Urothelial Carcinoma BladderPhase 1TASUC-NeoNCT05839119
Targeting Androgen Signaling in Urothelial Cell Carcinoma - Neoadjuvant
A Phase 1 study testing Degarelix and Gemcitabine/Cisplatin in people with Urothelial Carcinoma Bladder and Androgen Receptor Positive, run by Brown University at 1 site in United States.
Trial summary
This study is for patients who have bladder cancer that invades into the muscle wall of the bladder. The standard treatment for patients with muscle invasive bladder cancer is to give 4 cycles of chemotherapy with the drugs cisplatin and gemcitabine, then to do an operation to remove the bladder (cystectomy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma Bladder, Androgen Receptor Positive
- What is being tested?
- Degarelix and Gemcitabine/Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2023to 17 Oct 2025
- Phase
- Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 3.1.1 Patients must have the following:
- Histologically confirmed muscle invasive urothelial cell carcinoma of the bladder (pT2 - pT4)
- Eligible for standard cisplatin/gemcitabine chemotherapy as determined by the treating Medical Oncologist
- 3.1.2 Patients must have muscle-invasive urothelial cell carcinoma of the bladder (pT2 - pT4, N0-N1, M0,) as determined by bladder biopsy or trans-urethral resection of bladder tumor (TURBT) and staging imaging studies. Patients with <10% non-urothelial histology will remain eligible for enrollment.
- 3.1.3 Androgen receptor positivity by IHC within the nucleus of tumor cells (as determined by study Pathologist) is required to receive study treatment.
- 3.1.4 Patients previously treated with intravesical therapy for non-muscle invasive urothelial carcinoma of the bladder are eligible for enrollment if the agent used was not gemcitabine or a platinum-containing agent (i.e, cisplatin, carboplatin, or oxaliplatin).
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- 3.1.5 Age ≥18 years.
- Because the safety and efficacy of Degarelix in pediatric patients have not been established, children (patients <18 years of age) are excluded from this study.
- 3.1.6 ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
- 3.1.7 Patients must have adequate organ and marrow function as defined below:
- absolute neutrophil count ≥1,000/mcL
- platelets ≥100,000/mcL
- total bilirubin ≤ institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤3 1.5 × institutional ULN
- creatinine ≤ institutional ULN OR glomerular filtration rate (GFR) ≥40 mL/min/1.73 m2
- 3.1.8 Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- 3.1.9 For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- 3.1.10 Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- 3.1.11 Patients with metastases, including treated brain metastases, are not eligible for enrollment.
- 3.1.12 Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen, and prior therapy did not include gemcitabine or a platinum-containing agent, are eligible for this trial.
- 3.1.13 Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
- 3.1.14 For women of childbearing potential, a negative serum pregnancy test within 7 days prior to registration
- 3.1.15 Women of childbearing potential and male participants must practice highly effective form of non-hormonal contraception throughout the study, which is defined as from study screening (ICF) through at least six months post last treatment. It must be documented this was discussed with the patient.
- The effects of Degarelix on the developing human fetus are unknown. However, based on animal studies and the mechanism of action, Degarelix may cause fetal loss. For this reason and that other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception.
- 3.1.16 Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- 3.2.1 Patients who have previously received systemic or intravesical gemcitabine or platinum-containing chemotherapy
- 3.2.2 Patients taking testosterone, estrogen, or other sex hormone modifying agents are excluded from this study as these medications may interfere with the activity of the study drug, Degarelix.
- 3.2.3 Patients with uncontrolled intercurrent illness, as determined by the treating physician
- 3.2.4 Patients who are pregnant or breastfeeding. (The effects of Degarelix on the developing human fetus are unknown. However, "based on findings in animal studies, [Degarelix] can cause fetal harm and loss of pregnancy when administered to a pregnant woman. In animal developmental and reproductive toxicity studies in rats and rabbits, oral administration of Degarelix during organogenesis caused embryo-fetal lethality and abortion as well as increased post-implantation loss and decreased the number of live fetuses in animals at doses less than the clinical loading dose based on body surface area." (Degarelix package insert). For this reason and the fact that other therapeutic agents used in this trial are known to be teratogenic, pregnant women are excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lifespan Cancer Institute
Providence, Rhode Island, 02912
About this study
Official title: Targeting Androgen Signaling in Urothelial Cell Carcinoma - Neoadjuvant (TASUC-Neo): A Pilot Study of Degarelix in Combination With Neoadjuvant Gemcitabine and Cisplatin in Muscle-Invasive Urothelial Cell Carcinoma of the Bladder
This study is for patients who have bladder cancer that invades into the muscle wall of the bladder. The standard treatment for patients with muscle invasive bladder cancer is to give 4 cycles of chemotherapy with the drugs cisplatin and gemcitabine, then to do an operation to remove the bladder (cystectomy).
In this study, the investigators will test participants' bladder cancer to see if their bladder cancer has a receptor for testosterone inside the bladder cancer cells. If it has the testosterone receptor participants will receive a medication called Degarelix that lowers testosterone levels in the blood. Degarelix will be given during the period that participants are receiving the standard of care chemotherapy drugs gemcitabine and cisplatin.
The purpose of this study is to evaluate the effects, good and bad, of adding Degarelix to standard chemotherapy for patients with bladder cancer that have the testosterone receptor.
Read the detailed description
Annually, over 80,000 people will be diagnosed with urothelial cell carcinoma (UCC) of the bladder in the USA, with over 17,000 deaths. For patients with muscle-invasive disease (stage II and IIIA), standard of care therapy is neoadjuvant chemotherapy followed by radical cystectomy. Neoadjuvant chemotherapy has been shown by multiple clinical trials and meta-analyses to improve pCR rates, disease free survival, and overall survival when compared to cystectomy alone. Specifically, neoadjuvant gemcitabine/cisplatin has been shown to be tolerable and effective and is a level 1 recommendation for treatment of muscle invasive bladder cancer by the National Comprehensive Cancer Network Guidelines.
The presence of a pCR in response to neoadjuvant chemotherapy is prognostic, but only about 35% of patients achieve a pCR. Thus improved neoadjuvant chemotherapy regimens are necessary to improve recurrence free survival and overall survival rates in patients with bladder cancer.
UCC is more common in men than women, with incidence rates of 3:1 to 4:1. This disparity persists even after controlling for smoking and occupational hazards/exposures and is likely influenced by androgen signaling. Androgen receptor (AR) positive UCC cells display increased proliferation, migration, and invasion in the presence of androgen and these effects are nullified in the presence of an AR antagonist. Preclinical studies show decreased rates of UCC incidence in response to a chemical carcinogen in castrated mice versus sham castrated mice and AR knockout mice versus AR intact mice. In retrospective human studies patients with UCC receiving androgen targeted therapy for concurrent prostate cancer had approximately 50% lower recurrence rates of UCC. Similarly, men receiving androgen targeted therapy for prostate cancer or benign prostatic hyperplasia have lower incidence rates of UCC than men not receiving androgen directed therapy.
Two prospective human clinical trials related to this concept have been performed. The first evaluated enzalutamide (an AR antagonist) as chemoprevention in non-muscle invasive UCC. This study was closed due to poor accrual after accruing only one patient. The second study added enzalutamide to standard chemotherapy in patients with metastatic UCC. Seven patients accrued at the therapeutic dose of enzalutamide. Overall, there was no signal for increased efficacy. However, one patient achieved a complete response lasting 2 years at last report. This patient was noted to have >90% positivity for AR in their tumor and, notably, was the only woman to participate in the study (and presumably had low testosterone levels). These data support further evaluation of androgen targeted therapy in AR+ UCC.
TASUC-neo is a pilot study conducted in patients with androgen receptor positive (AR+), pT2 - pT4, N0 - N1, M0 urothelial cell carcinoma (UCC) of the bladder. The study medication, Degarelix, will be administered concurrently with neoadjuvant gemcitabine/cisplatin.
- Being tested
- Degarelix, Gemcitabine/Cisplatin
- Keywords
- UCC, Bladder Cancer, AR+
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DegarelixDrug
Also called Firmagon Kit
initial dose is 240 mg administered as two 120 mg (3 mL) injections (SC), followed by subsequent doses at 80 mg (4 mL) administered as one injection (SC)
Gemcitabine/CisplatinCombination product
SOC Neoadjuvant Chemotherapy: Gemcitabine/Cisplatin 21-day cycles (4 cycles total)
- Gemcitabine: 1000 mg/m2 (IV) Days 1 and 8 of each cycle
- Cisplatin: 70 mg/m2 (if borderline renal function: 35 mg/m2) (IV) Day 1 of each cycle (if borderline renal function, days 1 and 8 of each cycle).
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | In patients with androgen receptor positive (AR+), pT2 - pT4, N0 - N1, M0 urothelial cell carcinoma (UCC) of the bladder. The study medication, Degarelix, will be administered concurrently with neoadjuvant gemcitabine/cisplatin.
* SOC Neoadjuvant Chemotherapy: Gemcitabine/Cisplatin 21-day cycles (4 cycles total)
* Gemcitabine: 1000 mg/m2 (IV) Days 1 and 8 of each cycle
* Cisplatin: 70 mg/m2 (if borderline renal function: 35 mg/m2) (IV) Day 1 of each cycle (if borderline renal function, days 1 and 8 of each cycle).
* Study Medication: Degarelix (SC) Every 28-days (3 cycles total) Day -7 to -2 of cycle 1, then as defined in the study calendar (approximately q28 days). "initial dose is 240 mg administered as two 120 mg (3 mL) injections (SC), followed by subsequent doses at 80 mg (4 mL) administered as one injection (SC) Receives: Drug: Degarelix; Combination Product: Gemcitabine/Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response rate (pCR)
Pathologic Complete Response (pCR): pCRis defined as no viable cancer cells in the resected bladder specimen.
Measured: Cystectomy following 4 (21-Day) cycles with Gemcitabine/Cisplatin
Secondary outcomes (4)
Rate of non-muscle invasive disease post neoadjuvant chemotherapy (ypT0, ypTis, ypTa, ypT1)
The effectiveness of the new combination will be assessed by pathological complete response rate (pCR). The exact one-sided 95% confidence intervals for the pCR will be reported.
Measured: Cystectomy following 4 (21-Day) cycles with Gemcitabine/Cisplatin
Relapse free survival at 2 years
Follow-up: from cystectomy. Year 1:q3 months, Year 2: q4 months
Measured: 2 yrs post Cystectomy
Relapse free survival at 5 years.
Follow-up: Five years from cystectomy. Year 1:q3 months, Year 2: q4 months,Years 3: q6 months,Years 4: and 5: annually ( +\- 3-week window).
Measured: 5 yrs post Cystectomy
AR positivity in patients with a non-pCR at cystectomy
As a secondary analysis investigators will assess the rate of non-muscle-invasive disease and report the exact one-sided 95% confidence interval.
Measured: Cystectomy following 4 (21-Day) cycles with Gemcitabine/Cisplatin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start2 Oct 2023
- Primary completion1 Jul 2025
- Study completion17 Oct 2025
Why it stopped: Principal Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial Carcinoma BladderStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Legorreta Cancer Center at Brown University, Lifespan, Cures Within Reach
- Responsible party
- Sponsor
- Investigators
- Sheldon L Holder, MD, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839119
- Sponsor's protocol ID
- BrUOG 428
- Acronym
- TASUC-Neo
- Status last verified
- Mar 2026
- First submitted
- 20 Apr 2023
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Androgen Signaling in Urothelial Cell Carcinoma - Neoadjuvant (TASUC-Neo): A Pilot Study of Degarelix in Combination With Neoadjuvant Gemcitabine and Cisplatin in Muscle-Invasive Urothelial Cell Carcinoma of the Bladder
- ClinicalTrials.gov ID
- NCT05839119
- Acronym / sponsor ID
- TASUC-Neo / BrUOG 428
- Keywords
- UCC, Bladder Cancer, AR+
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator left institution
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Legorreta Cancer Center at Brown University, Lifespan, Cures Within Reach
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 17 Oct 2025 (actual)
- First posted
- 3 May 2023 (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 is for patients who have bladder cancer that invades into the muscle wall of the bladder. The standard treatment for patients with muscle invasive bladder cancer is to give 4 cycles of chemotherapy with the drugs cisplatin and gemcitabine, then to do an operation to remove the bladder (cystectomy).
In this study, the investigators will test participants' bladder cancer to see if their bladder cancer has a receptor for testosterone inside the bladder cancer cells. If it has the testosterone receptor participants will receive a medication called Degarelix that lowers testosterone levels in the blood. Degarelix will be given during the period that participants are receiving the standard of care chemotherapy drugs gemcitabine and cisplatin.
The purpose of this study is to evaluate the effects, good and bad, of adding Degarelix to standard chemotherapy for patients with bladder cancer that have the testosterone receptor.
Detailed description
Annually, over 80,000 people will be diagnosed with urothelial cell carcinoma (UCC) of the bladder in the USA, with over 17,000 deaths. For patients with muscle-invasive disease (stage II and IIIA), standard of care therapy is neoadjuvant chemotherapy followed by radical cystectomy. Neoadjuvant chemotherapy has been shown by multiple clinical trials and meta-analyses to improve pCR rates, disease free survival, and overall survival when compared to cystectomy alone. Specifically, neoadjuvant gemcitabine/cisplatin has been shown to be tolerable and effective and is a level 1 recommendation for treatment of muscle invasive bladder cancer by the National Comprehensive Cancer Network Guidelines.
The presence of a pCR in response to neoadjuvant chemotherapy is prognostic, but only about 35% of patients achieve a pCR. Thus improved neoadjuvant chemotherapy regimens are necessary to improve recurrence free survival and overall survival rates in patients with bladder cancer.
UCC is more common in men than women, with incidence rates of 3:1 to 4:1. This disparity persists even after controlling for smoking and occupational hazards/exposures and is likely influenced by androgen signaling. Androgen receptor (AR) positive UCC cells display increased proliferation, migration, and invasion in the presence of androgen and these effects are nullified in the presence of an AR antagonist. Preclinical studies show decreased rates of UCC incidence in response to a chemical carcinogen in castrated mice versus sham castrated mice and AR knockout mice versus AR intact mice. In retrospective human studies patients with UCC receiving androgen targeted therapy for concurrent prostate cancer had approximately 50% lower recurrence rates of UCC. Similarly, men receiving androgen targeted therapy for prostate cancer or benign prostatic hyperplasia have lower incidence rates of UCC than men not receiving androgen directed therapy.
Two prospective human clinical trials related to this concept have been performed. The first evaluated enzalutamide (an AR antagonist) as chemoprevention in non-muscle invasive UCC. This study was closed due to poor accrual after accruing only one patient. The second study added enzalutamide to standard chemotherapy in patients with metastatic UCC. Seven patients accrued at the therapeutic dose of enzalutamide. Overall, there was no signal for increased efficacy. However, one patient achieved a complete response lasting 2 years at last report. This patient was noted to have >90% positivity for AR in their tumor and, notably, was the only woman to participate in the study (and presumably had low testosterone levels). These data support further evaluation of androgen targeted therapy in AR+ UCC.
TASUC-neo is a pilot study conducted in patients with androgen receptor positive (AR+), pT2 - pT4, N0 - N1, M0 urothelial cell carcinoma (UCC) of the bladder. The study medication, Degarelix, will be administered concurrently with neoadjuvant gemcitabine/cisplatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Degarelix, Combination Product: Gemcitabine/CisplatinIn patients with androgen receptor positive (AR+), pT2 - pT4, N0 - N1, M0 urothelial cell carcinoma (UCC) of the bladder. The study medication, Degarelix, will be administered concurrently with neoadjuvant gemcitabine/cisplatin. * SOC Neoadjuvant Chemotherapy: Gemcitabine/Cisplatin 21-day cycles (4 cycles total) * Gemcitabine: 1000 mg/m2 (IV) Days 1 and 8 of each cycle * Cisplatin: 70 mg/m2 (if borderline renal function: 35 mg/m2) (IV) Day 1 of each cycle (if borderline renal function, days 1 and 8 of each cycle). * Study Medication: Degarelix (SC) Every 28-days (3 cycles total) Day -7 to -2 of cycle 1, then as defined in the study calendar (approximately q28 days). "initial dose is 240 mg administered as two 120 mg (3 mL) injections (SC), followed by subsequent doses at 80 mg (4 mL) administered as one injection (SC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Histologically confirmed muscle invasive urothelial cell carcinoma of the bladder (pT2 - pT4)
- Eligible for standard cisplatin/gemcitabine chemotherapy as determined by the treating Medical Oncologist
- 3.1.2 Patients must have muscle-invasive urothelial cell carcinoma of the bladder (pT2 - pT4, N0-N1, M0,) as determined by bladder biopsy or trans-urethral resection of bladder tumor (TURBT) and staging imaging studies. Patients with <10% non-urothelial histology will remain eligible for enrollment.
- 3.1.3 Androgen receptor positivity by IHC within the nucleus of tumor cells (as determined by study Pathologist) is required to receive study treatment.
- 3.1.4 Patients previously treated with intravesical therapy for non-muscle invasive urothelial carcinoma of the bladder are eligible for enrollment if the agent used was not gemcitabine or a platinum-containing agent (i.e, cisplatin, carboplatin, or oxaliplatin).
Key exclusion criteria (4 listed)
- 3.2.1 Patients who have previously received systemic or intravesical gemcitabine or platinum-containing chemotherapy
- 3.2.2 Patients taking testosterone, estrogen, or other sex hormone modifying agents are excluded from this study as these medications may interfere with the activity of the study drug, Degarelix.
- 3.2.3 Patients with uncontrolled intercurrent illness, as determined by the treating physician
- 3.2.4 Patients who are pregnant or breastfeeding. (The effects of Degarelix on the developing human fetus are unknown. However, "based on findings in animal studies, [Degarelix] can cause fetal harm and loss of pregnancy when administered to a pregnant woman. In animal developmental and reproductive toxicity studies in rats and rabbits, oral administration of Degarelix during organogenesis caused embryo-fetal lethality and abortion as well as increased post-implantation loss and decreased the number of live fetuses in animals at doses less than the clinical loading dose based on body surface area." (Degarelix package insert). For this reason and the fact that other therapeutic agents used in this trial are known to be teratogenic, pregnant women are excluded from this study.
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 |
|---|---|---|
| DegarelixAlso: Firmagon Kitinitial dose is 240 mg administered as two 120 mg (3 mL) injections (SC), followed by subsequent doses at 80 mg (4 mL) administered as one injection (SC) | Drug | Treatment |
| Gemcitabine/CisplatinSOC Neoadjuvant Chemotherapy: Gemcitabine/Cisplatin 21-day cycles (4 cycles total) * Gemcitabine: 1000 mg/m2 (IV) Days 1 and 8 of each cycle * Cisplatin: 70 mg/m2 (if borderline renal function: 35 mg/m2) (IV) Day 1 of each cycle (if borderline renal function, days 1 and 8 of each cycle). | Combination product | Treatment |
Primary outcome
Pathologic complete response rate (pCR)
Time frame: Cystectomy following 4 (21-Day) cycles with Gemcitabine/Cisplatin
Pathologic Complete Response (pCR): pCRis defined as no viable cancer cells in the resected bladder specimen.
4 secondary outcomes
Rate of non-muscle invasive disease post neoadjuvant chemotherapy (ypT0, ypTis, ypTa, ypT1)
Time frame: Cystectomy following 4 (21-Day) cycles with Gemcitabine/Cisplatin
Relapse free survival at 2 years
Time frame: 2 yrs post Cystectomy
Relapse free survival at 5 years.
Time frame: 5 yrs post Cystectomy
AR positivity in patients with a non-pCR at cystectomy
Time frame: Cystectomy following 4 (21-Day) cycles with Gemcitabine/Cisplatin
Results and safety
The study was stopped early (reason given: Principal Investigator left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
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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.
Sheldon L Holder, MD, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Degarelix and Gemcitabine/Cisplatin in people with Urothelial Carcinoma Bladder and Androgen Receptor Positive, run by Brown University 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 25 inclusion and 4 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 2 Apr 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Principal Investigator left institution). 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?
Pathologic complete response rate (pCR) (time frame: Cystectomy following 4 (21-Day) cycles with Gemcitabine/Cisplatin). 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 2 Apr 2026.