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

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

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