Percutaneous Thermo-ablation for the Treatment of Prostate Cancer Oligometastatasis (TA-P-OLIM)

NCT07237399 | Not Yet Recruiting

• 1 other identifier: ONZ-2025-0064
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer (Adenocarcinoma); Ablation Techniques; Oligometastatic Prostate Cancer (OMPC)

Keywords

thermal ablation; prostate cancer; cryoablation

Outcome Measures

Primary Outcomes (1)

• 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.

  Until two years post treatment (thermal ablation)

Secondary Outcomes (9)

• Tolerability of the treatment: proportion of patients without grade ≥3 treatment-related adverse events and without grade 5 adverse events following percutaneous ablative therapy

  until 90 days post treatment

• Technical efficacy (feasibility)

  6 weeks post treatment

• Prostate-Specific Antigen progression-free survival (PSA-PFS)

  Until 2 years post treatment

• PSA50 response

  Until 2 years post treatment

• Time to next-line systemic treatment-free survival (NEST-FS)

  Until 2 years post treatment

Study Arms (1)

Oligometastatic prostate cancer

The TA-P-OLIM Phase II study is a prospective, single-arm clinical trial designed to assess the safety, efficacy, and feasibility of percutaneous thermal ablation in the treatment of oligometastatic prostate cancer in patients who are no longer eligible for or refuse stereotactic body radiation therapy SBRT.

Procedure: Thermal ablation

Interventions

Thermal ablation PROCEDURE

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.

Also known as: cryoablation, RFA, MWA, radiofrequency ablation, microwave ablation, percutaneous thermal ablation

Oligometastatic prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with oligometastatic prostate cancer, characterized by 1-5 metastases who are no longer eligible for or refuse SBRT

You may qualify if:

• \> 18 years old
• PCa, treated with curative intent (radical prostatectomy, primary radiotherapy, or a combination of both) and oligorecurrent/oligopersistent metastasis (1 - 5 lesions) on imaging (PSMA-PET, CT, MRI).
• Recurrence or progression of metastases on imaging (PSMA-PET, CT, MRI) that cannot be treated with SBRT, either due to a history of previous high-dose radiotherapy with dose constraints, because SBRT is technically unfeasible or unsafe for the specific lesions, or because the patient refuses to undergo SBRT.
• PSMA-positive lesion
• Lesions up to 4 cm that are suitable and safe for TA with an anticipated high rate of technical success
• 'Eastern Cooperative Oncology Group' (ECOG) performance status of 2 or less.
• Patients can be androgen sensitive (mHSPC) or castration resistant (mCRPC).
• All patients will be discussed at the Multidisciplinary Tumor Board.

You may not qualify if:

• \<18y
• Severe comorbidity which limits the further life expectancy of the patient to \< 2 years (opinion of the physician) and no malignancies \< 2 years ago except for non-melanoma skin cancer and non-muscle invasive bladder cancer.
• No local radical treatment of the primary tumor was performed.
• Lack of compliance
• Absence of consent of the patient
• Location: intracranial

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Interventions

Transurethral Resection of Prostate; Cryosurgery; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Ablation Techniques; Radiofrequency Therapy; Therapeutics

Central Study Contacts

Laurens Hermie

CONTACT

+32 332 29 36; laurens.hermie@uzgent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: January 2, 2026
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): April 1, 2031
• Last Updated: December 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)