Oligometastatic Prostate Cancer (OMPC)TA-P-OLIMNCT07237399
Percutaneous Thermo-ablation for the Treatment of Prostate Cancer Oligometastatasis (TA-P-OLIM)
An observational study of Oligometastatic Prostate Cancer (OMPC) and Prostate Cancer (Adenocarcinoma), run by University Hospital, Ghent at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Oligometastatic Prostate Cancer (OMPC), Prostate Cancer (Adenocarcinoma), Ablation Techniques
- What is being tested?
- Thermal ablation
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 10 May 2026to 1 Apr 2031
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with oligometastatic prostate cancer, characterized by 1-5 metastases who are no longer eligible for or refuse SBRT
Who may be able to join
- > 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.
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Thermo-ablation for the Treatment of Prostate Cancer Oligometastatasis (TA-P-OLIM): a Single Arm Phase II Study
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.
Read more
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
- Oligometastatic Prostate Cancer (OMPC), Prostate Cancer (Adenocarcinoma), Ablation Techniques
- Being tested
- Thermal ablation
- Keywords
- thermal ablation, prostate cancer, cryoablation
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal ablationProcedure or surgery
Also called cryoablation, RFA, MWA, radiofrequency ablation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Thermal ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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)
Measured: until 90 days post treatment
Technical efficacy (feasibility)
Proportion of patients achieving complete ablation of all treated lesions on imaging 6 weeks post treatment.
Measured: 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%.
Measured: Until 2 years post treatment
PSA50 response
Proportion of patients achieving 50% decline in PSA from baseline at any time post-ablation.
Measured: 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).
Measured: 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.
Measured: 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
Measured: Until 2 years post treatment
Overall survival (OS)
Time from ablation to death from any cause.
Measured: 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.
Measured: Until two years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start10 May 2026 (estimated)
- Primary completion1 Apr 2031 (estimated)
- Study completion1 Apr 2031 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oligometastatic Prostate Cancer (OMPC)Studies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237399
- Sponsor's protocol ID
- ONZ-2025-0064
- Acronym
- TA-P-OLIM
- Status last verified
- May 2026
- First submitted
- 14 Nov 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Thermo-ablation for the Treatment of Prostate Cancer Oligometastatasis (TA-P-OLIM): a Single Arm Phase II Study
- ClinicalTrials.gov ID
- NCT07237399
- Acronym / sponsor ID
- TA-P-OLIM / ONZ-2025-0064
- Conditions
- Oligometastatic Prostate Cancer (OMPC), Prostate Cancer (Adenocarcinoma), Ablation Techniques
- Keywords
- thermal ablation, prostate cancer, cryoablation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 10 May 2026 (estimated)
- Primary completion
- 1 Apr 2031 (estimated)
- Study completion
- 1 Apr 2031 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oligometastatic prostate cancer | – | Procedure: Thermal ablationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with oligometastatic prostate cancer, characterized by 1-5 metastases who are no longer eligible for or refuse SBRT
Key inclusion criteria (8 listed)
- > 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
Key exclusion criteria (6 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal ablationAlso: cryoablation, RFA, MWA, radiofrequency ablationPercutaneous 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. | Procedure or surgery | Oligometastatic prostate cancer |
Primary outcome
Local control rate
Time frame: Until two years post treatment (thermal ablation)
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.
9 secondary outcomes
Tolerability of the treatment: proportion of patients without grade ≥3 treatment-related adverse events and without grade 5 adverse events following percutaneous ablative therapy
Time frame: until 90 days post treatment
Technical efficacy (feasibility)
Time frame: 6 weeks post treatment
Prostate-Specific Antigen progression-free survival (PSA-PFS)
Time frame: Until 2 years post treatment
PSA50 response
Time frame: Until 2 years post treatment
Time to next-line systemic treatment-free survival (NEST-FS)
Time frame: Until 2 years post treatment
Distant progression-free survival (D-PFS)
Time frame: Until 2 years post treatlent
Progression-free survival (PFS)
Time frame: Until 2 years post treatment
Overall survival (OS)
Time frame: Until two years post treatment
Quality of Life assessed by the EORTC Quality of Life Questionnaire - Core 30 (QLQ-C30)
Time frame: Until two years post treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oligometastatic Prostate Cancer (OMPC) and Prostate Cancer (Adenocarcinoma), run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control rate (time frame: Until two years post treatment (thermal ablation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.