Tests lutetium PSMA radioligand therapy in prostate cancer that has returned
Tests a radioactive drug, 177Lu-PSMA I&T, in men with prostate cancer returning after treatment.
Plain-language title generated from the registry record
Registry title: PSMA-RLT in Biochemically Recurrent PCa
Key facts
- Where
- Vienna, AustriaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06220188, who can take part
Where in Austria
- Medical University of ViennaVienna, AustriaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University of Vienna
- Trial code
- NCT06220188
- Record updated
- 13 February 2024
- Original description
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.Read full original descriptionShow less
[177Lu]Lu-PSMAI&T Radioligand Therapy (PSMA-RLT) for Patients With Prostate Cancer and Biochemical But Not Radio-morphological Local Recurrence After Primary Therapy With Curative Intent: A Prospective Phase II Pilot Study
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.
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.