NCT06220188 PSMA-RLT in Biochemically Recurrent PCa
| NCT ID | NCT06220188 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Medical University of Vienna |
| Condition | Prostate Cancer Recurrent |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2024-01-15 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06220188 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 80 Years, studying Prostate Cancer Recurrent. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06220188 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06220188 currently recruiting?
Yes, NCT06220188 is actively recruiting participants. Contact the research team at sazan.rasul@meduniwien.ac.at for enrollment information.
Where is the NCT06220188 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT06220188 clinical trial?
NCT06220188 is sponsored by Medical University of Vienna. The trial plans to enroll 20 participants.
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