PSMA-RLT in Biochemically Recurrent PCa
ConditionProstate Cancer Recurrent
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-80
SponsorMedical University of Vienna
About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- [177Lu]Lu-PSMA I&T
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov