Status:
RECRUITING
PSMA-RLT in Biochemically Recurrent PCa
Lead Sponsor:
Medical University of Vienna
Conditions:
Prostate Cancer Recurrent
Eligibility:
MALE
18-80 years
Phase:
PHASE2
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 + ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06220188
Start Date
January 15 2024
End Date
January 1 2027
Last Update
February 13 2024
Active Locations (1)
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1
Medical University of Vienna
Vienna, Austria, 1090