High Precision Imaging of Prostate Specific Membrane Antigen for Personalized Treatment in Prostate Cancer

Study Overview
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Brief Summary
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This is an Investigator Initiated, non-commercial, single center, non-randomized, single arm, open label pilot study on 194 patients. The patients are affected by prostate cancer but in two different clinical settings. The first group is characterized by patients who are going to be operated of radical prostatectomy and they will undergo the study imaging preoperatively. The second group experiences biochemical relapse after primary treatment.

Detailed Description
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Novel, sensitive tools, such as 68Ga-PSMA PET imaging, have great potential for very early disease detection and open the possibility of early curative local salvage treatment (with surgery, radiotherapy or a combination of both). This project will moreover provide important insights into the biodistribution and dosimetry of 68Ga-PSMA, opening possibilities of 90-Yttrium or 177-Lutetium-PSMA-based radionuclidetherapy of patients with metastatic PC in the future. The study consists of 2 work units (WU): Work-unit 1: Patients at high risk for nodal involvement prior to radical prostatectomy with extended lymph node dissection Work-unit 2: Biochemical recurrence after initial treatment with curative intent

Official Title
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High Precision Imaging of Prostate Specific Membrane Antigen for Personalized Treatment in Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: 68Ga-PSMA (HBED-CC) PET


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Work-unit 1 age < 75 years of age, with histologically proven invasive adenocarcinoma of the prostate a risk of equal or more than 5% of lymph node metastasis (intermediate to high risk disease), according to the Briganti nomogram (1) scheduled to undergo radical prostatectomy with extended lymph node dissection Work-unit 2 histologically proven diagnosis of prostate cancer biochemical relapse (two consecutive PSA≥0.2 ng/ml) of prostate cancer following radical local prostate treatment WHO performance state 0-1 age > 18 years old Exclusion criteria Work-unit 1 involvement of pelvic lymph nodes assessed by multi-parametric MRI evidence for bone metastasis assessed by bone scan (if PSA > 20 ng/ml) WHO performance status > 2 previous pelvic irradiation or radical prostatectomy. other malignancy except adequately treated basal cell carcinoma of the skin diagnosed during the last 5 years any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. Work-unit 2 serum testosterone level <50ng/ml symptomatic metastases local relapse on MRI PSA rise while on active treatment with LHRH-agonist, LHRH-antagonist, Anti-androgen, Complete androgen blockade, Oestrogen-antioestrogen therapy previous treatment with cytotoxic agent for PCa treatment during the past month with products known to influence PSA levels (e.g. fluconazole, finasteride, corticosteroids,…) disorder precluding understanding of trial information or informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-PSMA PET/MR<br>Hybrid 68Ga-PSMA PET/MR scan | Other: 68Ga-PSMA (HBED-CC) PET<br>* 68Ga-PSMA PET/MR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 68Ga-PSMA PET/MR imaging accuracy before radical prostatectomy + pelvic lymph node dissection [RP + PLND]. Work unit 1. 68Ga-PSMA PET/MR imaging accuracy in patients with biochemical recurrence after primary treatment. Work unit 2. | Assessment of the sensitivity, specificity, positive and negative predictive | through study completion, an average of 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation of tracer uptake to Gleason scores within the prostate tumor and within metastatic lymph nodes. Work unit 1. | Correlation between tracer uptake and pathology Gleason score | through study completion, an average of 2 year | 
| Comparison of diagnostic accuracy between 68Ga-PSMA PET, MR and combined 68Ga-PSMA PET/MR. Work unit 2. | Assessment of the sensitivity, specificity, positive and negative predictive value | through study completion, an average of 2 year | 
| The evaluation of change in patient management based on imaging results of 68Ga-PSMA PET/MR in patients with biochemical recurrence. Work unit 2. | Proportion of patients with treatments different from follow-up after the evaluation of 68Ga-PSMA PET/MRI | through study completion, an average of 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate-specific membrane antigen, Lymph Node Dissection, Prostatectomy, Positron-Emission Tomography