Using radioligand therapy before surgery for prostate cancer with limited metastases
Neoadjuvant [177Lu]Lu-PSMAI&T Radioligand Therapy (PSMA-RLT) for Patients With Oligometastatic Prostate Cancer Diagnosed Using [68Ga]Ga-PSMA-11 PET Imaging Followed by Radical Prostatectomy: A Prospective Phase II Pilot Study
This study is testing if a special type of radiation treatment before surgery can help men with prostate cancer that has spread a little, to see if it improves their health outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Male |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT06259123 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with oligometastatic prostate cancer diagnosed with limited metastases and who are eligible for radical prostatectomy.
Not a fit: Patients with nonmetastatic prostate cancer or those with extensive metastases beyond the study's criteria may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with oligometastatic prostate cancer by enhancing the effectiveness of surgery.
How similar studies have performed: While this approach is innovative, similar studies using radioligand therapy in prostate cancer have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Study coordinator: Sazan Rasul, PhD
- Email: sazan.rasul@meduniwien.ac.at
- Phone: 004314040058742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.