PSMA-RLT in Biochemically Recurrent PCa
Recruiting · NCT06220188 · Interventional (participants receive a specific treatment) · Lead sponsor: Medical University of Vienna
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
Age range
18 Years to 80 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Medical University of Vienna - Vienna, Austria