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Prediction of Local Recurrence and Its Impact on Long-term Outcomes After Low-risk Glans-sparing Surgery for Penile Squamous Cell Carcinoma

StatusUnknown
PhaseNot specified
Started2024-06-03
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 23, 2024 (before its estimated October 2024 completion). Its status may not reflect the trial's current state.

Amendment history

2026-09-06
minor
Trial status changed: Enrolling by Invitation → Unknown
2024-08-21
minor
Study Status, Study Description v1
Trial statusEnrolling by Invitation→Unknown
Study description+66 characters
[...] tion including both high-risk and low-risk tumors. However, wethe investigators recently published the results from a large, multicentric i [...] atients who were treated with upfront complete glansectomy. WeIt havewas found that LR after upfront glansectomy represents an under [...] age and high-grade disease as independent predictors of LR. WeThe investigators hypothesized that ourthese findings were caused by an enrichment of higher risk tumors in our cohort, since we solely studied glansectomy patients who undergo a complete removal of all the glandulopreputhial epithelium were studied. Conversely, weth [...] [...]
2024-08-20
minor
Original filing
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: 10.1111/bju.15297). 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.
Trial Details
NCT Number NCT06565585
Lead Sponsor Universitaire Ziekenhuizen KU Leuven
Conditions Penile Cancer, Recurrent
Enrollment 800 participants
Start Date 2024-06-03
Primary Completion 2024-10 (estimated)
Study Completion 2025-06 (estimated)
Updated on ClinicalTrials.gov 2024-08-23