Using radioligand therapy before surgery for prostate cancer with limited metastases

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 evaluates the effectiveness of systemic radioligand therapy using [177Lu]Lu-PSMAI&T in patients with oligometastatic prostate cancer who are scheduled for radical prostatectomy. The study aims to assess the response in terms of prostate-specific antigen (PSA) levels, imaging results, and pathological outcomes. A total of ten patients diagnosed with oligometastatic prostate cancer via [68Ga]Ga-PSMA-11 PET imaging will be included to determine the therapy's impact on oncological outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Oligometastatic PCa diagnosed using \[68Ga\]Ga-PSMA-11 imaging defined as M1a and/or M1b positive with ≤5 osseous metastases and/or M1c ≤3 lung metastases
* 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 oncologic and medical conditions that result in patients not having a life expectancy of longer than the duration of the trial.
* Nonmetastatic PCa on \[68Ga\]Ga-PSMA-11 imaging
* \>5 osseous metastases on \[68Ga\]Ga-PSMA-11 imaging
* Visceral metastases, apart from lungs
* Age \> 75 years.
* Ongoing or previous androgen deprivation therapy with agonist or antagonist therapies.
* 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.