Penile Cancer, RecurrentNCT06565585
Prediction of Local Recurrence and Its Impact on Long-term Outcomes After Low-risk Glans-sparing Surgery for Penile Squamous Cell Carcinoma
An observational study of Penile Cancer, Recurrent, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Penile Cancer, Recurrent
- What is being tested?
- Glans-sparing surgery
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Jun 2024to Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: We will collect data from patients operated in high-volume penile cancer centers on in the period from 1st of January 2000 to 1st of June 2023. All patients should have undergone glans-sparing surgery.
Who may be able to join
- Age over 18 years.
- Underwent low-risk OSS defined as: wide local excision, partial glansectomy, laser ablation, circumcision, and glans resurfacing for PSCC
Who cannot join
- Underwent partial or total penectomy as primary surgery
- regional lymph node involvement at presentation (cN+ stage)
- metastates at presentation (cM+ stage)
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read more
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.
Read the 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 36,068 new cases of penile cancer in 2020, with an age-standardized incidence of 0.8 per 100,000 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 2.89, 95% CI 2.02-4.14, <0.001) and cancer-specific survival (HR 5.64, 95% CI 3.45-9.22, P < 0.001) 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.
- Conditions
- Penile Cancer, Recurrent
- Being tested
- Glans-sparing surgery
- Keywords
- Penile cancer, Local recurrence, Organ-sparing surgery
- Medical subject headings
- Penile Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glans-sparing surgeryProcedure or surgery
Patients who underwent glans-sparing surgery
| Study group | Role | What they receive |
|---|---|---|
| Low-risk Glans-sparing surgery patients | Patients with lower-risk tumors who underwent glans-sparing surgery defined as circumcision, wide local excision, laser ablation, glans resurfacing and partial glansectomy. Receives: Procedure: Glans-sparing surgery | |
| High-risk glansectomy patients | Patients who underwent total glansectomy due to higher risk tumors resulting in a complete removal of all the glandulopreputhial epithelium. |
What is being measured
The primary outcome is the main question the study is designed to answer.
long-term oncologic outcomes (OS, CSS)
impact of local recurrence after glans-sparing surgery on long-term oncologic outcomes (OS, CSS)
Measured: 1/01/2000 - 1/06/2023
Secondary outcomes (1)
Predictive histopathological factors for local recurrence
Identify histopathological factors that might predict the occurrence of local recurrence
Measured: 1/01/2000 - 1/06/2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start3 Jun 2024
- Primary completionOct 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile Cancer, RecurrentStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maarten Albersen, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565585
- Sponsor's protocol ID
- S66471
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06565585
- Acronym / sponsor ID
- S66471
- Conditions
- Penile Cancer, Recurrent
- Keywords
- Penile cancer, Local recurrence, Organ-sparing surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 36,068 new cases of penile cancer in 2020, with an age-standardized incidence of 0.8 per 100,000 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 2.89, 95% CI 2.02-4.14, <0.001) and cancer-specific survival (HR 5.64, 95% CI 3.45-9.22, P < 0.001) 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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-risk Glans-sparing surgery patients | – | Procedure: Glans-sparing surgeryPatients with lower-risk tumors who underwent glans-sparing surgery defined as circumcision, wide local excision, laser ablation, glans resurfacing and partial glansectomy. |
| High-risk glansectomy patients | – | –Patients who underwent total glansectomy due to higher risk tumors resulting in a complete removal of all the glandulopreputhial epithelium. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will collect data from patients operated in high-volume penile cancer centers on in the period from 1st of January 2000 to 1st of June 2023. All patients should have undergone glans-sparing surgery.
Key inclusion criteria (2 listed)
- Age over 18 years.
- Underwent low-risk OSS defined as: wide local excision, partial glansectomy, laser ablation, circumcision, and glans resurfacing for PSCC
Key exclusion criteria (3 listed)
- Underwent partial or total penectomy as primary surgery
- regional lymph node involvement at presentation (cN+ stage)
- metastates at presentation (cM+ stage)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glans-sparing surgeryPatients who underwent glans-sparing surgery | Procedure or surgery | Low-risk Glans-sparing surgery patients |
Primary outcome
long-term oncologic outcomes (OS, CSS)
Time frame: 1/01/2000 - 1/06/2023
impact of local recurrence after glans-sparing surgery on long-term oncologic outcomes (OS, CSS)
1 secondary outcome
Predictive histopathological factors for local recurrence
Time frame: 1/01/2000 - 1/06/2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maarten Albersen, MD, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Penile Cancer, Recurrent, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
long-term oncologic outcomes (OS, CSS) (time frame: 1/01/2000 - 1/06/2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.