N/A
Completed N=30
VMAT for Dominant Intraprostatic Lesion
Source: ClinicalTrials.gov NCT03030625 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2023
Primary outcomePrimary: Number of Participants With Biochemical Failure at 5 Years — 0; 30 Participants
Summary
The aim of this study was to determine the efficacy and safety of the implementation of a program of " image-guided focal Intensification dose to intraprostatic dominant lesion " in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy in the Department of Radiation Oncology of HUP (Hospital Universitario de La Princesa), within the established dose escalation protocol with intensity modulated image-guided radiotherapy (IMRT / IGRT).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Biochemical Failure at 5 Years |
0; 30 | — |
| PRIMARY Local Control |
30; 0 | — |
| PRIMARY Acute and Late Rectal and Urinary Complications |
28; 2; 0; 0; 11; 13 | — |
| SECONDARY Number of Participants Free of Biochemical Progression |
30 | — |
| SECONDARY Quality of Life (QoL) Assessed by the Expanded Prostate Cancer Index Composite EPIC16 Scale 0-60 (Best to Worst). The Total Score of the Scale is the Summatory of the Domain's Score |
— | — |
| SECONDARY Disease-free Survival (DFS) |
— | — |
| SECONDARY Verification of Safety Margins |
— | — |
Eligibility Criteria
Inclusion Criteria
- Male > 18 years old with histologic diagnostic of prostate adenocarcinoma
- Clinical stage cT2a-T3b N0-1 M0 (AJCC 7 th edition)
- PSA (prostate-specific antigen) 5 years
- Patients who accept the radiotherapy treatment
- Patients provided written informed consent before participating in the trial
Exclusion Criteria
- Transurethral resection of the prostate or prior prostate surgery
- Previous pelvic radiotherapy
- Urethral stenosis with or without prior dilations
- IPSS>15
- Rectal diverticuli or rectal vascular malformations
- Metastatic disease
- Severe psychiatric or medical conditions that could hamper both treatment and follow-up
Data sourced from ClinicalTrials.gov (NCT03030625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.