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

NCT07152067 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2025-09-03

No results posted yet for this study

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

Conditions

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

Interventions

RADIATION

Stereotactic Body Radiation Therapy (SBRT)

SBRT to the macroscopic prostate tumor component defined at MRI

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Liege

    lead OTHER

Principal Investigators

  • Philippe Nickers, MD, PhD · University Hospital Liège, Belgium

  • Mareva Lamande, MD · University Hospital Liège, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2030-09-01
Completion
2033-09-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07152067 on ClinicalTrials.gov