Prostate Cancer Clinical Trial
Official title:
Exploratory, Single-institution Study, Comparing 68Ga-RM2 PET/CT Versus 68Ga-PSMA-617 PET/CT in Patients Diagnosed With Prostate Cancer of Various Metastatic Risks Candidates for Radical Prostatectomy - "UROPET"
Patients with primary prostate cancer (low, intermediate or high metastatic risk) for whom
radical prostatectomy is indicated, will be invited to participate to the present study.
Positron Emission Tomography coupled with scanner (PET-CT) using a radiotracer : 68Ga-RM2 and
Positron Emission Tomography coupled with scanner (PET-CT) using another radiotracer :
68Ga-PSMA-617, will be scheduled.
Approximately 15% of men with prostate cancer have high-risk disease at diagnosis. For these
patients the accuracy of initial staging is of critical importance for treatment
decision-making.
Recommended imaging modalities for initial staging include computerized tomography (CT) scan,
bone scan, and Magnetic Resonance Imaging (MRI). In addition to initial work-up, 18F-Choline
Positron Emission Tomography coupled with scanner (PET-CT) may be proposed in some high-risk
patients but its sensitivity for lymph node detection remains limited.
Nowadays, new radiotracers are becoming available for prostate cancer imaging. Among them,
PET-CT imaging with radiolabeled ligands of prostate specific membrane antigen (PSMA) could
be more sensitive and more specific for the detection of lymph node metastasis in high-risk
cancers, as it is the case with radiolabeled PSMA-617 which has demonstrated very promising
results in men with metastatic prostate cancer in recent studies.
Therefore, PET imaging with 68Ga-PSMA-617 may participate to optimize work-up in the staging
of high-risk patients.
Another family of radiopharmaceuticals aimed to target the Gastrin-Releasing Peptide Receptor
(GRP-R) which is overexpressed in low-grade prostatic carcinomas. GRP-R expression is
correlated with androgen receptor expression and with better outcomes.
Various radiolabeled GRP analogues have been developed and one of them, 68Ga-RM2, has shown
very promising preclinical results. A study in 14 patients with prostate cancer showed
encouraging results as related to the detection of primary prostate cancer and metastatic
lymph nodes as well as in detection of local recurrence in the prostate bed and nodal
relapse. However, 68Ga-RM2 failed to show some bone metastases in hormone-refractory
patients. 68Ga-RM2 has also been recently used and compared to 68Ga-PSMA-11 for targeting
biochemically recurrent prostate cancer. These radiotracers may offer complementary
performances in lymph nodes detection due to their distinct pharmacokinetics.
Since 68Ga-RM2 and 68Ga-PSMA-617 target different cell populations, combining these two
radiopharmaceuticals in patients could be of additional value.
The aim of this pilot study is to compare 68Ga-PSMA-617 PET/CT to 68Ga-RM2 PET/CT in 24
patients with prostate cancer of various progression risks to better understand how they
could performed a metastatic risk mapping and how they could be used (or combined) in
clinical practice.
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