Status:
RECRUITING
Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)
Lead Sponsor:
UNICANCER
Collaborating Sponsors:
Novartis
Conditions:
Prostate Cancer Metastatic
Eligibility:
MALE
18-80 years
Phase:
PHASE3
Brief 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 ongo...
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 ...
Eligibility Criteria
Inclusion
- All of the following criteria must be met ahead of randomization to satisfy trial eligibility requirements:
- 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.
- Aged ≥18 years old
- Life expectancy \> 6 months as per investigator estimate
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Men with histologically or cytologically confirmed adenocarcinoma of the prostate
- 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
- Measurable disease or bone lesions evaluable according to PCWG3 criteria. Patients with doubtful bone metastases are not eligible
- 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.
- 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.
- Stable or declining PSA level but not a rising one
- Serum PSA of ≥ 0.2 ng/mL at 6 to 8 months after systemic treatment initiation
- Testosterone level \< 50 ng/dl or \< 1.7 nmol/L
- 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).
- 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.
- Affiliated to the social security system or in possession of equivalent private health insurance (according to local regulations for participation in clinical trials).
- 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
- Patients presenting with any of the following criteria are not eligible:
- Any evidence of cancer progression (including a rising PSA level, clinical progression, or radiological progression)
- Prior or concurrent PSMA-based radioligand therapy or other PSMA target treatments
- Known hypersensitivity to the components of the study therapy or its analogs
- Any condition preventing the use of the standard of care and/or specific experimental treatments tested in the trial
- 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
- 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)
- Severe or uncontrolled concurrent disease, infection or co-morbidity
- Pathological findings consistent with small cell carcinoma of the prostate
- History of malignancy within 3 years of the current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma
- 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
- Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons
- Persons deprived of their liberty or under protective custody or guardianship
Key Trial Info
Start Date :
September 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2039
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06496581
Start Date
September 12 2024
End Date
August 1 2039
Last Update
December 20 2024
Active Locations (25)
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1
Institut de Cancérologie de l'Ouest
Angers, France
2
Institut Bergonié
Bordeaux, France
3
CHRU Brest
Brest, France
4
Centre Francois Baclesse
Caen, France