Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565585
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Prediction of Local Recurrence and Its Impact on Long-term Outcomes After Low-risk Glans-sparing Surgery for Penile Squamous Cell Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prediction of Local Recurrence and Its Impact on Long-term Outcomes After Low-risk Glans-sparing Surgery Defined as Wide Local Excision Circumcision Laser Ablation Glans Resurfacing and Partial Glansectomy for Penile Squamous Cell Carcinoma
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The treatment paradigm for primary penile squamous cell carcinoma PSCC has increasingly favored maximal organ preservation without compromising oncological outcomes However the literature has often included heterogeneous patient cohorts and varied surgical approaches making it challenging to draw definitive conclusions about the impact of local recurrence LR on survival
Since the investigators recently published the results from a large multicentric international study on a homogeneous cohort of high-risk PSCC patients who were treated with upfront complete glansectomy the investigators have been demonstrating that local recurrence after upfront glansectomy was strongly correlated with worse overall survival and cancer-specific survival in this more homogeneous cohort therefore challenging the dogma that LR following organ-sparing surgery for PSCC does not affect survival outcomes Roussel et al BJU Int 2021 DOI 101111bju15297
The investigators hypothesized that these findings were caused by an enrichment of higher risk tumors in this cohort since solely glansectomy patients with a complete removal of all the glandulopreputhial epithelium were included Consequently the hypothesis has arisen that LR might not be a predictor of poorer survival outcomes in lower-risk tumors who underwent glans-sparing surgery defined as circumcision wide local excision laser ablation glans resurfacing and partial glansectomy and that previous findings influencing the guidelines may be heavily influenced by the inclusion of large proportions of low-risk tumors in rather heterogenous cohorts in terms of technical approach
Therefore this study aims to explore whether LR similarly affects survival in lower-risk tumors treated with glans-sparing techniques such as circumcision wide local excision glans resurfacing laser ablation and partial glansectomy
Since the investigators recently published the results from a large multicentric international study on a homogeneous cohort of high-risk PSCC patients who were treated with upfront complete glansectomy the investigators have been demonstrating that local recurrence after upfront glansectomy was strongly correlated with worse overall survival and cancer-specific survival in this more homogeneous cohort therefore challenging the dogma that LR following organ-sparing surgery for PSCC does not affect survival outcomes Roussel et al BJU Int 2021 DOI 101111bju15297
The investigators hypothesized that these findings were caused by an enrichment of higher risk tumors in this cohort since solely glansectomy patients with a complete removal of all the glandulopreputhial epithelium were included Consequently the hypothesis has arisen that LR might not be a predictor of poorer survival outcomes in lower-risk tumors who underwent glans-sparing surgery defined as circumcision wide local excision laser ablation glans resurfacing and partial glansectomy and that previous findings influencing the guidelines may be heavily influenced by the inclusion of large proportions of low-risk tumors in rather heterogenous cohorts in terms of technical approach
Therefore this study aims to explore whether LR similarly affects survival in lower-risk tumors treated with glans-sparing techniques such as circumcision wide local excision glans resurfacing laser ablation and partial glansectomy
Detailed Description:
Penile squamous cell carcinoma PSCC is a rare disease with a limited body of evidence on which to base management decisions The World Health Organization WHO has estimated 36068 new cases of penile cancer in 2020 with an age-standardized incidence of 08 per 100000 people worldwide Traditionally performed partial or total penectomy have been associated with significant comorbidity with respect to altered voiding sexual function appearance and psychological well-being
In terms of treatment of the primary the European Association of Urology EAU guidelines recommend performing complete tumor removal with as much organ preservation as possible without compromising oncological control Organ-sparing surgery OSS encompasses a plethora of surgical techniques including wide local excision circumcision glans resurfacing and partial or total glansectomy
Consequently penile-sparing approaches have been increasingly employed with excellent functional outcomes and significant improvements in patients quality of life compared to radical treatment This trend towards OSS is based on the fact that although patients treated with penile preservation experience more local recurrence LR compared to partial or total penectomy the occurrence of LR did not compromise survival in several previously studied cohorts with a heterogeneous patient population including both high-risk and low-risk tumors
However the investigators recently published the results from a large multicentric international study on a homogeneous cohort of high-risk patients who were treated with upfront complete glansectomy It was found that LR after upfront glansectomy represents an underlying aggressive disease course and was strongly correlated with worse overall survival HR 289 95 CI 202-414 0001 and cancer-specific survival HR 564 95 CI 345-922 P 0001 in this cohort therefore challenging the dogma that LR following OSS for PSCC does not affect survival outcomes Multivariable Cox proportional hazards regression analysis identified pT3 stage and high-grade disease as independent predictors of LR
The investigators hypothesized that these findings were caused by an enrichment of higher risk tumors in our cohort since solely glansectomy patients who undergo a complete removal of all the glandulopreputhial epithelium were studied Conversely the investigators would hypothesize that LR might not be a predictor of poorer survival outcomes in lower risk tumors who undergo wide local excision partial glansectomy laser ablation circumcision or glans resurfacing This would be the reason that previous heterogenous cohorts including these techniques did not find an adverse effect of LR on survival outcomes
Therefore the aim of this study is to study predictive pathological factors for LR as well as the impact of LR on long-term survival outcomes solely in patients who are treated with wide local excision partial glansectomy laser ablation circumcision and glans resurfacing reflecting a lower risk OSS patient population defined as glans-sparing surgery
In terms of treatment of the primary the European Association of Urology EAU guidelines recommend performing complete tumor removal with as much organ preservation as possible without compromising oncological control Organ-sparing surgery OSS encompasses a plethora of surgical techniques including wide local excision circumcision glans resurfacing and partial or total glansectomy
Consequently penile-sparing approaches have been increasingly employed with excellent functional outcomes and significant improvements in patients quality of life compared to radical treatment This trend towards OSS is based on the fact that although patients treated with penile preservation experience more local recurrence LR compared to partial or total penectomy the occurrence of LR did not compromise survival in several previously studied cohorts with a heterogeneous patient population including both high-risk and low-risk tumors
However the investigators recently published the results from a large multicentric international study on a homogeneous cohort of high-risk patients who were treated with upfront complete glansectomy It was found that LR after upfront glansectomy represents an underlying aggressive disease course and was strongly correlated with worse overall survival HR 289 95 CI 202-414 0001 and cancer-specific survival HR 564 95 CI 345-922 P 0001 in this cohort therefore challenging the dogma that LR following OSS for PSCC does not affect survival outcomes Multivariable Cox proportional hazards regression analysis identified pT3 stage and high-grade disease as independent predictors of LR
The investigators hypothesized that these findings were caused by an enrichment of higher risk tumors in our cohort since solely glansectomy patients who undergo a complete removal of all the glandulopreputhial epithelium were studied Conversely the investigators would hypothesize that LR might not be a predictor of poorer survival outcomes in lower risk tumors who undergo wide local excision partial glansectomy laser ablation circumcision or glans resurfacing This would be the reason that previous heterogenous cohorts including these techniques did not find an adverse effect of LR on survival outcomes
Therefore the aim of this study is to study predictive pathological factors for LR as well as the impact of LR on long-term survival outcomes solely in patients who are treated with wide local excision partial glansectomy laser ablation circumcision and glans resurfacing reflecting a lower risk OSS patient population defined as glans-sparing surgery
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