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

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Recruiting

CT.gov ID

NCT03327675

Collaborator

(none)

188

Enrollment

Location

Arm

50.3

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Other: 68Ga-PSMA (HBED-CC) PET	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

188 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Sep 22, 2017

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 68Ga-PSMA PET/MR Hybrid 68Ga-PSMA PET/MR scan	Other: 68Ga-PSMA (HBED-CC) PET 68Ga-PSMA PET/MR

Arm

Intervention/Treatment

Experimental: 68Ga-PSMA PET/MR

Hybrid 68Ga-PSMA PET/MR scan

Other: 68Ga-PSMA (HBED-CC) PET

68Ga-PSMA PET/MR

Outcome Measures

Primary Outcome Measures

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. [through study completion, an average of 2 year]
Assessment of the sensitivity, specificity, positive and negative predictive

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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