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PSMA-RLT in Biochemically Recurrent PCa

RecruitingPhase 2Ages 18 Years - 80 YearsMaleMedical University of Vienna
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In plain words

What the trial is, and whether it could suit you

Prospective single-center one-arm phase II study in patients with prostate cancer and confirmed biochemical recurrence (BCR) with PSA of โ‰ฅ 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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patients with biochemical recurrence after radical prostatectomy and radiotherapy with a PSA doubling-time (DT) of โ‰ค 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 โ‰ฅ1.5 x 109 /L, Platelets โ‰ฅ100 x 109 /L and Haemoglobin โ‰ฅ9 g/dL. * Patients must have adequate renal function with eGFR โ‰ฅ 50mL/min/1.73m2 using the Modification of Diet Renal Disease (MDRD) equation and an Albumin level of โ‰ฅ2.5 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.
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What it tests

  • [177Lu]Lu-PSMA I&T
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Where

1 site
Medical University of Vienna
Vienna, Austria
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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