PSMA-RLT in Biochemically Recurrent PCa

Last updated: February 10, 2024
Sponsor: Medical University of Vienna
Overall Status: Active - Recruiting

Phase

2

Condition

Prostate Disorders

Urologic Cancer

Prostate Cancer

Treatment

[177Lu]Lu-PSMA I&T

Clinical Study ID

NCT06220188
1938/2022
2022-003713-11
  • Ages 18-80
  • Male

Study Summary

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

Inclusion

Inclusion Criteria:

  • Patients with biochemical recurrence after radical prostatectomy and radiotherapy witha 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 isallowed: (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 theModification 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

Exclusion Criteria:

  • Concomitant participation in any other interventional trial.
  • Concurrent severe oncological and medical conditions that result in patients nothaving a life expectancy of longer than one year.
  • Presence of clinically relevant somatic or psychiatric diseases that might interferewith the objectives and assessments of the study.
  • Complete urinary out-flow obstruction or severe unmanageable urinary incontinence.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: [177Lu]Lu-PSMA I&T
Phase: 2
Study Start date:
January 15, 2024
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • Medical University of Vienna

    Vienna, 1090
    Austria

    Active - Recruiting

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