177Lu-PSMA as a systemic adjuvant treatment in patients with high and very high risk prostate cancer after radical treatment with locoregional teleradiotherapy and hormone therapy.
- Conditions
- Prostate CancerMedDRA version: 20.0Level: PTClassification code: 10060862Term: Prostate cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-504912-13-00
- Lead Sponsor
- arodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 200
Histopathologically proven high-risk or very-high-risk prostate cancer (according to NCCN v1.2023): 1) high-risk patients: clinical advancement stage cT3a, or 4 or 5 ISUP grading group (with no leading Gleason 5 component), or PSA >20 ng/mL; lack of very-high-risk signs 2) very-high-risk patients: Clinical advancement stage cT3b-cT4, or ISUP 5 grading main group (with leading Gleason 5 component), or 2 or 3 features of high-risk, or >4 cores with 4 or 5 risk group in biopsy samples, In men with procreative ability: consent to the implementation of double barrier contraception method., Completion of radical locoregional treatment – teleradioteraphy., Completion of locoregional treatment within 3 months before inclusion to the study., Giving a written informed consent., ECOG performance status 0 to 2., Age over 18 years., No signs of tumour cells dissemination within 28 days before inclusion to the trial, proven by radiological examinations (CT/or in case of contraindications to CT – MR of chest, abdomen and pelvis) and 68Ga-PSMA PET/CT examination., Castrate testosterone level (testosterone < 50 ng/dl or 1,7 nmol/L), Patients with adequate function of main organs, defined as an adequate reserve of bone marrow and function of liver and kidneys: 1. bone marrow - neutrophils > 1500x109/L; thrombocytes > 100 000x109/L; hemoglobin > 9 g/dL; 2) liver - bilirubin < 2xUNL (upper limit of normal range) and < 5xULN in patients with Gilbert's syndrome; aminotransferase < 3xUNL; 3) kidneys - eGFR > 50 ml/min; albumins > 2.5mg/ml
The presence of distant metastases, proven by radiological examination or PET/CT examination with 68Ga-PSMA., Absence of approval to use effective constraception method., Absence of Patient's consent to participate in the study., Urinary tract obstruction or/and hydronephrosis., Concurrent anticancer treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method