Using 177Lu-PSMA to treat high-risk prostate cancer after radical treatment
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
This study is testing if a new treatment called 177Lu-PSMA can help men with high-risk prostate cancer stay cancer-free after their initial treatment and hormone therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Maria Sklodowska-Curie National Research Institute of Oncology Academic / other |
| Locations | 1 site (Gliwice) |
| Trial ID | NCT06449781 on ClinicalTrials.gov |
What this trial studies
This phase 2 clinical trial evaluates the effectiveness of 177Lu-PSMA as a systemic adjuvant treatment for adult men with high and very high-risk prostate cancer following radical locoregional treatment and hormone therapy. Participants will receive a single administration of 177Lu-PSMA, while both the study and control groups will continue standard hormone therapy. The study aims to assess the safety and efficacy of this intervention over a five-year observation period, focusing on patients who show no signs of cancer dissemination after their initial treatment.
Who should consider this trial
Good fit: Ideal candidates are adult men over 18 years with histopathologically confirmed high or very high-risk prostate cancer who have completed radical locoregional treatment within the last three months.
Not a fit: Patients with signs of cancer dissemination or those who do not meet the specified health criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with high-risk prostate cancer by reducing the risk of cancer recurrence.
How similar studies have performed: Other studies have shown promise with similar approaches using targeted radioligand therapy in prostate cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Gliwice
- Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch — Gliwice, Poland (Recruiting)
Study contacts
- Study coordinator: Daria Handkiewicz-Junak
- Email: daria.handkiewicz-junak@gliwice.nio.gov.pl
- Phone: 48322789339
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.