Stereotactic Focal Radiotherapy as an Alternative Treatment to Active Surveillance for Low and Intermediate Risk Prostate Cancer

Not Applicable

Not yet recruiting

• Conditions: Macroscopic Tumor Visualized at MRI; Tumor Size Allowing Partial Prostate Treatment Volume; CAPRA SCORE ≤5

• Registration Number: NCT07152067
• Lead Sponsor: Centre Hospitalier Universitaire de Liege

Brief 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

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 Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-12
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study Start: 2025-09-01
• Study First Posted: 2025-09-03
• Last Update Posted: 2025-09-03
• Primary Completion: 2030-09-01
• Study Completion: 2033-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 146

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rescue treatment performed or not	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

Secondary Outcome Measures

Name	Time	Method
Clinical disease free survival	5 years	Parameter reporting any local, regional or distant disease recurrence
International Prostate Symptom Score (IPSS)	5 years	The score evaluates the quality of urinary fonction (score: 0-35). Higher score indicates worse outcome.
International Consultation on Incontinence Questionnaire (ICIQ).	5 years	The score evaluates urinary continence (score: 0-21). Higher score indicates worse outcome.
International Index of Erectile Function - 5 item version (IIEF5)	5 years	The index evaluates the quality of sexual founction (index: 5-25). Higher index indicates better function.
Hospital Anxiety and Depression Scale (HADS)	5 years	The scale evaluates anxiety and depression. Anxiety subscore(0-21). Depression subscore (0-21). An higher value indicates worse outcome.

Trial Locations

Locations (2)

Vivalia Hospitals; 🇧🇪 Arlon, Belgium

University Hospital Liège; 🇧🇪 Liège, Belgium