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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-003713-11 | EudraCT Number |
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Prospective single-center one-arm phase II study in patients with prostate cancer and confirmed biochemical recurrence (BCR) with PSA of ≥ 0.2 ng/ml after radical prostatectomy (RP) or PSA > nadir + 2ng/ml after radiotherapy (RT) but not radio-morphological local recurrence after primary therapy with curative intent receive systemic therapy with only 2 cycles of highly standardized (3 GBq in first cycle and 6 GBq in the second cycle) PSMA-RLT at 6-week intervals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biochemical recurrent prostate cancer but not radio-morphological local recurrence | Experimental | Patients with prostate cancer and confirmed biochemical recurrence with PSA of ≥ 0.2 ng/ml after radical prostatectomy or PSA > nadir + 2ng/ml after radiotherapy but not radio-morphological local recurrence after primary therapy with curative intent will receive systemic therapy with [177Lu]Lu-PSMAI&T radioligand therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [177Lu]Lu-PSMA I&T | Drug | 2 cycles (3 GBq in first cycle and 6 GBq in the second cycle) of [177Lu]Lu-PSMAI&T radioligand therapy at 6-week intervals |
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| Measure | Description | Time Frame |
|---|---|---|
| PSA response | in term of PSA decline of ≥ 50% from baseline value | 12 months |
| Emergence of therapy toxicity | in terms of pathological (Grade 3) reduction of values of blood count (hemoglobin decreased <8.0 g/dL; <4.9 mmol/L; <80 g/L; platelet count decreased <50,000 - 25,000/mm3; <50.0 - 25.0 x 10e9 /L and white blood cell decreased <2000 - 1000/mm3; <2.0 - 1.0 x 10e9 /L. ), kidney (creatinine increased > 3.0 x baseline or >3.0 - 6.0 x upper limit of normal (UNL)) and liver functions (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and GGT increased >5.0 - 20.0 x ULN if baseline was normal or >5.0 - 20.0 x baseline if baseline was abnormal; albumin <2 g/dL or <20 g/L; bilirubin increased >3.0 - 10.0 x ULN if baseline was normal or >3.0 - 10.0 x baseline if baseline was abnormal and lactate dehydrogenase increased > ULN.), assessed by Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to PSA value progression | to evaluate progression free survival | 18 months |
| androgen deprivation therapy- and other treatment-free survival | analyze the time until the start of androgen deprivation therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sazan Rasul, PhD | Contact | 004314040058742 | sazan.rasul@meduniwien.ac.at | |
| Shahrokh F. Shariat, Professor | Contact | 004314040026150 | shahrokh.shariat@meduniwien.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Prospective single-center one-arm phase II study
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| 18 months |
| Evaluation of life quality of the treated patients | Using the questionnaires: FACT-P, EORTC QLQ | 18 months |
| Assess time to imaging progression | In terms of appearance of new PSMA-avid lesions and/or size progression of the metastatic lymph nodes evaluated based on response evaluation criteria of solid tumor (RECIST) version 1.1. | 18 months |
| Quantification of circulating free tumor DNA | Quantification of circulating free tumor DNA (ctDNA), enumeration of circulating tumor cells (CTCs) before and following [177Lu]Lu-PSMAI&T-RLT and analyse molecular changes in liquid biopsy markers following [177Lu]Lu-PSMAI&T-RLT. | 18 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |