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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06184464
Other study ID # PROSTATE REDUCCION
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 2, 2024
Est. completion date December 15, 2024

Study information

Verified date May 2024
Source Consorci Sanitari de Terrassa
Contact nicolas feltes
Phone 619-819-9500
Email nicofeltes_81@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 15, 2024
Est. primary completion date July 15, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 95 Years
Eligibility 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.

Study Design


Intervention

Other:
ACETATE LEUPRELINE
USE ACETATE LEUPRELINE BEFORE AND AFTER PROSTATE DELIMITATION

Locations

Country Name City State
Spain Hospital de Terrassa Terrassa Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Consorci Sanitari de Terrassa

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary prostate size change comparative size between pre and post Leupreline treatment at 2 months of leupreline
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