The TA-P-OLIM Study (Percutaneous Thermo-Ablation of Prostate Cancer OligoMetastasis) is a prospective, interventional phase II study designed to evaluate the feasibility, efficacy, and safety of percutaneous thermal ablation (TA) as a metastasis-directed therapy (MDT) for patients with oligometastatic prostate cancer. So far, these metastases have been locally treated with stereotactic body radiation therapy (SBRT) or surgical resection. Percutaneous TA is a minimally invasive technique that locally destroys tumor tissue using either heat (via microwave or radiofrequency ablation) or cold (via cryoablation). This is achieved by inserting specialized needles into the tumor through a small skin incision under image guidance. TA offers a valuable treatment option for patients who are not suitable candidates for SBRT, such as those with prior radiation exposure or metastases located near critical anatomical structures. In many of these cases, ablation remains feasible through the use of adjunctive thermoprotection techniques, where fluid is injected via a needle to gently displace critical structures, thereby creating a safe buffer zone during treatment. Preliminary retrospective evidence shows that TA achieves comparable local tumor control rates to SBRT/resection with minimal complications.7 As a minimally invasive procedure, TA typically requires only a brief hospital stay-often on an outpatient basis-and enables rapid recovery. This makes TA an attractive alternative to surgery, which is associated with greater morbidity, longer recovery times, and limited suitability for some patients. In contrast to SBRT, TA also allows for simultaneous tissue sampling which is completed in a single session. Moreover, it can be safely repeated in the event of local recurrence. The study focuses on patient-centered endpoints such as local control and tolerability, aiming to improve quality of life through personalized, minimally invasive treatment strategies. TA also offers an effective local treatment option for patients who are not eligible for standard treatments such as SBRT. In this way, an alternative to both SBRT and surgery is provided, enabling continued local treatment for patients. Patients are eligible if they have previously received radical treatment for prostate cancer (surgery or radiotherapy, with or without hormonal therapy), subsequently developed a limited number of metastases (1-5), and are no longer candidates for or deny SBRT. UZ Ghent, with its long-standing research expertise in metastasis-directed therapies for oligometastatic prostate cancer, coordinates the study. The project was established in collaboration with various departments within the Urological Multidisciplinary Tumor Board. Several centers in East and West Flanders have already confirmed their willingness to participate in the study.
Study Type
OBSERVATIONAL
Enrollment
50
Percutaneous thermal ablation is a minimally invasive technique that locally destroys tumor tissue using either heat (via microwave or radiofrequency ablation) or cold (via RFA ablation). Cryoablation is the most commonly used modality for this indication. It is generally well tolerated and enables precise treatment, as the ice ball created during the procedure can be continuously monitored using imaging, ensuring accurate tumor coverage while preserving surrounding healthy tissue.
Ghent University Hospital
Ghent, Belgium
Local control rate
Proportion of patients without local progression of all treated lesions (multiple ablation sessions allowed) at 2 years, verified through follow-up imaging (PSMA-PET CT/CT/MRI) in at least 80% of patients.
Time frame: Until two years post treatment (thermal ablation)
Tolerability of the treatment: proportion of patients without grade ≥3 treatment-related adverse events and without grade 5 adverse events following percutaneous ablative therapy
This key secondary endpoint assesses treatment tolerability, defined as the proportion of patients without grade ≥3 treatment related adverse events and no grade 5 adverse events related to percutaneous ablative therapy at 30 and 90 days (according to Common Terminology Criteria for Adverse Events standards version 6)
Time frame: until 90 days post treatment
Technical efficacy (feasibility)
Proportion of patients achieving complete ablation of all treated lesions on imaging 6 weeks post treatment.
Time frame: 6 weeks post treatment
Prostate-Specific Antigen progression-free survival (PSA-PFS)
Time from ablation to biochemical progression using PCWG3 criteria, that is, * if PSA ≥ 2 ng/mL at baseline: increase of ≥ 25% and ≥ 2 ng/mL. * if PSA \< 2 ng/mL at baseline: increase of ≥ 25%.
Time frame: Until 2 years post treatment
PSA50 response
Proportion of patients achieving 50% decline in PSA from baseline at any time post-ablation.
Time frame: Until 2 years post treatment
Time to next-line systemic treatment-free survival (NEST-FS)
Time from ablation to initiation of new systemic treatment (androgen signaling inhibitor, chemotherapy, or other systemic therapy).
Time frame: Until 2 years post treatment
Distant progression-free survival (D-PFS)
Time from ablation to identification of new distant metastasis on PSMA-PET/CT imaging.
Time frame: Until 2 years post treatlent
Progression-free survival (PFS)
Time from ablation to first of the following: PSA progression, local or distant progression on imaging, start of new systemic therapy, death from any cause
Time frame: Until 2 years post treatment
Overall survival (OS)
Time from ablation to death from any cause.
Time frame: Until two years post treatment
Quality of Life assessed by the EORTC Quality of Life Questionnaire - Core 30 (QLQ-C30)
Quality of Life will be measured using the EORTC Quality of Life Questionnaire - Core 30 (QLQ-C30), a validated 30-item tool yielding scores from 0 to 100. For functioning scales and global health/QoL, higher scores indicate better functioning. For symptom scales and single-item symptom measures, higher scores indicate worse symptoms.
Time frame: Until two years post treatment
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