
Mathilde Cancel, MD
Email:
Principal Investigator
Facility:
Name:
Institut de Cancérologie de Lorraine
Address:
City:
Vandœuvre-lès-Nancy
Country:
France
Contact:
Last name:
Vincent MASSARD, MD
Investigator:
Last name:
Vincent MASSARD, MD
Email:
Principal Investigator
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Country:
France
Contact:
Last name:
Karim FIZAZI, MD
Investigator:
Last name:
Karim Fizazi, MD
Email:
Principal Investigator
Start date:
August 1, 2024
Completion date:
August 1, 2039
Lead sponsor:
Agency:
UNICANCER
Agency class:
Other
Collaborator:
Agency:
Novartis
Agency class:
Industry
Source:
UNICANCER
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06496581
