Prostate Cancer Recurrent
Conditions
Keywords
[177Lu]Lu-PSMA I&T, PSMA-radioligand therapy, Biochemical recurrence, Prostate cancer, PSA value
Brief summary
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.
Interventions
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
Sponsors
Medical University of Vienna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective single-center one-arm phase II study
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with biochemical recurrence after radical prostatectomy and radiotherapy with a PSA doubling-time (DT) of ≤ 12 months. * No hormonal therapy within the last 12 months or recovered testosterone levels. * PSMA PET negative result for local recurrence; presence of distant metastases is allowed: (cN0, cM0/cM1). * Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1 * Patients must have adequate bone marrow reserve: WBC ≥1.5 x 109 /L, Platelets ≥100 x 109 /L and Haemoglobin ≥9 g/dL. * Patients must have adequate renal function with eGFR ≥ 50mL/min/1.73m2 using the Modification of Diet Renal Disease (MDRD) equation and an Albumin level of ≥2.5 g/dL. * Patients must be able to sign Informed Consent Form.
Exclusion criteria
* Concomitant participation in any other interventional trial. * Concurrent severe oncological and medical conditions that result in patients not having a life expectancy of longer than one year. * Presence of clinically relevant somatic or psychiatric diseases that might interfere with the objectives and assessments of the study. * Complete urinary out-flow obstruction or severe unmanageable urinary incontinence.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSA response | 12 months | in term of PSA decline of ≥ 50% from baseline value |
| Emergence of therapy toxicity | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of life quality of the treated patients | 18 months | Using the questionnaires: FACT-P, EORTC QLQ |
| Time to PSA value progression | 18 months | to evaluate progression free survival |
| Quantification of circulating free tumor DNA | 18 months | 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. |
| Assess time to imaging progression | 18 months | 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. |
| androgen deprivation therapy- and other treatment-free survival | 18 months | analyze the time until the start of androgen deprivation therapy |
Countries
Austria
Contacts
Primary ContactSazan Rasul, PhD
Backup ContactShahrokh F. Shariat, Professor
Outcome results
None listed