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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • [177Lu]Lu-PSMA I&T

    Drug

    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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Biochemical recurrent prostate cancer but not radio-morphological local recurrenceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PSA response

in term of PSA decline of ≥ 50% from baseline value

Time frame
12 months
2

Emergence of therapy toxicity

in terms of pathological (Grade 3) reduction of values of blood count (hemoglobin decreased \<8.0 g/dL; \<4.9 mmol/L; \<80 g/L; platelet count decreased \<50,000 - 25,000/mm3; \<50.0 - 25.0 x 10e9 /L and white blood cell decreased \<2000 - 1000/mm3; \<2.0 - 1.0 x 10e9 /L. ), kidney (creatinine increased \> 3.0 x baseline or \>3.0 - 6.0 x upper limit of normal (UNL)) and liver functions (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and GGT increased \>5.0 - 20.0 x ULN if baseline was normal or \>5.0 - 20.0 x baseline if baseline was abnormal; albumin \<2 g/dL or \<20 g/L; bilirubin increased \>3.0 - 10.0 x ULN if baseline was normal or \>3.0 - 10.0 x baseline if baseline was abnormal and lactate dehydrogenase increased \> ULN.), assessed by Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

Time frame
12 months

Secondary outcomes

1

Time to PSA value progression

to evaluate progression free survival

Time frame
18 months
2

androgen deprivation therapy- and other treatment-free survival

analyze the time until the start of androgen deprivation therapy

Time frame
18 months
3

Evaluation of life quality of the treated patients

Using the questionnaires: FACT-P, EORTC QLQ

Time frame
18 months
4

Assess time to imaging progression

In terms of appearance of new PSMA-avid lesions and/or size progression of the metastatic lymph nodes evaluated based on response evaluation criteria of solid tumor (RECIST) version 1.1.

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Vienna

Lead sponsor

Source ClinicalTrials.gov
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