VMAT for Dominant Intraprostatic Lesion

NCT03030625 | Completed Results

• 1 other identifier: CaP-VMAT-DIL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Prostate Cancer

Keywords

Prostate Cancer; VMAT; Dominant Intraprostatic Lesion; Intensity modulated radiotherapy

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Biochemical Failure at 5 Years

  Biochemical failure determined according to the Phoenix definition (nadir PSA + 2 ng/ml)

  5 years

• Local Control

  An image complete response was defined as disappearance of all morphological and functional lesions in mpMRI 6 to 9 months after radiotherapy.

  6 and 9 months following radiotherapy

• Acute and Late Rectal and Urinary Complications

  Acute and late rectal and urinary complications defined as the number of participants with treatment-related adverse events assessed by Common Terminology Criteria for Adverse Events CTCAE v4.0 and Radiation- Therapy Oncology Group/ European Organization for Research and Treatment of Cancer RTOG/EORTC scales (been 0: no toxicity and 4: most severe toxicity).

  5 years

Secondary Outcomes (4)

• Number of Participants Free of Biochemical Progression

  5 years

• 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

  5 years

• Disease-free Survival (DFS)

  5 years

• Verification of Safety Margins

  5 years

Study Arms (1)

IGRT/VMAT focal therapy boost to DIL

OTHER

Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria

Radiation: IGRT/VMAT focal therapy boost to DIL

Interventions

IGRT/VMAT focal therapy boost to DIL RADIATION

Image-guided/VMAT 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

IGRT/VMAT focal therapy boost to DIL

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) \< 100 ng/ml
• Gleason score 6-10
• Life expectancy \> 5 years
• Patients who accept the radiotherapy treatment
• Patients provided written informed consent before participating in the trial

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: lead

Study Sites (1)

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Related Publications (25)

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MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Almudena Zapatero Laborda
• Organization: Hospital Universitario de La Princesa

almudena.zapatero@salud.madrid.org

+34 915 20 22 00

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 25, 2017
• Study Start: March 13, 2017
• Primary Completion: January 25, 2023
• Study Completion: January 25, 2023
• Last Updated: July 3, 2024
• Results First Posted: May 24, 2023

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)