Clinical trial · Interventional
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
NCT06449781CI-TRIAL-00085707PSMA-ADJUVOrecruitingPhase 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)
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
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lutetium (177Lu) vipivotide tetraxetan | Drug | Lutetium (177lu) Vipivotide Tetraxetan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- The intervention will consist of a single administration of 177Lu-PSMA with an activity of 7.4 GBq. Participants will also receive standard hormone therapy
- interventionNames
- Drug: Lutetium (177Lu) vipivotide tetraxetan
- type
- NO_INTERVENTION
- label
- Control
- description
- Participants will receive standard hormone therapy
Primary outcomes (1)
- measure
- Treatment effectiveness
- timeFrame
- 2 and 5 years after end of treatment
- description
- Assessment of treatment failure - the assesment of biochemical progression ratio, defined as a rise of PSA by 2 ng/mL or more above the nadir, proven by a consecutive examination performed at least 4 weeks later
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.References
Publications (0)
Data not yet available
No reference posted for this study.