Tb-PSMA-I&T Radionuclide Before Radical Prostatectomy in Patients With Locally Advanced Prostate Cancer - TbeforePROST Trial.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tb-PSMA-I&T (Tb-PSMA).
- Who it may be relevant to
- Registry conditions: High Risk Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Tb-PSMA-I&T Radionuclide Neo-Adjuvant Treatment in Patients With Locally Advanced Prostate Cancer Before Radical Prostatectomy: TbeforePROST Trial.
Overview
This is a multi-disciplinary collaboration between urologists, oncologists and nuclear medicine physicians from Beilinson hospital at Rabin Medical Center to address the major therapeutic challenge of locally advanced prostate cancer. Our aim is to evaluate the use of a novel treatment (Tb-PSMA) prior to the surgical removal of the prostate. This treatment has already shown initial promising results in patients with metastatic prostate cancer but has never been tested for locally advanced disease before surgery.
Interventions
- Drug Tb-PSMA-I&T (Tb-PSMA)
Terbium-161 produce beta emission with the addition of Auger electrons which have higher linear energy transfer and a very short range. By that it has the potential to improve local and distal (micro-metastatic disease) efficacy with a similar safety profile. It will be given to patients with high risk locally advanced prostate cancer prior to Radical prostatectomy
Primary outcome measures
- Number of Tb-PSMA adverse effects measured by CTCAE v4.0 and number of surgical complications - measured by the Clavien-Dindo Classification (2009) [Time frame: 1 year]
- Surgical and clinical safety [Time frame: 1 year]
Secondary outcome measures (1)
- Immediate oncological outcomes as measured by number of patients with positive surgical margins and number of patients who achieved biochemical complete response [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- Male aged 18 years and older.
- Patients with high-risk localized prostate cancer (cT3/4 and/or Gleason score ≥ eight and/or prostate biopsy or PSA ≥ 20 ng/dl)
- High PSMA expression was confirmed according to PROMISE V2 8
- Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status score of 1 or lower and a life expectancy of > 10 years.
Exclusion criteria
- Platelet count lower than 150×103/µl
- white blood cell count lower than 4×103/µl,
- haemoglobin concentration lower than 12mg/dl.
- albumin concentration lower than 3.5 g/dl.
- glomerular filtration rate (GFR) lower than 40 mL/min.
- usage of nephrotoxic drugs
- distant metastatic disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Beilinson Hospital — Petah Tikva
Identifiers
NCT: NCT07208240 · RMC 833-23