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

NCT04430192 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: 19_245
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Conditions

Prostatic Neoplasms

Keywords

177Lu-PSMA; Prostate Cancer; Radionuclide Therapy; Theranostics; prostate specific membrane antigen

Outcome Measures

Primary Outcomes (1)

• To determine the radiation absorbed dose in the prostate and involved lymph nodes following one or two administrations of Lu-PSMA in men with HRCaP prior to radical prostatectomy

  Establishing the absorbed radiation dose in the prostate and involved lymph nodes (Gy)

  Determined using imaging at 4, 24 and 96 hrs after administration of Lu-PSMA

Secondary Outcomes (8)

• To evaluate the imaging response to therapy using PSMA-PET

  6 weeks following final administration of Lu-PSMA

• To evaluate the biochemical response to therapy

  6 weeks following final administration of Lu-PSMA

• To evaluate pathologic response in the prostate following prostatectomy

  After prostatectomy, approximately 6 weeks from final Lu-PSMA administration

• To evaluate toxicity of Lu-PSMA

  Until 8 weeks after prostatectomy

• To evaluate the surgical safety of prostatectomy following Lu-PSMA

  Until 8 weeks after prostatectomy

Other Outcomes (3)

• To determine the time to biochemical recurrence (BCR) [PSA>0.2 ng/mL post-RP]

  To be determined as it is an exploratory endpoint up to 3 years

• To determine the relationship between PSMA PET imaging parameters and absorbed dose

  baseline PSMA PET within 45 days of Lu-PSMA administration

• To identify tissue and blood and serum biomarkers associated with clinical outcomes

  To be determined as it is an exploratory endpoint up to 3 years

Study Arms (1)

177Lu-PSMA-617 followed by prostatectomy

EXPERIMENTAL

177Lu-PSMA-617 followed by prostatectomy

Drug: 177Lu-PSMA-617

Interventions

177Lu-PSMA-617 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.

Also known as: 177Lu-PSMA, [177Lu]Lu-PSMA-617, Lu-PSMA

177Lu-PSMA-617 followed by prostatectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peter MacCallum Cancer Centre, Australia: lead
• Movember Foundation: collaborator
• Medical Research Future Fund: collaborator
• Endocyte: collaborator
• E.J. Whitten Foundation Prostate Cancer Research Centre: collaborator

Study Sites (1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Related Publications (1)

• 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.

  PMID: 37891072 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Pluvicto

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Declan Murphy

  Peter MacCallum Cancer Centre, Australia

  PRINCIPAL INVESTIGATOR

• Michael S Hofman

  Peter MacCallum Cancer Centre, Australia

  PRINCIPAL INVESTIGATOR

• John Violet

  Peter MacCallum Cancer Centre, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: June 12, 2020
• Study Start: August 6, 2020
• Primary Completion: December 22, 2022
• Study Completion: August 30, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)