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Completed

NCT Number: NCT03030625

VMAT for Dominant Intraprostatic Lesion

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).

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Number of Participants With Biochemical Failure at 5 Years

    Time frame: 5 years

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

  2. Local Control

    Time frame: 6 and 9 months following radiotherapy

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

  3. Acute and Late Rectal and Urinary Complications

    Time frame: 5 years

    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 outcomes

  1. Number of Participants Free of Biochemical Progression

    Time frame: 5 years

    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.

  2. 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

    Time frame: 5 years

    Assessment of the QoL perceived by the patient in the urinary incontinence, urinary abstraction irritation, bowel function, sexual function and vitality/hormone functions domains

  3. Disease-free Survival (DFS)

    Time frame: 5 years

    Survival free of any event including biochemical failure, local failure, distant metastasis or death

  4. Verification of Safety Margins

    Time frame: 5 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

Sponsors and collaborators

Lead sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Other

Registry information

Official study 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

Acronym: CaP-VMAT-DIL

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Jan 25, 2017
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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