Prostatic Size Reduction Following of Leuprorelin Acetate

Prostate Adenocarcinoma Clinical Trial

— PROSTSIZE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06184464
• Other study ID #: PROSTATE REDUCCION
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostate Cancer Adenocarcinoma
• Prostatic Neoplasms

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