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

Universitaire Ziekenhuizen KU Leuven

Status

Enrolling

Conditions

Prostate Cancer

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03327675

S59428

2016-003089-14 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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

Enrollment

188 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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