Treatment for recurrent prostate cancer using PSMA radioligand therapy
[177Lu]Lu-PSMAI&T Radioligand Therapy (PSMA-RLT) for Patients With Prostate Cancer and Biochemical But Not Radio-morphological Local Recurrence After Primary Therapy With Curative Intent: A Prospective Phase II Pilot Study
This study is testing a new treatment for men with recurrent prostate cancer to see if a special therapy can help slow down the disease after their PSA levels have risen.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT06220188 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men with biochemical recurrence of prostate cancer after prior radical prostatectomy or radiotherapy, with specific PSA criteria and no local recurrence.
Not a fit: Patients with severe concurrent medical conditions or those participating in other interventional trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with recurrent prostate cancer, potentially improving their outcomes.
How similar studies have performed: Previous studies using PSMA-targeted therapies have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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.