Actively Recruiting
Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)
Led by UNICANCER · Updated on 2024-12-20
500
Participants Needed
25
Research Sites
776 weeks
Total Duration
On this page
Sponsors
U
UNICANCER
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent prior to any trial procedures
- Male aged 18 years or older
- Life expectancy greater than 6 months
- ECOG performance status of 2 or less
- Histologically or cytologically confirmed prostate adenocarcinoma
- De novo metastatic disease confirmed by clinical or imaging evidence
- Measurable disease or evaluable bone lesions according to PCWG3 criteria
- 68Ga-PSMA-11 PET/CT scan performed within 4 weeks before randomization
- Received 6 to 8 months of standard systemic treatment including ADT with ARSI, with or without radiotherapy
- Docetaxel stopped at least 4 weeks before randomization if used
- Stable or declining PSA level, not rising
- PSA level at or above 0.2 ng/mL at 6 to 8 months after starting treatment
- Testosterone level below 50 ng/dl or 1.7 nmol/L
- Adequate bone marrow, liver, and kidney function
- Agreement to use contraception if sexually active with partners of reproductive potential
- Affiliated to social security or equivalent health insurance
- Willing and able to follow the study protocol and attend scheduled visits
You will not qualify if you...
- Evidence of cancer progression, including rising PSA or clinical/radiological progression
- Prior or current PSMA-based radioligand therapy or PSMA-targeted treatments
- Known allergy to study treatments or components
- Conditions preventing use of standard or experimental treatments
- Serious cardiovascular events within 6 months before randomization
- Uncontrolled high blood pressure despite treatment
- Severe or uncontrolled diseases, infections, or co-morbidities
- Small cell carcinoma of the prostate
- History of other malignancies within 3 years except treated skin cancers
- Participation in another clinical trial with investigational products within 28 days
- Unable or unwilling to comply with required medical follow-up
- Legal restrictions such as being under protective custody or deprived of liberty
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
Institut de Cancérologie de l'Ouest
Angers, France
Not Yet Recruiting
2
Institut Bergonié
Bordeaux, France
Not Yet Recruiting
3
CHRU Brest
Brest, France
Not Yet Recruiting
4
Centre Francois Baclesse
Caen, France
Not Yet Recruiting
5
CHU Henri Mondor
Créteil, France
Not Yet Recruiting
6
Centre Georges-François Leclerc
Dijon, France
Not Yet Recruiting
7
CHU Grenoble
Grenoble, France
Not Yet Recruiting
8
Centre Léon Berard
Lyon, France
Not Yet Recruiting
9
Institut Paoli-Calmettes
Marseille, France
Actively Recruiting
10
CHRU Nancy
Nancy, France
Not Yet Recruiting
11
Centre Antoine Lacassagne
Nice, France
Not Yet Recruiting
12
Hôpital Cochin
Paris, France
Not Yet Recruiting
13
Hôpital Saint Louis
Paris, France
Not Yet Recruiting
14
Institut Curie
Paris, France
Not Yet Recruiting
15
Centre Eugène Marquis
Rennes, France
Actively Recruiting
16
Centre Henri Becquerel
Rouen, France
Not Yet Recruiting
17
CHU Rouen
Rouen, France
Not Yet Recruiting
18
Institut Curie
Saint-Cloud, France
Not Yet Recruiting
19
Institut de Cancérologie de l'Ouest
Saint-Herblain, France
Not Yet Recruiting
20
CHU Saint Etienne
Saint-Priest-en-Jarez, France
Not Yet Recruiting
21
ICANS
Strasbourg, France
Not Yet Recruiting
22
IUCT Oncopole
Toulouse, France
Not Yet Recruiting
23
CHRU Tours
Tours, France
Not Yet Recruiting
24
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Not Yet Recruiting
25
Gustave Roussy
Villejuif, France
Actively Recruiting
Research Team
F
Florence TANTOT
CONTACT
C
Catherine LEGER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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