RECRUITINGPhase 2INTERVENTIONAL
177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer
177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High- and Very High-risk Prostate Cancer After Radical Treatment Using Locoregional Teleradiotherapy and Hormone Therapy
About This Trial
Single-center, non-commercial phase 2 clinical trial to evaluate 177Lu-PSMA as a systemic adjuvant treatment in patients with high and very high risk prostate cancer after radical treatment using locoregional teleradiotherapy and hormone therapy
Who May Be Eligible (Plain English)
Who May Qualify:
- Giving a written willing to sign a consent form
- Histopathologically confirmed high or very high risk prostate cancer
- Completion of radical locoregional treatment
- Completion of locoregional treatment within 3 months before inclusion to the study
- You should be able to carry out daily activities with 0 level of ability (ECOG 0) to 2
- Age over 18 years
- Within 28 days before entering the study, there were no signs of cancer dissemination documented in radiological tests
- Castrate testosterone level (testosteron \< 50 ng/dL lub 1,7 nmol/L)
- Patients with adequate function of main organs:
- bone marrow:
- neutrophils \> 1500x10\^9/L;
- thrombocytes \> 100,000x10\^9/L;
- hemoglobin \> 9 g/dL
- liver:
- bilirubin \< 2xULN (upper limit of normal) in patients with Gilbert's syndrome \< 5xULN;
- aminotransferase \< 3xULN
- kidneys:
- eGFR \> 50 ml/min
- albumin \>2.5 mg/ml
- For men of reproductive age: the need to use double barrier contraception
Who Should NOT Join This Trial:
- The presence of distant metastases confirmed by radiological examination
- Absence of approval to use effective contraception method
- Absence of Patient's consent to participate in the Study
- Urinary tract obstruction or/and hydronephrosis.
- Concurrent anticancer treatment.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Giving a written informed consent
* Histopathologically confirmed high or very high risk prostate cancer
* Completion of radical locoregional treatment
* Completion of locoregional treatment within 3 months before inclusion to the study
* ECOG performance status 0 to 2
* Age over 18 years
* Within 28 days before entering the study, there were no signs of cancer dissemination documented in radiological tests
* Castrate testosterone level (testosteron \< 50 ng/dL lub 1,7 nmol/L)
* Patients with adequate function of main organs:
* bone marrow:
* neutrophils \> 1500x10\^9/L;
* thrombocytes \> 100,000x10\^9/L;
* hemoglobin \> 9 g/dL
* liver:
* bilirubin \< 2xULN (upper limit of normal) in patients with Gilbert's syndrome \< 5xULN;
* aminotransferase \< 3xULN
* kidneys:
* eGFR \> 50 ml/min
* albumin \>2.5 mg/ml
* For men of reproductive age: the need to use double barrier contraception
Exclusion Criteria:
* The presence of distant metastases confirmed by radiological examination
* Absence of approval to use effective contraception method
* Absence of Patient's consent to participate in the Study
* Urinary tract obstruction or/and hydronephrosis.
* Concurrent anticancer treatment.
Treatments Being Tested
DRUG
Lutetium (177Lu) vipivotide tetraxetan
The intervention will consist of a single administration of 7,4 GBq of lutetium (177Lu) vipivotide tetraxetan
Locations (1)
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Gliwice, Poland