Hospital de Terrassa
Terrassa, Barcelona, 08225, Spain
Location status: Recruiting
Location contact
MANUEL GALDEANO
CONTACT
MANUEL GALDEANO
SUB_INVESTIGATOR
SATURIO PAREDES
SUB_INVESTIGATOR
NCT Number: NCT06184464
To determine the possible reduction in prostate size following the administration of Leuprelin prior to the application of radiotherapy.
Interested in participating?
Request Info18 year–95 year
Male
Observational
Terrassa, Barcelona, 08225, Spain
Location status: Recruiting
MANUEL GALDEANO
CONTACT
MANUEL GALDEANO
SUB_INVESTIGATOR
SATURIO PAREDES
SUB_INVESTIGATOR
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.
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.
USE ACETATE LEUPRELINE BEFORE AND AFTER PROSTATE DELIMITATION
Time frame: at 2 months of leupreline
comparative size between pre and post Leupreline treatment
Contact information is provided by the study sponsor or research team.
Consorci Sanitari de Terrassa
Other
Prostatic Size Reduction Following the Administration of Leuprorelin Acetate in Localized Prostate Cancer Prior to Radiation Therapy. Pilot Study.
Acronym: PROSTSIZE
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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