PSMA-RLT in Biochemically Recurrent PCa
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 r
| Condition(s) | Prostate Cancer Recurrent |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 i |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Lead sponsor | Medical University of Vienna |
| Locations | Vienna, Austria |
| Start date | 2024-01-15 |
| NCT ID | NCT06220188 |
| Official listing | https://clinicaltrials.gov/study/NCT06220188 |