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

NCT ID: NCT04430192

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-06
• Study Completion Date: 2025-08-30

Brief Summary

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)

Detailed 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).

Conditions

Prostatic Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

177Lu-PSMA-617 followed by prostatectomy

177Lu-PSMA-617 followed by prostatectomy

Group Type: EXPERIMENTAL

177Lu-PSMA-617

Intervention Type: DRUG

Patients 1-10 will be given 5GBq of 177Lu-PSMA. Patients 11-20 will be given 2 cycles of 5GBq of 177Lu-PSMA, separated by 6 weeks.

Interventions

177Lu-PSMA-617

Patients 1-10 will be given 5GBq of 177Lu-PSMA. Patients 11-20 will be given 2 cycles of 5GBq of 177Lu-PSMA, separated by 6 weeks.

Intervention Type: DRUG

Other Intervention Names

177Lu-PSMA; [177Lu]Lu-PSMA-617; Lu-PSMA

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Movember Foundation

OTHER

Sponsor Role: collaborator

Medical Research Future Fund

OTHER

Sponsor Role: collaborator

Endocyte

INDUSTRY

Sponsor Role: collaborator

E.J. Whitten Foundation Prostate Cancer Research Centre

UNKNOWN

Sponsor Role: collaborator

Peter MacCallum Cancer Centre, Australia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Declan Murphy

Role: PRINCIPAL_INVESTIGATOR

Peter MacCallum Cancer Centre, Australia

Michael S Hofman

Role: PRINCIPAL_INVESTIGATOR

Peter MacCallum Cancer Centre, Australia

John Violet

Role: PRINCIPAL_INVESTIGATOR

Peter MacCallum Cancer Centre, Australia

Locations

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Countries

Australia

References

Eapen RS, Buteau JP, Jackson P, Mitchell C, Oon SF, Alghazo O, McIntosh L, Dhiantravan N, Scalzo MJ, O'Brien J, Sandhu S, Azad AA, Williams SG, Sharma G, Haskali MB, Bressel M, Chen K, Jenjitranant P, McVey A, Moon D, Lawrentschuk N, Neeson PJ, Murphy DG, Hofman MS. Administering [177Lu]Lu-PSMA-617 Prior to Radical Prostatectomy in Men with High-risk Localised Prostate Cancer (LuTectomy): A Single-centre, Single-arm, Phase 1/2 Study. Eur Urol. 2024 Mar;85(3):217-226. doi: 10.1016/j.eururo.2023.08.026. Epub 2023 Oct 26.

Reference Type: DERIVED

PMID: 37891072 (View on PubMed)

Other Identifiers

19_245

Identifier Type: -

Identifier Source: org_study_id