NCT07152067Not yet recruitingPhase 2
Stereotactic Focal Radiotherapy as an Alternative Treatment to Active Surveillance for Low and Intermediate Risk Prostate Cancer
Stereotactic Focal Radiotherapy as an Alternative Treatment to Active Surveillance for Low and Intermediate Risk Prostate Cancer: a Multicentric Phase-II Randomized Trial
Source: ClinicalTrials.gov · Last updated 3 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
\*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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 146 (estimated)
- First submitted
- 12 Aug 2025
- Start date
- Sept 2025
- Primary completion date
- 1 Sept 2030
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Diseases
- Prostate cancer
- NCT number
- NCT07152067
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 146
- From Sept 2025 to the primary completion date, 1 Sept 2030
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Inclusion Criteria (all the criteria must be fulfilled ) :
- a. Localized prostate adenocarcinoma CAPRA score ≤ 5. This lesion is considered the Index lesion
- b. Macroscopic tumor PIRADS score \>4 on multiparametric MRI
- c. The biopsies must be pathologic in or in the direct vicinity (the same prostatic zone defined as a quarter volume of the prostate (PZ)) of the MRI pathologic nodule
- d. The absence of MRI pathologic criteria (PIRADS ≤3) in a Gleason score ≤ 6 (3+3)-ISUP Grade1 zone outside of the single Index lesion is considered clinically non-significant and does not preclude inclusion
- e. The lesion can be plurifocal in a same intent to treat PZ
- f. WHO Performance Status 0-1
- g. No major urinary symptoms with IPSS score ≤15 and urinary continence ICIQ score =0
- h. Patient is candidate for AS
- Exclusion Criteria :
- 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
- 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
Age in the registry: 50 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vivalia Hospitals Coordinator of this site? Confirm its status | Arlon | Belgium | Unknown status |
| University Hospital Liege Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.