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Trial record 2 of 4 for:    16648499 [PUBMED-IDS]

VMAT for Dominant Intraprostatic Lesion (CaP-VMAT-DIL)

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ClinicalTrials.gov Identifier: NCT03030625
Recruitment Status : Not yet recruiting
First Posted : January 25, 2017
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

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 within the established dose escalation protocol with intensity modulated image-guided radiotherapy (IMRT / IGRT).

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: IGRT/VMAT focal therapy boost to DIL Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose Intensification With a Focal Boost to Dominant Intraprostatic Lesion Using Volumetric Modulated Arc Therapy /Image Guided Radiotherapy in Patients With Localized Prostate Cancer
Estimated Study Start Date : February 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
IGRT/VMAT focal therapy boost to DIL
Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria
Radiation: IGRT/VMAT focal therapy boost to DIL
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



Primary Outcome Measures :
  1. Biochemical control [ Time Frame: 3 years ]
    Biochemical failure determined according to the Phoenix definition (nadir PSA + 2 ng/ml)

  2. Local control [ Time Frame: 12 months ]
    Local control evaluated by mpMRI at 12 months after radiotherapy and compared to the baseline scans

  3. Acute and late rectal complications [ Time Frame: 3 years ]
    Acute and late rectal complications defined as the number of participants with treatment-related adverse events assessed by CTCAE v4.0 and RTOG/EORTC scales


Secondary Outcome Measures :
  1. Biochemical disease free survival [ Time Frame: 3 years ]
    Biochemical disease-free survival according to the Phoenix definition (PSA >2 ng/mL above the currently observed PSA nadir

  2. Quality of life (QoL) assessed by IPSS scale [ Time Frame: 3 years ]
    Assessment of the QoL perceived by the patient in the urinary domain

  3. Quality of life (QoL) assessed by VEPIC26 scale [ Time Frame: 3 years ]
    Assessment of the QoL perceived by the patient in the urinary, digestive and hormone domains

  4. Disease-free survival (DFS) [ Time Frame: 3 years ]
    Survival free of any event including biochemical failure, local failure, distant metastasis or death

  5. Verification of Safety Margins [ Time Frame: 3 years ]
    Quantification of the systematic and random errors during the preparation and administration of the radiotherapy treatment in 15 patients. Security margins estimation according to Van Herk formula



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 < 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030625


Contacts
Contact: Almudena Zapatero, MD, PhD +3491 520 23 15 almudena.zapatero@salud.madrid.org
Contact: María Roch, MS +3491 520 23 15

Sponsors and Collaborators
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Publications of Results:

Responsible Party: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
ClinicalTrials.gov Identifier: NCT03030625     History of Changes
Other Study ID Numbers: CaP-VMAT-DIL
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa:
Prostate Cancer
VMAT
Dominant Intraprostatic Lesion
Intensity modulated radiotherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases