Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy (LuTectomy)

Peter MacCallum Cancer Centre, Australia

Status and phase

Active, not recruiting

Phase 2

Phase 1

Conditions

Prostatic Neoplasms

Treatments

Drug: 177Lu-PSMA-617

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04430192

19_245

Details and patient eligibility

About

This clinical trial will evaluate the dosimetry, efficacy and toxicity of Lu-PSMA in men with high PSMA-expressing high-risk localized or locoregional advanced prostate cancer (HRCaP) undergoing radical prostatectomy (RP) and pelvic lymph node dissection (PLND)

Full description

This open label, phase I/II non-randomised clinical trial will evaluate the dosimetry, efficacy and toxicity of Lu-PSMA in men with high PSMA-expressing high-risk localized or locoregional advanced prostate cancer (HRCaP) undergoing radical prostatectomy (RP) and pelvic lymph node dissection (PLND). Patients will receive one or two cycles of 177Lu-PSMA followed by surgery. The primary objective is to determine the radiation absorbed dose in the prostate and involved lymph nodes. Secondary objectives include evaluating imaging response to therapy using PSMA-PET, biochemical response, pathological response, adverse effects of Lu-PSMA and surgical safety, and health-related Quality of Life (QoL).

Enrollment

20 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.