Ignite Creation Date:
2024-05-06 @ 8:28 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02745587
Status:
TERMINATED
Last Update Posted:
2022-12-28
First Post:
2016-04-15
Brief Title:
Evaluating the Impact of Prostate Only Versus Pelvic Radiation for N Prostate Cancer
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
The N-PROPER Trial Evaluating the Impact of Prostate Only Versus Pelvic Radiation for N Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Stopped because of poor accrual in June 2021 after the inclusion of 69 patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROPER
Brief Summary:
At least 40 of the patients with prostate cancer PC present with positive lymph nodes N1 The optimal treatment strategy for these patients remains controversial Although androgen deprivation therapy ADT is still often initiated as only treatment the results are disappointing Recent studies support the use of more aggressive therapies including external beam radiotherapy EBRT and ADT The retrospective studies supporting the additional use of EBRT in N1 PC patients are however not conclusive regarding to the extent of radiation field
Even after an EPLND there might be a role for pelvic EBRT in irradicating microscopic disease However pelvic irradiation irrevocably results in increased toxicity Moreover in node negative N0 PC patients the addition of pelvic EBRT has not resulted in improved outcome in randomised trials However in the setting of Tumor Node Metastasis pathological stage pN1 proven on pathological examination PC patients this has never been evaluated so far This trial aims to answer the question whether or not pelvic EBRT is beneficial in pathological N1 PC patients It is also important to realise that not all pathological N1 PC patients have similar outcome There is a significant impact of number of positive lymph nodes on outcome with two positive nodes being suggested as a significant cut-off value in predicting survival in pathological N1 PC patients By stratifying the patients according to the number of lymph nodes involved this study will add to the proper selection of those patients who will benefit most of pelvic EBRT and avoid toxicity in patients who have no benefit of pelvic EBRT
Additionally small RNAs constitute potentially valuable markers for the diagnosis prognosis and therapeutic choices in PC patients Blood samples will be collected to examine the potential role of miRNAs as a biomarker and to develop a prognostic signature for clinical relapse-free survival
The results of this trial will serve as a base for developping new trials in order to optimise the treatment of patients with pathological N1 PC
Even after an EPLND there might be a role for pelvic EBRT in irradicating microscopic disease However pelvic irradiation irrevocably results in increased toxicity Moreover in node negative N0 PC patients the addition of pelvic EBRT has not resulted in improved outcome in randomised trials However in the setting of Tumor Node Metastasis pathological stage pN1 proven on pathological examination PC patients this has never been evaluated so far This trial aims to answer the question whether or not pelvic EBRT is beneficial in pathological N1 PC patients It is also important to realise that not all pathological N1 PC patients have similar outcome There is a significant impact of number of positive lymph nodes on outcome with two positive nodes being suggested as a significant cut-off value in predicting survival in pathological N1 PC patients By stratifying the patients according to the number of lymph nodes involved this study will add to the proper selection of those patients who will benefit most of pelvic EBRT and avoid toxicity in patients who have no benefit of pelvic EBRT
Additionally small RNAs constitute potentially valuable markers for the diagnosis prognosis and therapeutic choices in PC patients Blood samples will be collected to examine the potential role of miRNAs as a biomarker and to develop a prognostic signature for clinical relapse-free survival
The results of this trial will serve as a base for developping new trials in order to optimise the treatment of patients with pathological N1 PC
Detailed Description:
In an era with increasing evidence in favour of an aggressive local treatment where an extended pelvic lymph node dissection EPLND is more frequently performed and with data supporting the potential role for external beam radiotherapy EBRT in pelvic node positive N1 prostate cancer PC the treatment of N1 PC patients needs to be revised Seen the lack of clear guidelines regarding the extent of radiation field in N1 prostate cancer patients there is an urgent need for studies evaluating the place of pelvic EBRT
The aim of this trial is thus to evaluate if pelvic irradiation has an impact on clinical relapse free survival in pathological N1 PC
The hypothesis is that performing a pelvic EBRT after EPLND in pathological N1 PC patients results in a significant improved clinical relapse free survival with 15 when compared to prostate only EBRT
This will be evaluated in a multicentre Phase III stratified randomised trial randomising patients with PC and 1-4 positive lymph nodes on EPLND between prostatebed only radiotherapy 2 years of ADT or pelvic radiotherapy 2 years of androgen deprivation A total of 330 patients will be enrolled in this trial Stratification is based on the number of positive lymph nodes since patients with increased number of positive lymph nodes exhibit a poorer prognosis
The aim of this trial is thus to evaluate if pelvic irradiation has an impact on clinical relapse free survival in pathological N1 PC
The hypothesis is that performing a pelvic EBRT after EPLND in pathological N1 PC patients results in a significant improved clinical relapse free survival with 15 when compared to prostate only EBRT
This will be evaluated in a multicentre Phase III stratified randomised trial randomising patients with PC and 1-4 positive lymph nodes on EPLND between prostatebed only radiotherapy 2 years of ADT or pelvic radiotherapy 2 years of androgen deprivation A total of 330 patients will be enrolled in this trial Stratification is based on the number of positive lymph nodes since patients with increased number of positive lymph nodes exhibit a poorer prognosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None