Macroscopic Tumor Visualized at MRIPhase 2TOPPGUN-RSNCT07152067
Stereotactic Focal Radiotherapy as an Alternative Treatment to Active Surveillance for Low and Intermediate Risk Prostate Cancer
A Phase 2 study testing Stereotactic Body Radiation Therapy (SBRT) in people with Macroscopic Tumor Visualized at MRI and Tumor Size Allowing Partial Prostate Treatment Volume, run by Centre Hospitalier Universitaire de Liege at 2 sites in Belgium.
Trial summary
*Rationale : Active surveillance of prostate cancer helps to avoid the morbidity associated with curative radical prostatectomy /radiotherapy in patients with early stage disease. However, at 5 years and 15 years, respectively 35 % and nearly 50 % of patients require rescue interventional treatments. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Macroscopic Tumor Visualized at MRI, Tumor Size Allowing Partial Prostate Treatment Volume, CAPRA SCORE ≤5
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 2 sitesBelgium
- Study dates
- Sep 2025to 1 Sep 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- a. Age at diagnosis < 50 years
- b. Time between initial diagnostic biopsies and randomization > 4 months, or radiation therapy initiation > 6 months
- c. Cribriform or Intraductal histologic components
- d. Gleason Score ≥7 (3+4)-ISUP Grade 2 biopsy outside the intent to treat PZ
- e. Multicentric pathologic MRI (PIRADS ≥4) outside a same PZ
- f. Initial PSA > 20 ng/ml
Show all 13Show fewer
- g. Regional pathologic nodes or metastases
- h. Androgen-deprivation therapy
- i. Any cancer within the last 5 years except skin basocellular carcinoma or any uncontrolled cancer
- j. Urethral stenosis
- k. Recurrent prostatitis (at least 3 episodes within the last 3 years)
- l. Any inflammatory collagen disease.
- m. Contraindication to repeated prostatic biopsies or MRI
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites
Vivalia Hospitals
Arlon, 6700
Annabelle Stainier, MD, +3263551500, annabelle.stainier@gmail.com
Frederic Leduc, MD
University Hospital Liège
Liège, 4000
Mareva Lamande, MD, +3243233903, mareva.lamande@chuliege.be
Sandra Tonneau, Secretary, +3243237596, stonneau@chuliege.be
About this study
Official title: Stereotactic Focal Radiotherapy as an Alternative Treatment to Active Surveillance for Low and Intermediate Risk Prostate Cancer: a Multicentric Phase-II Randomized Trial
*Rationale : Active surveillance of prostate cancer helps to avoid the morbidity associated with curative radical prostatectomy /radiotherapy in patients with early stage disease. However, at 5 years and 15 years, respectively 35 % and nearly 50 % of patients require rescue interventional treatments. Numerous Phase II trials have reported using focal treatments (focused on the macroscopic tumor only while not involving the whole prostatic gland) in order to reduce the morbidity due to recurrence as well as the high anxiety rates under observation only. Stereotactic radiotherapy (highly focused radiotherapy technic to reduce the risk of side effects) is being proposed in the same way as it does not require any anaesthesia, as opposed to all the other focal methods. The purpose of this trial is to evaluate whether focal stereotactic radiotherapy treatments could reduce the rate of rescue treatments among patients eligible to an active surveillance program at first.
- Major Inclusion Criteria :
- 1. Early stage prostate adenocarcinoma (CAPRA score ≤ 5)
- 2. No major urinary problems
- 3. Active Surveillance possible
- Major Exclusion Criteria :
- 1. Age at diagnosis < 50 years
- 8. Androgen-deprivation therapy
- 9. Any cancer within the last 5 years except skin basocellular carcinoma or any uncontrolled cancer
- Trial : Phase II randomized trial comparing Stereotactic Radiation Therapy focused on the macroscopic tumor or Active Surveillance as the control arm.
- Main objective : to compare the rescue treatment rates between the two arms
Read the detailed description
The stereotactic radiation therapy procedure involves at first placement of 3-4 fiducial markers, a planning computed tomography (CT) scan as well as a planning MRI, both fused thereafter based on fiducial markers. The delay between fiducial markers placement and planning CT Scan - MRI must be of at least 10 days. SBRT delivers 36.25 Gy in 5 fractions prescribed on the 80% isodose or higher. The fractions are delivered with a CyberKnife device every other day for 2 weeks. If constraints to organs at risk can be fulfilled with other radiation therapy devices, the latter can be used for treatment as well. Organs-at-risk (rectal wall, bladder wall, bladder neck, urethra, as well as contralateral neurovascular bundles, contralateral external sphincter and contralateral pudendal vessels) are delineated (see constraints used in the first citation). Gross target volume (GTV) is delineated on the MRI while considering the hypointense T2-weighted nodule, the hypointense apparent diffusion coefficient, and the hyperintense perfusion zone. At first, the GTV is expanded by 1cm in all directions to generate the clinical target volume (CTV). The CTV is then cropped to the limits of the prostate. If the volume ratio CTV/Prostate is under 30%, the expansion margin of the GTV is increased progressively within the prostate by 0.1 cm increments so that the CTV achieves at least 30% of the prostate volume. Hence, a maximum of 1.5 cm margin around the GTV is allowed and encouraged. The CTV is then expanded by 3 mm to generate the planning target volume (PTV).
- Conditions
- Macroscopic Tumor Visualized at MRI, Tumor Size Allowing Partial Prostate Treatment Volume, CAPRA SCORE ≤5
- Being tested
- Stereotactic Body Radiation Therapy (SBRT)
- Keywords
- radiosurgery, focal treatment, early prostate cancer, active surveillance, Phase II randomized study, stereotactic radiotherapy, SBRT, quality of life
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
Also called Focal stereotactic radiation treatment
SBRT to the macroscopic prostate tumor component defined at MRI
| Study group | Role | What they receive |
|---|---|---|
| Active Surveillance | No intervention | Active surveillance involving MRI, follow-up biopsies and PET PSMA exams |
| Focal stereotactic radiation treatment | Experimental | Focal radiation treatment followed by MRI, prostate biopsies and PET PSMA follow up exams Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rescue treatment performed or not
Rescue treatment performed due to:
- Recurrence - evolution (including at least one of these criteria) :
1a. Any pathologic overscoring shift on biopsies examination
1b. Any PSA doubling time < 9 months
1c. Any doubling volume of the initial disease at MRI or appearance of a new prostatic lesion PIRADS ≥4
1d. Regional or distant dissemination 2. Patient's personal decision or tumor board decision
Measured: 5 years from the enrollment to the last follow up exams
Secondary outcomes (5)
Clinical disease free survival
Parameter reporting any local, regional or distant disease recurrence
Measured: 5 years
International Prostate Symptom Score (IPSS)
The score evaluates the quality of urinary fonction (score: 0-35). Higher score indicates worse outcome.
Measured: 5 years
International Consultation on Incontinence Questionnaire (ICIQ).
The score evaluates urinary continence (score: 0-21). Higher score indicates worse outcome.
Measured: 5 years
International Index of Erectile Function - 5 item version (IIEF5)
The index evaluates the quality of sexual founction (index: 5-25). Higher index indicates better function.
Measured: 5 years
Hospital Anxiety and Depression Scale (HADS)
The scale evaluates anxiety and depression. Anxiety subscore(0-21). Depression subscore (0-21). An higher value indicates worse outcome.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study startSep 2025 (estimated)
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Macroscopic Tumor Visualized at MRIStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized between active surveillance or stereotactic radiation focused on the Index prostatic lesion visualized at MRI exams
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NICKERS Philippe, Centre Hospitalier Universitaire de Liege
- Investigators
- Philippe Nickers, MD, PhD, Principal investigator, University Hospital Liège, BelgiumMareva Lamande, MD, Principal investigator, University Hospital Liège, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152067
- Sponsor's protocol ID
- 2025/176
- Other IDs
- B7072025000023
- Acronym
- TOPPGUN-RS
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Forbidden according EU regulations. If Wished by researchers, they will have first to obtain the consent of the patients
Publications
Nguyen PV, Donneaux B, Louis C, Bodgal Z, Philippi S, Biver S, Frederick B, Harze L, Lasar Y, Vogin G, Nickers P. Stereotactic focal radiotherapy as an alternative treatment for low-risk prostate cancer: Results of a single-arm monocenter Phase-II trial. Front Oncol. 2023 Apr 6;13:1143716. doi: 10.3389/fonc.2023.1143716. eCollection 2023.
PubMed 37091187Newcomb LF, Schenk JM, Zheng Y, Liu M, Zhu K, Brooks JD, Carroll PR, Dash A, de la Calle CM, Ellis WJ, Filson CP, Gleave ME, Liss MA, Martin F, McKenney JK, Morgan TM, Tretiakova MS, Wagner AA, Nelson PS, Lin DW. Long-Term Outcomes in Patients Using Protocol-Directed Active Surveillance for Prostate Cancer. JAMA. 2024 Jun 25;331(24):2084-2093. doi: 10.1001/jama.2024.6695.
PubMed 38814624Hopstaken JS, Bomers JGR, Sedelaar MJP, Valerio M, Futterer JJ, Rovers MM. An Updated Systematic Review on Focal Therapy in Localized Prostate Cancer: What Has Changed over the Past 5 Years? Eur Urol. 2022 Jan;81(1):5-33. doi: 10.1016/j.eururo.2021.08.005. Epub 2021 Sep 4.
PubMed 34489140Hamdy FC, Donovan JL, Lane JA, Metcalfe C, Davis M, Turner EL, Martin RM, Young GJ, Walsh EI, Bryant RJ, Bollina P, Doble A, Doherty A, Gillatt D, Gnanapragasam V, Hughes O, Kockelbergh R, Kynaston H, Paul A, Paez E, Powell P, Rosario DJ, Rowe E, Mason M, Catto JWF, Peters TJ, Oxley J, Williams NJ, Staffurth J, Neal DE; ProtecT Study Group. Fifteen-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med. 2023 Apr 27;388(17):1547-1558. doi: 10.1056/NEJMoa2214122. Epub 2023 Mar 11.
PubMed 36912538
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Focal Radiotherapy as an Alternative Treatment to Active Surveillance for Low and Intermediate Risk Prostate Cancer: a Multicentric Phase-II Randomized Trial
- ClinicalTrials.gov ID
- NCT07152067
- Acronym / sponsor ID
- TOPPGUN-RS / 2025/176
- Conditions
- Macroscopic Tumor Visualized at MRI, Tumor Size Allowing Partial Prostate Treatment Volume, CAPRA SCORE ≤5
- Keywords
- radiosurgery, focal treatment, early prostate cancer, active surveillance, Phase II randomized study, stereotactic radiotherapy, SBRT, quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de LiegeUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2033 (estimated)
- First posted
- 3 Sep 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.
*Rationale : Active surveillance of prostate cancer helps to avoid the morbidity associated with curative radical prostatectomy /radiotherapy in patients with early stage disease. However, at 5 years and 15 years, respectively 35 % and nearly 50 % of patients require rescue interventional treatments. Numerous Phase II trials have reported using focal treatments (focused on the macroscopic tumor only while not involving the whole prostatic gland) in order to reduce the morbidity due to recurrence as well as the high anxiety rates under observation only. Stereotactic radiotherapy (highly focused radiotherapy technic to reduce the risk of side effects) is being proposed in the same way as it does not require any anaesthesia, as opposed to all the other focal methods. The purpose of this trial is to evaluate whether focal stereotactic radiotherapy treatments could reduce the rate of rescue treatments among patients eligible to an active surveillance program at first.
- Major Inclusion Criteria :
- 1. Early stage prostate adenocarcinoma (CAPRA score ≤ 5)
- 2. No major urinary problems
- 3. Active Surveillance possible
- Major Exclusion Criteria :
- 1. Age at diagnosis < 50 years
- 8. Androgen-deprivation therapy
- 9. Any cancer within the last 5 years except skin basocellular carcinoma or any uncontrolled cancer
- Trial : Phase II randomized trial comparing Stereotactic Radiation Therapy focused on the macroscopic tumor or Active Surveillance as the control arm.
- Main objective : to compare the rescue treatment rates between the two arms
Detailed description
The stereotactic radiation therapy procedure involves at first placement of 3-4 fiducial markers, a planning computed tomography (CT) scan as well as a planning MRI, both fused thereafter based on fiducial markers. The delay between fiducial markers placement and planning CT Scan - MRI must be of at least 10 days. SBRT delivers 36.25 Gy in 5 fractions prescribed on the 80% isodose or higher. The fractions are delivered with a CyberKnife device every other day for 2 weeks. If constraints to organs at risk can be fulfilled with other radiation therapy devices, the latter can be used for treatment as well. Organs-at-risk (rectal wall, bladder wall, bladder neck, urethra, as well as contralateral neurovascular bundles, contralateral external sphincter and contralateral pudendal vessels) are delineated (see constraints used in the first citation). Gross target volume (GTV) is delineated on the MRI while considering the hypointense T2-weighted nodule, the hypointense apparent diffusion coefficient, and the hyperintense perfusion zone. At first, the GTV is expanded by 1cm in all directions to generate the clinical target volume (CTV). The CTV is then cropped to the limits of the prostate. If the volume ratio CTV/Prostate is under 30%, the expansion margin of the GTV is increased progressively within the prostate by 0.1 cm increments so that the CTV achieves at least 30% of the prostate volume. Hence, a maximum of 1.5 cm margin around the GTV is allowed and encouraged. The CTV is then expanded by 3 mm to generate the planning target volume (PTV).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized between active surveillance or stereotactic radiation focused on the Index prostatic lesion visualized at MRI exams
| Arm | Type | Receives |
|---|---|---|
| Active Surveillance | No intervention | –Active surveillance involving MRI, follow-up biopsies and PET PSMA exams |
| Focal stereotactic radiation treatment | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT)Focal radiation treatment followed by MRI, prostate biopsies and PET PSMA follow up exams |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
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 |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT)Also: Focal stereotactic radiation treatmentSBRT to the macroscopic prostate tumor component defined at MRI | Radiation | Focal stereotactic radiation treatment |
Primary outcome
Rescue treatment performed or not
Time frame: 5 years from the enrollment to the last follow up exams
Rescue treatment performed due to: 1. Recurrence - evolution (including at least one of these criteria) : 1a. Any pathologic overscoring shift on biopsies examination 1b. Any PSA doubling time < 9 months 1c. Any doubling volume of the initial disease at MRI or appearance of a new prostatic lesion PIRADS ≥4 1d. Regional or distant dissemination 2. Patient's personal decision or tumor board decision
5 secondary outcomes
Clinical disease free survival
Time frame: 5 years
International Prostate Symptom Score (IPSS)
Time frame: 5 years
International Consultation on Incontinence Questionnaire (ICIQ).
Time frame: 5 years
International Index of Erectile Function - 5 item version (IIEF5)
Time frame: 5 years
Hospital Anxiety and Depression Scale (HADS)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Background: PubMed 37091187Nguyen PV, Donneaux B, Louis C, Bodgal Z, Philippi S, Biver S, Frederick B, Harze L, Lasar Y, Vogin G, Nickers P. Stereotactic focal radiotherapy as an alternative treatment for low-risk prostate cancer: Results of a single-arm monocenter Phase-II trial. Front Oncol. 2023 Apr 6;13:1143716. doi: 10.3389/fonc.2023.1143716. eCollection 2023.
- Background: PubMed 38814624Newcomb LF, Schenk JM, Zheng Y, Liu M, Zhu K, Brooks JD, Carroll PR, Dash A, de la Calle CM, Ellis WJ, Filson CP, Gleave ME, Liss MA, Martin F, McKenney JK, Morgan TM, Tretiakova MS, Wagner AA, Nelson PS, Lin DW. Long-Term Outcomes in Patients Using Protocol-Directed Active Surveillance for Prostate Cancer. JAMA. 2024 Jun 25;331(24):2084-2093. doi: 10.1001/jama.2024.6695.
- Background: PubMed 34489140Hopstaken JS, Bomers JGR, Sedelaar MJP, Valerio M, Futterer JJ, Rovers MM. An Updated Systematic Review on Focal Therapy in Localized Prostate Cancer: What Has Changed over the Past 5 Years? Eur Urol. 2022 Jan;81(1):5-33. doi: 10.1016/j.eururo.2021.08.005. Epub 2021 Sep 4.
- Background: PubMed 36912538Hamdy FC, Donovan JL, Lane JA, Metcalfe C, Davis M, Turner EL, Martin RM, Young GJ, Walsh EI, Bryant RJ, Bollina P, Doble A, Doherty A, Gillatt D, Gnanapragasam V, Hughes O, Kockelbergh R, Kynaston H, Paul A, Paez E, Powell P, Rosario DJ, Rowe E, Mason M, Catto JWF, Peters TJ, Oxley J, Williams NJ, Staffurth J, Neal DE; ProtecT Study Group. Fifteen-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med. 2023 Apr 27;388(17):1547-1558. doi: 10.1056/NEJMoa2214122. Epub 2023 Mar 11.
- Individual participant dataSharing planned: No. Forbidden according EU regulations. If Wished by researchers, they will have first to obtain the consent of the patients
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.
Philippe Nickers, MD, PhD principal investigator
University Hospital Liège, Belgium
Mareva Lamande, MD principal investigator
University Hospital Liège, Belgium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Body Radiation Therapy (SBRT) in people with Macroscopic Tumor Visualized at MRI and Tumor Size Allowing Partial Prostate Treatment Volume, run by Centre Hospitalier Universitaire de Liege at 2 sites 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 0 inclusion and 13 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: opening soon, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mareva Lamande, MD (+3243233903, mareva.lamande@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rescue treatment performed or not (time frame: 5 years from the enrollment to the last follow up exams). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07152067, which also lists 4 linked publications.
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 3 Sep 2025.