Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05715502
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2022-12-13
Brief Title:
Focal Salvage Brachytherapy Study FocaSaBra
Sponsor:
The Greater Poland Cancer Centre
Organization:
The Greater Poland Cancer Centre
Study Overview
Official Title:
Assessment of the Toxicity of Focal Salvage Brachytherapy of Recurrent Prostate Cancer After Prior Radiotherapy - the Prospective Focal Salvage Brachytherapy Study FocaSaBra
Status:
RECRUITING
Status Verified Date:
2024-01
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:
FocaSaBra
Brief Summary:
The aim of this prospective phase II study is to evaluate the toxicity of salvage partial focal prostate brachytherapy in patients after prior radiotherapy standard teleradiotherapy with without brachytherapy hypofractionated self-reactive HDR LDR brachytherapy with local recurrence on the part of the prostate gland
Detailed Description:
Prostate cancer is the second most common cancer among men in Poland Currently a large number of diagnosed patients undergo radical radiotherapy Despite the high effectiveness of treatment some patients experience failures in the form of regional and or distant metastases most often in the form of isolated local recurrence In patients with suspected local recurrence we can decide on emergency treatment after PET pelvic MRI with an assessment of the prostate gland and after excluding metastases The oncologicalNCCN and urological EUA recommendations allow salvage surgical treatment observation palliative pharmacological castration or treatment using salvage brachytherapy
Salvage surgical treatment is associated with a 30-65 chance of cure in the top cancer centers in the world and the risk of significant toxicity ranges from 17 to 48
Treatment with brachytherapy due to the intra-tissue nature and the short therapeutic range of radiation can deliver a high dose to the treated area despite prior radiotherapy treatment and exhaustion of tolerance doses in critical organs eg rectum andor bladder Treatment of the entire prostate gland gives a chance of disease-free survival for five years in approximately 65 of patients according to the prospective study RTOG 0526 However emergency treatment in this study was associated with a 14 risk of significant post-treatment toxicity requiring medical intervention There are some reports in the literature on brachytherapy involving cancer in the part of the prostate gland focal brachytherapy but they are only retrospective They show significant treatment efficacy and lower toxicity
Salvage surgical treatment is associated with a 30-65 chance of cure in the top cancer centers in the world and the risk of significant toxicity ranges from 17 to 48
Treatment with brachytherapy due to the intra-tissue nature and the short therapeutic range of radiation can deliver a high dose to the treated area despite prior radiotherapy treatment and exhaustion of tolerance doses in critical organs eg rectum andor bladder Treatment of the entire prostate gland gives a chance of disease-free survival for five years in approximately 65 of patients according to the prospective study RTOG 0526 However emergency treatment in this study was associated with a 14 risk of significant post-treatment toxicity requiring medical intervention There are some reports in the literature on brachytherapy involving cancer in the part of the prostate gland focal brachytherapy but they are only retrospective They show significant treatment efficacy and lower toxicity
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