Status:
NOT_YET_RECRUITING
Stereotactic Focal Radiotherapy as an Alternative Treatment to Active Surveillance for Low and Intermediate Risk Prostate Cancer
Lead Sponsor:
Centre Hospitalier Universitaire de Liege
Conditions:
Macroscopic Tumor Visualized at MRI
Tumor Size Allowing Partial Prostate Treatment Volume
Eligibility:
MALE
50+ years
Phase:
PHASE2
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...
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 fid...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2033
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT07152067
Start Date
September 1 2025
End Date
September 1 2033
Last Update
September 3 2025
Active Locations (2)
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1
Vivalia Hospitals
Arlon, Belgium, 6700
2
University Hospital Liège
Liège, Belgium, 4000