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Closed (no longer recruiting)Last updated: 30 November 2023

LuTectomy: This trial aims to evaluate a radiation-based treatment in men with prostate cancer who are undergoing surgery for their cancerStudy 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

Clinical summary

Summary

Eligible patients will receive one or two cycles of 177Lu-PSMA followed by surgery (prostatectomy).

Conditions

This trial is treating patients with PSMA-expressing high-risk localized or locoregional advanced prostate cancer (HRCaP).

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

I/II

Trial Acronym

LuTectomy

More information

Trial Identifiers

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Trial sponsor

Peter MacCallum Cancer Centre

Scientific Title

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

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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