Response Evaluation Criteria in PSMA PET/CT (RECIP 1.0) in Metastatic Castration-resistant Prostate Cancer.
Andrei Gafita, Loïc Djaileb, Isabel Rauscher...
https://pubmed.ncbi.nlm.nih.gov/37432081Actively Recruiting
Age: 18Years +
MALE
ID06828263
Prospective Evaluation of Imaging Response Biomarkers During [177Lu]Lu-PSMA in Metastatic Castration-resistant Prostate Cancer
Led by University Hospital, Grenoble · Updated on 2025-12-26
130
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Grenoble
Lead Sponsor
J
Johns Hopkins University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the use of Lutetium-177 (177Lu) prostate-specific membrane antigen (PSMA) imaging to evaluate treatment response in patients with metastatic castration-resistant prostate cancer (mCRPC). This study focuses on the potential of LuPSMA-SPECT/CT, a cost-effective imaging method, to serve as an early marker for assessing response to 177Lu-PSMA therapy, which has been approved for late-stage PSMA-positive mCRPC. The study aims to improve early treatment decisions and patient care by detecting tumor progression sooner. Participants will receive 177Lu-PSMA therapy and undergo serial LuPSMA-SPECT/CT imaging after each treatment dose. The study will also assess interim PSMA-PET/CT scans performed 10 weeks after treatment initiation. Researchers will compare the cost-effectiveness and clinical impact of SPECT/CT versus PET/CT imaging methods and explore additional PET imaging with [18F]FDG to evaluate response. The study spans from treatment start to at least 12 months after treatment initiation. During the study, participants will have imaging scans, including LuPSMA-SPECT/CT and PSMA-PET/CT, to monitor tumor response and progression. Researchers will analyze tumor burden and imaging parameters to confirm the prognostic value of these imaging techniques for overall survival and progression-free survival. The study also evaluates agreement between image readers to ensure consistency. Participant involvement includes regular imaging and clinical assessments over the course of a year or longer.
CONDITIONS
Brief Title
Prospective Evaluation of Imaging Response Biomarkers During [177Lu]Lu-PSMA in Metastatic Castration-resistant Prostate Cancer
Who Can Participate
Age: 18Years +
MALE
Eligibility Criteria
You may qualify if you...
- Adult aged 18 or older with proven adenocarcinoma of the prostate
- Diagnosis of progressive metastatic castration-resistant prostate cancer
- Progression or intolerance on a novel anti-androgen therapy such as abiraterone, enzalutamide, apalutamide, or darolutamide
- Prior therapy with at least one taxane-based chemotherapy or patient symptomatic and unfit for chemotherapy
- Eastern Cooperative Oncology Group (ECOG) Performance status 0 to 2
You will not qualify if you...
- Patient opposed to the use of his data for clinical research
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - From treatment initiation to at least 12 months after treatment initiation
Participants undergo imaging assessments to evaluate response biomarkers during treatment.
Multiple imaging visits including SPECT/CT and PET/CT scans
Trial Site Locations
Total: 1 location
1
CHU Grenoble Alpes
Grenoble, France, 38053
Actively Recruiting
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Research Team
L
Loïc DJAÏLEB, PU-PH
M
Marine FAURE
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Evaluation of 177Lu-PSMA-617 SPECT/CT Quantitation as a Response Biomarker Within a Prospective 177Lu-PSMA-617 and NOX66 Combination Trial (LuPIN).
Sarennya Pathmanandavel, Megan Crumbaker, Bao Ho...
https://pubmed.ncbi.nlm.nih.gov/36008120177Lu-PSMA SPECT Quantitation at 6 Weeks (Dose 2) Predicts Short Progression-Free Survival for Patients Undergoing 177Lu-PSMA-I&T Therapy.
Nikeith John, Sarennya Pathmanandavel, Megan Crumbaker...
https://pubmed.ncbi.nlm.nih.gov/36215568Prognostic utility of RECIP 1.0 with manual and AI-based segmentations in biochemically recurrent prostate cancer from [68Ga]Ga-PSMA-11 PET images.
Jake Kendrick, Roslyn J Francis, Ghulam Mubashar Hassan...
https://pubmed.ncbi.nlm.nih.gov/37550494PSMA PET/CT for Response Assessment and Overall Survival Prediction in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Androgen Receptor Pathway Inhibitors.
Qaid Ahmed Shagera, Ioannis Karfis, Paulus Kristanto...
https://pubmed.ncbi.nlm.nih.gov/37770114Novel Framework for Treatment Response Evaluation Using PSMA PET/CT in Patients with Metastatic Castration-Resistant Prostate Cancer (RECIP 1.0): An International Multicenter Study.
Andrei Gafita, Isabel Rauscher, Manuel Weber...
https://pubmed.ncbi.nlm.nih.gov/35422442Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer.
Oliver Sartor, Johann de Bono, Kim N Chi...
https://pubmed.ncbi.nlm.nih.gov/34161051