Clinical trial · Observational
Prediction of Local Recurrence and Its Impact on Long-term Outcomes After Low-risk Glans-sparing Surgery for Penile Squamous Cell Carcinoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Penile Cancer, Recurrent | Malignant Penile Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Glans-sparing surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Low-risk Glans-sparing surgery patients
- description
- Patients with lower-risk tumors who underwent glans-sparing surgery defined as circumcision, wide local excision, laser ablation, glans resurfacing and partial glansectomy.
- interventionNames
- Procedure: Glans-sparing surgery
- label
- High-risk glansectomy patients
- description
- Patients who underwent total glansectomy due to higher risk tumors resulting in a complete removal of all the glandulopreputhial epithelium.
Primary outcomes (1)
- measure
- long-term oncologic outcomes (OS, CSS)
- timeFrame
- 1/01/2000 - 1/06/2023
- description
- impact of local recurrence after glans-sparing surgery on long-term oncologic outcomes (OS, CSS)
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age over 18 years. * Underwent low-risk OSS defined as: wide local excision, partial glansectomy, laser ablation, circumcision, and glans resurfacing for PSCC Exclusion Criteria: * Underwent partial or total penectomy as primary surgery * regional lymph node involvement at presentation (cN+ stage) * metastates at presentation (cM+ stage)
References
Publications (0)
Data not yet available