CLINICAL TRIAL

Treatment for Cancer of Urethra

Metastatic
Waitlist Available · 18+ · All Sexes · Philadelphia, PA

This study is evaluating whether there are differences in the genetic makeup of tumors from people with metastatic urothelial cancer.

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About the trial for Cancer of Urethra

Eligible Conditions
Urethral Neoplasms · Urethral Cancer · Transitional Cell, Carcinoma · Bladder Cancer, Cancer · Cancer of the Ureter · Ureteral Neoplasms

Treatment Groups

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Tissue previously stored at enrolling institution
Tissue previously stored at an outside institution (other than enrolling institution)
The tissue specimen may come in the form of a block or slides accessed under UC-GENOME from enrolled subjects. Needle biopsy is also acceptable. Details regarding collection requirements, processing and shipping can be found in the Correlative Laboratory Manual (CLM).
IRB-approved written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Age ≥ 18 years at the time of consent.
Histologically or cytologically confirmed urothelial cancer of the bladder, urethra, ureter, or renal pelvis.
Metastatic urothelial cancer as defined by M1 (distant metastatic disease) and/or N3 (nodes outside of the true pelvis) at the time of registration.
Willing to provide access to tissue and blood for future research, including genetic studies.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From date of consent and retained indefinitely (estimate 10 years)
Screening: ~3 weeks
Treatment: Varies
Reporting: From date of consent and retained indefinitely (estimate 10 years)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From date of consent and retained indefinitely (estimate 10 years).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 2 primary outcomes and 8 secondary outcomes in patients with Cancer of Urethra. Measurement will happen over the course of From date of consent to receipt of NGS report by treating physician (estimate 14 days).

Proportion of subjects whose personalized NGS report includes targeted therapy treatment options
FROM DATE OF CONSENT TO RECEIPT OF NGS REPORT BY TREATING PHYSICIAN (ESTIMATE 14 DAYS)
Subjects whose treatment options include targeted therapy, of either approved or investigational drugs
FROM DATE OF CONSENT TO RECEIPT OF NGS REPORT BY TREATING PHYSICIAN (ESTIMATE 14 DAYS)
Proportion of subjects whose personalized NGS report includes potential clinical trial options
FROM DATE OF CONSENT TO RECEIPT OF NGS REPORT BY TREATING PHYSICIAN (ESTIMATE 14 DAYS)
Subjects who enroll in a clinical trial based on NGS results.
FROM DATE OF CONSENT TO RECEIPT OF NGS REPORT BY TREATING PHYSICIAN (ESTIMATE 14 DAYS)
Proportion of subjects who receive targeted therapy
FROM DATE OF CONSENT TO RECEIPT OF NGS REPORT BY TREATING PHYSICIAN (ESTIMATE 14 DAYS)
Subjects who receive targeted therapy, outside of a clinical trial, based on NGS results
FROM DATE OF CONSENT TO RECEIPT OF NGS REPORT BY TREATING PHYSICIAN (ESTIMATE 14 DAYS)
Proportion of subjects who receive NGS and have a personalized report generated with potential treatment options
FROM DATE OF CONSENT TO RECEIPT OF NGS REPORT (ESTIMATE 14 DAYS)
Subject-specific report that includes a summary of genomic alterations and potential therapeutic options based on the specific alterations and evidence discovered.
FROM DATE OF CONSENT TO RECEIPT OF NGS REPORT (ESTIMATE 14 DAYS)
Overall Survival (OS)
FROM TREATMENT INITIATION UNTIL DEATH AS A RESULT OF ANY CAUSE, UP TO 60 MONTHS
Compare the overall survival for patients with metastatic urothelial cancer who received a treatment based on the NGS results (on or off of a clinical trial) to those patients who did not
FROM TREATMENT INITIATION UNTIL DEATH AS A RESULT OF ANY CAUSE, UP TO 60 MONTHS
Collect comprehensive clinical outcomes for all subjects enrolled in this clinical trial
FROM DATE OF CONSENT UNTIL END OF THERAPY (ASSESSED UP TO 2 YEARS)
Subject clinical outcomes data compiled and recorded in a data repository, maintained in a secure platform, that will provide an archive for future research.
FROM DATE OF CONSENT UNTIL END OF THERAPY (ASSESSED UP TO 2 YEARS)
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes cancer of urethra?

If carcinoid syndrome is present then a diagnosis of carcinoid syndrome should also be considered. The most common cancer of the urethra is squamous cell carcinoma accounting for approximately 70% of the cases. Toxicity to vitamin B12 or 5-fluorouracil are important factors, but this toxicity is often transient.

Anonymous Patient Answer

How many people get cancer of urethra a year in the United States?

Around 20,000 new cases of urethral cancer are diagnosed each year in the United States, and it is the most common cause of male-limited symptoms of urethral disease.

Anonymous Patient Answer

Can cancer of urethra be cured?

It is difficult to cure [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) but it is possible to cure cancer of urethra. With correct diagnosis and treatment, cancer of urethra can also be cured in many cases.

Anonymous Patient Answer

What is cancer of urethra?

This article highlights an important feature of the cancers of the kidney, ureter and bladder (uretero-vesical tumour) and provides insight into the causes, staging and management of these conditions.

Anonymous Patient Answer

What are common treatments for cancer of urethra?

These included radiation treatment (with or without chemotherapy) in bladder carcinoma, radiation treatment (with or without chemotherapy) in cervix carcinoma, and neoadjuvant chemotherapy followed by surgery for uterine cancer. The use of brachytherapy (internal irradiation) was important in the treatment of cervical cancer, and the use of chemoradiation had a significant impact in managing bladder carcinoma.

Anonymous Patient Answer

What are the signs of cancer of urethra?

Symptoms of urethral cancer include frequency of urination, sudden urge to urinate and pain during urination. These symptoms may be not noticeable or noticeable for months prior to diagnosis of the bladder cancer. Other symptoms may include loss of appetite, difficulty eating, a lack of desire and frequent thirst of urination. The symptoms of bladder cancer may mimic those of urethral cancer. In males, prostate cancer may be an alternative to the symptoms that are typical of bladder cancer.

Anonymous Patient Answer

What is the average age someone gets cancer of urethra?

The average age at diagnosis was 70.6 with 61.6% of women and 29.4% of men diagnosed. Overall survival in women in this study was 92% and in men 74%. There was no difference between genders for the site of onset (urethral vs. prostate vs. other).

Anonymous Patient Answer

How does treatment work?

This is a very interesting and new study of how a treatment works for the treatment of cancer of the urethra (see Urethral Carcinoma). It shows the effect on one aspect of treatment, the Urethral Stem Cell Derived Tissue Engineered Nerve Grafts (UNX) to augment a successful therapy for this rare form of cancer.

Anonymous Patient Answer

What does treatment usually treat?

Treating patients with genitourinary cancer is challenging not only because of the high rate of comorbidities and cancer-related symptoms but also because of the variety of treatment options. Given the limited number of trials in this area, it is difficult to draw generalizations about the treatment of urologic cancers. Clinical trials have shown several treatment options (radiotherapy, chemotherapy, and biologic agents) are useful in improving disease-free survival in these most common cancers, namely, bladder, kidney, prostate, and urethra.

Anonymous Patient Answer

How serious can cancer of urethra be?

Of the urethral cancers, squamous cell carcinoma was the most serious with a five-year cancer-specific survival rate of 12%. In our experience, the prognosis of urethral cancers is poor. The main challenge in urogenital cancers is to minimize the risks of chemotherapy and radiotherapy.

Anonymous Patient Answer

What is treatment?

Many people are not undergoing adequate therapy; many were not receiving appropriate pain control; and only 4.4% of women who were receiving treatment received a complete course.

Anonymous Patient Answer

What are the common side effects of treatment?

Patients' side effects were common, but not debilitating, often and included cough, headache, constipation, diarrhea, chest/muscle aches/bruises, nausea and vomiting, rash, and fatigue. There were also side effects specific to the treatments.

Anonymous Patient Answer
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