N/A N=30 Treatment

VMAT for Dominant Intraprostatic Lesion

Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT03030625 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2023

Primary outcome: Primary: Number of Participants With Biochemical Failure at 5 Years — 0; 30 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: IGRT/VMAT focal therapy boost to DIL (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Primary completion: Jan 2023

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	—	—

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).

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

View full record on ClinicalTrials.gov →

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.