NCT04430192Active, not recruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 8 Nov 2024
Brief summary (registry, in English)
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)
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 21 May 2020
- Start date
- 6 Aug 2020
- Primary completion date
- 22 Dec 2022
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Diseases
- Prostate cancer
- NCT number
- NCT04430192
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 20
- From 6 Aug 2020 to the primary completion date, 22 Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment for prostate cancer including radiotherapy and/or androgen deprivation therapy.
Other illness
- Prostate cancer with significant neuroendocrine or other rare variant pathology
- 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.
- Sjogren's syndrome.
Lab values
- Renal impairment \[GFR \< 60mL/min\].
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.