Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06184464
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-12-05
Brief Title:
Prostatic Size Reduction Following of Leuprorelin Acetate
Sponsor:
Consorci Sanitari de Terrassa
Organization:
Consorci Sanitari de Terrassa
Study Overview
Official Title:
Prostatic Size Reduction Following the Administration of Leuprorelin Acetate in Localized Prostate Cancer Prior to Radiation Therapy Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROSTSIZE
Brief Summary:
To determine the possible reduction in prostate size following the administration of Leuprelin prior to the application of radiotherapy
Detailed Description:
Prostate cancer PC is the most common tumor in men worldwide including our country with an incidence of 34413 cases in 2020 706 per 100000 inhabitants The elevation of Prostate-Specific Antigen PSA in blood andor 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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None