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Prostate Cancer MetastaticPhase 3NCT06496581

Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)

A Phase 3 study testing 177Lu-PMSA-617 in people with Prostate Cancer Metastatic, run by UNICANCER at 25 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years, men only
Conditions the study is for
Prostate Cancer Metastatic
What is being tested?
177Lu-PMSA-617
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
25 sitesFrance
Study dates
12 Sep 2024to 1 Aug 2039
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 27Show fewer
  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Florence TANTOT contact

+33 (1) 73.77.55.43

f-tantot@unicancer.fr

Catherine LEGER contact

+33 (7) 79.83.23.98

c-leger@unicancer.fr

25 sites in 1 country

France25 sites, 25 recruiting

  • Institut de Cancérologie de l'Ouest

    Angers

    Elouen Boughalem, MD

    Elouen Boughalem, MD

    Not yet recruiting

  • Institut Bergonié

    Bordeaux

    Paul Schwartz, MD

    Paul Schwartz, MD

    Not yet recruiting

  • CHRU Brest

    Brest

    Friederike Schlurmann, MD

    Friederike Schlurmann, MD

    Not yet recruiting

  • Centre Francois Baclesse

    Caen

    Florence Joly, MD

    Florence Joly, MD

    Not yet recruiting

  • CHU Henri Mondor

    Créteil

    Caroline Saldana, MD

    Caroline Saldana, MD

    Not yet recruiting

  • Centre Georges-François Leclerc

    Dijon

    Clément Drouet, MD

    Clément Drouet, MD

    Not yet recruiting

  • CHU Grenoble

    Grenoble

    Loic Djaileb, MD

    Loic Djaileb, MD

    Not yet recruiting

  • Centre Léon Berard

    Lyon

    Aude Flechon, MD

    Aude Flechon, MD

    Not yet recruiting

  • Institut Paoli-Calmettes

    Marseille

    Gwenaelle Gravis, MD

    Gwenaelle Gravis, MD

    Recruiting

  • CHRU Nancy

    Nancy

    Pierre Olivier, MD

    Pierre Olivier, MD

    Not yet recruiting

  • Centre Antoine Lacassagne

    Nice

    Delphine Borchiellini, MD

    Delphine Borchiellini, MD

    Not yet recruiting

  • Hôpital Cochin

    Paris

    Olivier Hullard, MD

    Olivier Hullard, MD

    Not yet recruiting

  • Hôpital Saint Louis

    Paris

    Hélène Gauthier

    Hélène Gauthier, MD

    Not yet recruiting

  • Institut Curie

    Paris

    Zahra Castel-Ajgal, MD

    Zahra Castel-Ajgal, MD

    Not yet recruiting

  • Centre Eugène Marquis

    Rennes

    Laurence Crouzet, MD

    Laurence Crouzet, MD

    Recruiting

  • Centre Henri Becquerel

    Rouen

    David Tonnelet, MD

    David Tonnelet, MD

    Not yet recruiting

  • CHU Rouen

    Rouen

    Laetitia Augusto, MD

    Laetitia Augusto, MD

    Not yet recruiting

  • Institut Curie

    Saint-Cloud

    Capucine Richard, MD

    Capucine Richard, MD

    Not yet recruiting

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain

    Emmanuelle Bompas, MD

    Emmanuelle Bompas, MD

    Not yet recruiting

  • CHU Saint Etienne

    Saint-Priest-en-Jarez

    Pierre Cornillon, MD

    Pierre Cornillon, MD

    Not yet recruiting

  • ICANS

    Strasbourg

    Philippe Barthelemy, MD

    Philippe Barthelemy, MD

    Not yet recruiting

  • IUCT Oncopole

    Toulouse

    Loic Mourey, MD

    Loic Mourey, MD

    Not yet recruiting

  • CHRU Tours

    Tours

    Mathilde Cancel, MD

    Mathilde Cancel, MD

    Not yet recruiting

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy

    Vincent MASSARD, MD

    Vincent MASSARD, MD

    Not yet recruiting

  • Gustave Roussy

    Villejuif

    Karim FIZAZI, MD

    Karim Fizazi, MD

    Recruiting

Other trials in France

About this study

Official title: 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

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).

Read the 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.

Being tested
177Lu-PMSA-617, Standard of Care
Keywords
Genital Diseases, Male, Prostatic Diseases, Hormones, 177Lu-PSMA-617, PSA
Medical subject headings
Genital Diseases, Male, Prostatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 177Lu-PMSA-617Drug

    Also called Pluvicto®

    Once every 6 weeks, 7400 MBq 177Lu-PMSA-617 will be administered for up to a total of 4 cycles.

  • Standard of CareDrug

    Also called 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

    ADT, abiraterone and each ARSI (Apalutamide, Darolutamide, Enzalutamide) will be administrated according to the standard of care

Study groups in NCT06496581
Study groupRoleWhat they receive
Arm A (Control arm): Standard of Care (SoC) aloneActive comparatorThe SoC is defined as one the following treatment which was initiated 6 to 8 months ahead of inclusion in this trial and still ongoing at the time of the randomization and continued at least until the CRPC stage is reached.: * ADT with an ARSI (i.e. abiraterone + prednisone, or apalutamide, or enzalutamide) ± radiotherapyª * ADT with docetaxelᵇ plus an ARSI (i.e. abiraterone + prednisone, or darolutamide,) ± radiotherapyª ª Radiotherapy can be part of any standard treatment aforementioned as long as it is not PSMA-based and completed at least 4 weeks ahead of randomization OR planned right after randomization in arm A. ᵇ Whenever docetaxel was part of the systemic treatment initiation, its administration must have been completed at least 4 weeks ahead of randomization.
Receives: Drug: Standard of Care
Arm B (Experimental arm): 177Lu-PMSA-617 + SoCExperimentalOnce every 6 weeks, 7400 MBq 177Lu-PMSA-617 will be administered for up to a total of 4 cycles. Upon 177Lu-PMSA-617 treatment completion, the ongoing standard systemic treatment is to be maintained and continued at least until the CRPC stage is reached. The SoC is defined as one the following treatment which was initiated 6 to 8 months ahead of inclusion in this trial and still ongoing at the time of the randomization: * ADT with an ARSI (i.e. abiraterone + prednisone, or apalutamide, or enzalutamide) ± radiotherapyª * ADT with docetaxelᵇ plus an ARSI (i.e. abiraterone + prednisone, or darolutamide,) ± radiotherapyª ª Radiotherapy can be part of any standard treatment aforementioned as long as it is not PSMA-based completed at least 4 weeks ahead of randomization OR planned right after 177Lu-PSMA-617 in arm B. ᵇ Whenever docetaxel was part of the systemic treatment initiation, its administration must have been completed at least 4 weeks ahead of randomization.
Receives: Drug: 177Lu-PMSA-617; Drug: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause.

    Measured: From randomization to death due to any cause, up to 8.5 years

  2. Radiographic progression-free survival (rPFS)

    Radiographic progression-free survival (rPFS) is defined as the time from randomization to the date of radiographic progression according to PCWG3 criteria by investigator assessment, or death, whichever occurs first.

    Measured: From randomization to radiographic progression or death, up to 8.5 years

Secondary outcomes (9)

  1. Castration-Resistance Prostate Cancer-Free Survival (CRPC-FS)

    Castration-Resistance Prostate Cancer-Free Survival (CRPC-FS) is defined as the time from randomization to the onset of castration-resistance or death from any cause, whichever occurs first.

    Measured: From randomization to onset of castration-resistance or death, up to 8.5 years

  2. Prostate Cancer-Specific Survival (PCSS)

    Prostate Cancer-Specific Survival (PCSS) is defined as the time from the date of randomization to the date of death due to prostate cancer.

    Measured: From the date of randomization to a PCSS event, up to 8.5 years

  3. PSA response

    PSA response will be assessed by the maximum change of PSA (rise or fall) from baseline over the treatment period. A complete PSA response is defined by an undetectable level of serum PSA.

    Measured: From baseline over the treatment period, up to 8.5 years

  4. Skeletal-related event-free survival (SRE-FS)

    Skeletal-related event-free survival (SRE-FS) is defined as the time from the randomization date to the date of diagnosis of either a skeletal-related event (SRE) (fracture, or bone pain requiring radiation therapy, or spinal cord compression, or preventive surgery to the bones) or death, whichever occurs first.

    Measured: From randomization to the onset of a SRE-FS event, up to 8.5 years

  5. Time to severe urinary event (SUE)

    Time to severe urinary event (SUE) is defined as the time from the randomization date to the date of diagnosis of either one of the following SUE, whichever occurs first: urinary retention with need for a urinary catheter, suprapubic catheter, double J stent, nephrostomy, treatment of the prostate by radiotherapy or trans-urethral resection of the prostate (TURP) or prostatectomy done to relieve patients with local symptoms.

    Measured: From randomization to the onset of a SUE event, up to 8.5 years

  6. Time to initiation of first subsequent anti-cancer systemic therapy for CRPC (TTSST1)

    TTSST1 is defined as the time from the randomization date to the date of initiation of the first anti-cancer systemic therapy for CRPC.

    Measured: From randomization to initiation of the first anti-cancer systemic therapy for CRPC, up to 10 years

  7. Time to initiation of second subsequent anti-cancer systemic therapy for CRPC (TTSST2)

    TTSST2 is defined as the time from the randomization date to the date of initiation of the second anti-cancer systemic therapy for CRPC.

    Measured: From randomization to initiation of the second anti-cancer systemic therapy for CRPC, up to 10 years

  8. Efficacy of first subsequent anti-cancer systemic therapy for CRPC

    Efficacy of subsequent anti-cancer systemic therapy for CRPC will be defined as the time from first anti-cancer systemic therapy for CRPC to disease progression or death from any cause, whichever comes first.

    Measured: From first anti-cancer systemic therapy for CRPC to disease progression or death, up to 10 years

  9. Efficacy of second subsequent anti-cancer systemic therapy for CRPC

    Efficacy of second subsequent anti-cancer systemic therapy for CRPC will be defined as the time from second anti-cancer systemic therapy for CRPC to disease progression or death from any cause, whichever comes first.

    Measured: Fromsecond anti-cancer systemic therapy for CRPC to disease progression or death, up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2024
  2. Study start12 Sep 2024
  3. Primary completion1 Feb 2033 (estimated)
  4. Study completion1 Aug 2039 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase III, international, multicenter, randomized
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06496581
Sponsor's protocol ID
UC-GTG-2301 (GETUG-AFU 42)
Other IDs
2022-502408-57-00
Status last verified
Dec 2024
First submitted
3 Jul 2024
Last updated
20 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD can be shared upon request to the sponsor

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 177Lu-PMSA-617 in people with Prostate Cancer Metastatic, run by UNICANCER at 25 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Florence TANTOT (+33 (1) 73.77.55.43, f-tantot@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: From randomization to death due to any cause, up to 8.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06496581.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.

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