Treatment for recurrent prostate cancer using PSMA radioligand therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial investigates the efficacy of [177Lu]Lu-PSMA I&T in patients with biochemically recurrent prostate cancer who have a PSA level of 0.2 ng/ml or higher after radical prostatectomy or radiotherapy. Participants will receive two cycles of PSMA radioligand therapy at specified intervals, aiming to assess the treatment's impact on disease progression. The study focuses on patients without local recurrence but allows for distant metastases, ensuring a targeted approach to managing recurrent prostate cancer.

Why it matters

Who can join: the full rules

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.

Where it's running

• Medical University of Vienna
  Vienna, Austria Recruiting

Study contacts

• Study coordinator: Sazan Rasul, PhD
• Email: sazan.rasul@meduniwien.ac.at
• Phone: 004314040058742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.