Stereotactic Focal Radiotherapy as an Alternative Treatment to Active Surveillance for Low and In… (NCT07152067) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Stereotactic Focal Radiotherapy as an Alternative Treatment to Active Surveillance for Low and Intermediate Risk Prostate Cancer
Belgium146 participantsStarted 2025-09
Plain-language 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. 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
Who can participate
Age range
50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 leas…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rescue treatment performed or not
Timeframe: 5 years from the enrollment to the last follow up exams