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NCT Number: NCT06184464

Prostatic Size Reduction Following of Leuprorelin Acetate

To determine the possible reduction in prostate size following the administration of Leuprelin prior to the application of radiotherapy.

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Key information

Age range

18 year–95 year

Sex eligibility

Male

Study type

Observational

Primary location

Hospital de Terrassa

Terrassa, Barcelona, 08225, Spain

Location status: Recruiting

Location contact

MANUEL GALDEANO

CONTACT

[email protected]

619-819-9500

MANUEL GALDEANO

SUB_INVESTIGATOR

SATURIO PAREDES

SUB_INVESTIGATOR

About this study

Prostate cancer (PC) is the most common tumor in men worldwide, including our country, with an incidence of 34,413 cases in 2020 (70.6 per 100,000 inhabitants) . The elevation of Prostate-Specific Antigen (PSA) in blood and/or an abnormality in rectal examination necessitate a prostate biopsy, the diagnostic procedure involving the extraction of a small prostate tissue sample for microscopic analysis and classification of cancer cells according to the Gleason scale (malignancy grade).

Once diagnosed, extension studies (thoraco-abdominal CT, Bone Scintigraphy, PET Choline, etc.) are conducted to rule out metastasis, the spread of tumor cells originating in the prostate, to other organs. The majority of PC cases are diagnosed at localized stages (without distant disease), allowing for local curative treatments such as surgery (Prostatectomy) and radiation therapy (Prostate Radiotherapy).

Hormonal androgen blockade (HAB) combined with radiation therapy improves oncological outcomes for localized PC . Additionally, HAB administered before radiation therapy results in a reduction in prostate gland size . This reduction allows for a decrease in the volume to be irradiated, leading to lower toxicity on surrounding healthy tissues and organs (primarily the bladder and rectum).

This apparent volume reduction is expected two months after initiating HAB, typically coinciding with the simulation CT scan for radiotherapeutic treatment planning. However, there are no studies certifying or quantifying this reduction and its subsequent benefits in PC treatment.

Currently, comparing prostate size pre- and post-HAB is challenging. The first measurement is obtained from ultrasound and/or MRI at the time of diagnosis, while the second measurement (post-HAB) is only taken during radiotherapist oncologist planning CT. This poses two problems: the inadequacy of comparing prostate sizes between different tests, and potential discrepancies in prostate delineation due to variations among different participating radiation oncologists.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Man with Prostate positive biopsy. Able to Ssgned informed consent form. Need of hormonal treatment before start of radiotherapy

Exclusion criteria

Patients With prostate size of less than 20 cc at diagnosis. Patients With Positive lymph nodes or metastatic prostate cancer disease on imaging studies.

Patients with Previous pelvic radiation therapy.

Treatment and study plan

ACETATE LEUPRELINE

Other

USE ACETATE LEUPRELINE BEFORE AND AFTER PROSTATE DELIMITATION

Primary outcomes

  1. prostate size change

    Time frame: at 2 months of leupreline

    comparative size between pre and post Leupreline treatment

Study contacts

Contact information is provided by the study sponsor or research team.

nicolas feltes

CONTACT

[email protected]

619-819-9500

nicolas feltes

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Consorci Sanitari de Terrassa

Other

Registry information

Official study title

Prostatic Size Reduction Following the Administration of Leuprorelin Acetate in Localized Prostate Cancer Prior to Radiation Therapy. Pilot Study.

Acronym: PROSTSIZE

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 28, 2023
Registry last updated
Sep 19, 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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