Penile CarcinomaNCT04996849
Contemporary Characteristics of Penile Cancer
An observational study of Penile Carcinoma and Squamous Cell Carcinoma of the Penis, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study develops a prospective database of patients who are evaluated and treated for penile cancer. This will facilitate analyzing trends in cancer incidence, risk factors, treatment, complications, and tumor progression. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Penile Carcinoma, Squamous Cell Carcinoma of the Penis
- What is being tested?
- Data Capture and Questionnaire Administration
- How many people
- 499 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2004to 17 Sep 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with a primary penile malignancy
Who may be able to join
- All diagnosed patients with a primary penile malignancy, including those with squamous carcinoma
Who cannot join
- No patient meeting the above criteria will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contemporary Characteristics of Penile Carcinoma: at M.D. Anderson Cancer Center, and Harris Health System and Katy, Sugar Land, the Woodlands and Bay Area Regional Care Centers
This study develops a prospective database of patients who are evaluated and treated for penile cancer. This will facilitate analyzing trends in cancer incidence, risk factors, treatment, complications, and tumor progression. It will also prospectively validate the importance of pathological prognostic factors previously reported and outcome related to contemporary treatment.
Read the detailed description
PRIMARY OBJECTIVE:
- To prospectively collect data on the presenting features, management and outcome of penile carcinoma at M.D. Anderson Cancer Center, and Harris Health System and Katy, Sugar Land, The Woodlands and Bay Area Regional Care Centers.
OUTLINE:
Patients undergo data collection every 6 months for up to 15 years.
- Being tested
- Data Capture, Questionnaire Administration
- Medical subject headings
- Penile Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data CaptureOther
Data collected
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Observational (data collection) | Patients undergo data collection every 6 months for up to 15 years. Receives: Other: Data Capture; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prospectively collect data on the presenting features, management and outcome of penile carcinoma
Descriptive statistics will be utilized where applicable to address questions relevant to the study aims.
Measured: Up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start22 Apr 2004
- Primary completion17 Sep 2025
- Study completion17 Sep 2025
Why it stopped: \<75% participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 499 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Curtis A Pettaway, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996849
- Sponsor's protocol ID
- PCR04-0148
- Other IDs
- NCI-2021-07693, PCR04-0148
- Status last verified
- Sep 2025
- First submitted
- 30 Jul 2021
- Last updated
- 24 Sep 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contemporary Characteristics of Penile Carcinoma: at M.D. Anderson Cancer Center, and Harris Health System and Katy, Sugar Land, the Woodlands and Bay Area Regional Care Centers
- ClinicalTrials.gov ID
- NCT04996849
- Acronym / sponsor ID
- PCR04-0148
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: \<75% participation
- Enrolment
- 499 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Apr 2004 (actual)
- Primary completion
- 17 Sep 2025 (actual)
- Study completion
- 17 Sep 2025 (actual)
- First posted
- 9 Aug 2021 (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.
This study develops a prospective database of patients who are evaluated and treated for penile cancer. This will facilitate analyzing trends in cancer incidence, risk factors, treatment, complications, and tumor progression. It will also prospectively validate the importance of pathological prognostic factors previously reported and outcome related to contemporary treatment.
Detailed description
PRIMARY OBJECTIVE:
- To prospectively collect data on the presenting features, management and outcome of penile carcinoma at M.D. Anderson Cancer Center, and Harris Health System and Katy, Sugar Land, The Woodlands and Bay Area Regional Care Centers.
OUTLINE:
Patients undergo data collection every 6 months for up to 15 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (data collection) | – | Other: Data Capture, Other: Questionnaire AdministrationPatients undergo data collection every 6 months for up to 15 years. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with a primary penile malignancy
Key inclusion criteria (1 listed)
- All diagnosed patients with a primary penile malignancy, including those with squamous carcinoma
Key exclusion criteria (1 listed)
- No patient meeting the above criteria will be excluded
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 |
|---|---|---|
| Data CaptureData collected | Other | Observational (data collection) |
| Questionnaire AdministrationAncillary studies | Other | Observational (data collection) |
Primary outcome
Prospectively collect data on the presenting features, management and outcome of penile carcinoma
Time frame: Up to 15 years
Descriptive statistics will be utilized where applicable to address questions relevant to the study aims.
Results and safety
The study was stopped early (reason given: \<75% participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Curtis A Pettaway principal investigator
M.D. Anderson Cancer Center
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 Carcinoma and Squamous Cell Carcinoma of the Penis, run by M.D. Anderson Cancer Center at 1 site in United States.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 24 Sep 2025. 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 United States. 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?
The study was stopped early (reason given: \<75% participation). 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?
Prospectively collect data on the presenting features, management and outcome of penile carcinoma (time frame: Up to 15 years). 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 24 Sep 2025.