PSMA-RLT in Biochemically Recurrent PCa
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [177Lu]Lu-PSMA I&T.
- Who it may be relevant to
- Registry conditions: Prostate Cancer Recurrent. Basic parameters: 18 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
[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
Overview
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.
Interventions
- Drug [177Lu]Lu-PSMA I&T
2 cycles (3 GBq in first cycle and 6 GBq in the second cycle) of \[177Lu\]Lu-PSMAI\&T radioligand therapy at 6-week intervals
Primary outcome measures
- PSA response [Time frame: 12 months]
- Emergence of therapy toxicity [Time frame: 12 months]
Secondary outcome measures (5)
- Time to PSA value progression [Time frame: 18 months]
- androgen deprivation therapy- and other treatment-free survival [Time frame: 18 months]
- Evaluation of life quality of the treated patients [Time frame: 18 months]
- Assess time to imaging progression [Time frame: 18 months]
- Quantification of circulating free tumor DNA [Time frame: 18 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Austria · 1 center
- Medical University of Vienna — Vienna
Identifiers
NCT: NCT06220188 · 1938/2022 · 2022-003713-11