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

Primary Purpose

Prostate Cancer

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
IGRT/VMAT focal therapy boost to DIL
Sponsored by
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, VMAT, Dominant Intraprostatic Lesion, Intensity modulated radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario de la Princesa

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

IGRT/VMAT focal therapy boost to DIL

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants With Biochemical Failure at 5 Years
Biochemical failure determined according to the Phoenix definition (nadir PSA + 2 ng/ml)
Local Control
An image complete response was defined as disappearance of all morphological and functional lesions in mpMRI 6 to 9 months after 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).

Secondary Outcome Measures

Number of Participants Free of Biochemical Progression
Biochemical disease-free survival according to the Phoenix definition (PSA >2 ng/mL above the currently observed PSA nadir. Defined as the time from enrollment to progression of biochemical disease, or death from any cause, or censoring at the date of the last contact.
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
Assessment of the QoL perceived by the patient in the urinary incontinence, urinary abstraction irritation, bowel function, sexual function and vitality/hormone functions domains
Disease-free Survival (DFS)
Survival free of any event including biochemical failure, local failure, distant metastasis or death
Verification of Safety Margins
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

Full Information

First Posted
January 12, 2017
Last Updated
August 1, 2022
Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
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1. Study Identification

Unique Protocol Identification Number
NCT03030625
Brief Title
VMAT for Dominant Intraprostatic Lesion
Acronym
CaP-VMAT-DIL
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 13, 2017 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, VMAT, Dominant Intraprostatic Lesion, Intensity modulated radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IGRT/VMAT focal therapy boost to DIL
Arm Type
Other
Arm Description
Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria
Intervention Type
Radiation
Intervention Name(s)
IGRT/VMAT focal therapy boost to DIL
Intervention Description
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 Measure Information:
Title
Number of Participants With Biochemical Failure at 5 Years
Description
Biochemical failure determined according to the Phoenix definition (nadir PSA + 2 ng/ml)
Time Frame
5 years
Title
Local Control
Description
An image complete response was defined as disappearance of all morphological and functional lesions in mpMRI 6 to 9 months after radiotherapy.
Time Frame
6 and 9 months following radiotherapy
Title
Acute and Late Rectal and Urinary Complications
Description
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).
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Number of Participants Free of Biochemical Progression
Description
Biochemical disease-free survival according to the Phoenix definition (PSA >2 ng/mL above the currently observed PSA nadir. Defined as the time from enrollment to progression of biochemical disease, or death from any cause, or censoring at the date of the last contact.
Time Frame
5 years
Title
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
Description
Assessment of the QoL perceived by the patient in the urinary incontinence, urinary abstraction irritation, bowel function, sexual function and vitality/hormone functions domains
Time Frame
5 years
Title
Disease-free Survival (DFS)
Description
Survival free of any event including biochemical failure, local failure, distant metastasis or death
Time Frame
5 years
Title
Verification of Safety Margins
Description
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
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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) < 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
Facility Information:
Facility Name
Hospital Universitario de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
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VMAT for Dominant Intraprostatic Lesion

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