CompletedNot Applicable

VMAT for Dominant Intraprostatic Lesion

Spain30 participantsStarted 2017-03-13

Plain-language 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).

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Biochemical Failure at 5 Years

Timeframe: 5 years

Local Control

Timeframe: 6 and 9 months following radiotherapy

Acute and Late Rectal and Urinary Complications

Timeframe: 5 years

Trial details

NCT IDNCT03030625

SponsorFundación de Investigación Biomédica - Hospital Universitario de La Princesa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-25

Results submitted2021-08-04

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