Clinical trial · Interventional
Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy
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
NCT04430192CI-TRIAL-00082386LuTectomyactive not recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 177Lu-PSMA-617 | Drug | Lutetium (177lu) Vipivotide Tetraxetan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 177Lu-PSMA-617 followed by prostatectomy
- description
- 177Lu-PSMA-617 followed by prostatectomy
- interventionNames
- Drug: 177Lu-PSMA-617
Primary outcomes (1)
- measure
- 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
- timeFrame
- Determined using imaging at 4, 24 and 96 hrs after administration of Lu-PSMA
- description
- Establishing the absorbed radiation dose in the prostate and involved lymph nodes (Gy)
Secondary outcomes (8)
- measure
- To evaluate the imaging response to therapy using PSMA-PET
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDEapen 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