Study of the Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Radionuclide Therapy Prior to Radical Prostatectomy in Men With High-risk Localised Prostate Cancer

Condition: Prostatic Neoplasms

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04430192

Sponsor: Peter MacCallum Cancer Centre, Australia

Phase: Phase 1/Phase 2

Eligibility:

Inclusion Criteria:

Patient has provided written informed consent.
Male patient aged 18 or over at the time of screening
Histologically confirmed adenocarcinoma of the prostate, in a patient scheduled for RP and PLND with curative intent
High or high-intermediate risk localised or locoregional prostate cancer (HRCaP) by European Association of Urology (EAU) criteria, including any of the following:
PSA > 20 ng/mL
ISUP grade group 3-5
Clinical T-stage by digital rectal examination (DRE) of T2c or higher
N1 disease (involvement of lymph nodes at or below the bifurcation of the common iliac arteries)
defined radiologically (CT/ MRI, or PSMA PET).
High PSMA avidity on 68Ga-PSMA PET/CT, defined as an SUVmax of ≥ 20
Normal baseline haematological function; haemoglobin 13.5-17.5g/dl), total white blood cell count (4-11 x 109/l), platelets (150-400 x 109/l), neutrophils (2-7.5 x 109/l) and lymphocytes (1-4 x 109/l)
Normal baseline serum biochemistry; sodium 135-145 nmol/l, potassium 3.5-5 nmol/l, chloride 98-108 nmol/l, urea 3-9.2 nmol/l, creatinine 60-120μmol/l
Willing and able to comply with all study requirements including all treatments and required assessments including follow up

Exclusion Criteria:

Prostate cancer with significant neuroendocrine or other rare variant pathology
Prior treatment for prostate cancer including radiotherapy and/or androgen deprivation therapy.
Evidence of metastatic disease involving bone, viscera, or lymph nodes superior to the common iliac bifurcation based on CT, MRI, WBBS or PSMA PET/CT.
Renal impairment [GFR < 60mL/min].
Sjogren’s syndrome.
A history of or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient’s participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.