PSMA-RLT in Biochemically Recurrent PCa

Medical University of Vienna

Status and phase: Enrolling; Phase 2

Conditions: Prostate Cancer Recurrent

Treatments: Drug: [177Lu]Lu-PSMA I&T

Study type: Interventional

Funder types: Other

Identifiers

NCT06220188

1938/2022

2022-003713-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Biochemical recurrent prostate cancer but not radio-morphological local recurrence

Experimental group

Description:

Patients with prostate cancer and confirmed biochemical recurrence with PSA of ≥ 0.2 ng/ml after radical prostatectomy or PSA \> nadir + 2ng/ml after radiotherapy but not radio-morphological local recurrence after primary therapy with curative intent will receive systemic therapy with \[177Lu\]Lu-PSMAI\&T radioligand therapy

Treatment:

Drug: [177Lu]Lu-PSMA I&T