A Study of 68Ga-GRP PET/CT for Imaging in Low and Intermediate Risk Prostate Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    80
  • sponsor
    Xiangya Hospital of Central South University
Updated on 25 October 2021

Summary

Patients with primary low and intermediate risk prostate cancer (PCa) for whom radical prostatectomy are indicated, will be invited to participate to the present study.

The aim of this study is to investigate the clinical value of 68Ga-GRP positron emission tomography / computed tomography (PET/CT) compared to 68Ga-PSMA PET/CT in patients with low and intermediate risk PCa.

Description

Prostate cancer (PCa) is the second-most common cancer among men across the world, and a significant cause of death in many regions. Different stages of PCa directly affect both the therapeutic schedule and patient prognosis.

Recommended imaging modalities for initial staging include computerized tomography (CT) scan, bone scan, and Magnetic Resonance Imaging (MRI). In addition to initial work-up, Gallium-68 prostate-specific membrane antigen positron emission tomography/computer tomography (68Ga-PSMA PET/CT) is a relatively new nuclear imaging modality, showing high sensitivity and specificity. Recently, several studies have investigated the role of 68Ga-PSMA PET/CT in a first-line diagnostic setting, especially in patients with high-risk and biochemically recurrent PCa.

Therefore, PET imaging with 68Ga-PSMA 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 early stage PCa. Various radiolabeled GRP analogues have been developed and shown encouraging results as related to the detection of primary PCa in preclinical study. However, 68Ga-GRP failed to detect some bone metastases in hormone-refractory patients. A prospective study identified that GRPR expression is not associated with Gleason score (GS) and PSMA expression, suggesting that 68Ga-GRP and 68Ga-PSMA PET/CT may be complementary in various risks of PCa diagnosis.

The aim of this pilot study is to compare 68Ga-PSMA PET/CT to 68Ga-GRP PET/CT in patients with PCa of low and intermediate risk to better understand how 68Ga-PSMA and 68Ga-GRP PET/CT could performed a primary lesion mapping and how 68Ga-PSMA and 68Ga-GRP PET/CT could be used (or combined) in clinical practice.

Details
Condition prostate cancers, Prostate Cancer, Early, Recurrent, Prostatic disorder, Prostate Cancer, Malignant neoplasm of prostate, prostate carcinoma, Prostate Disorders
Treatment 68Ga-PSMA PET/CT, Drug: 68Ga-PSMA PET/CT; Drug: 68Ga-GRP PET/CT, 68Ga-GRP PET/CT
Clinical Study IdentifierNCT05073653
SponsorXiangya Hospital of Central South University
Last Modified on25 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

patients divided in
Patients with low risk prostate cancer (Gleason score 6 and cT1-T2a and Prostate Specific Antigen (PSA) value < 10 ng/mL)
Patients with intermediate risk prostate cancer (Gleason score 7 or cT2b or PSA value 10-20 ng/mL)
Patients with high risk prostate cancer (Gleason > 7 or cT2c or PSA value > 20 ng/mL)
Candidate for radical prostatectomy after discussion in multidisciplinary committee
Written informed consent willingly obtained

Exclusion Criteria

Any kind of previous treatment for prostate cancer (hormonal treatment, EBRT, brachytherapy, cryotherapy, etc)
Patient not candidate for radical prostatectomy and/or unable to benefit from surgery
Patient under legal protection or unable to express its own consent
Patient within exclusion period from another clinical trial
Claustrophobia (unable to accept PET/CT scanning)
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