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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03327675
• Other study ID #: S59428
• Secondary ID: 2016-003089-14
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2017
• Est. completion date: December 2022

Study information

• Verified date: May 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Karolien Goffin, MD, PhD
• Phone: 003216343714
• Email: karolien.goffin[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• 68Ga-PSMA (HBED-CC) PET
68Ga-PSMA PET/MR

Locations

Country	Name	City	State
Belgium	UZLeuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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