Search Results
Phase III IGRT and SBRT VS IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer (NRG-GU005) (PSCI# 19-073)
The purpose of this study is to compare any good and bad effects of using stereotactic body radiation therapy (SBRT), a technique that gives treatment in a shorter amount of time compared to the usual radiation therapy. SBRT is experimental for treating this type of cancer. SBRT uses special equipment to position a participant and precisely deliver radiation to tumors in the body. Both the study and the usual radiation treatments use daily images to guide the radiation treatment to protect normal tissue. The study treatment, treatment over a shorter amount of time, may prevent the tumor from returning but it could also cause side effects. This study will allow the researchers to know whether this different approach using SBRT is better, the same, or worse than the usual approach. To be better, the study treatment should increase the time without the cancer coming back by six months or more compared to the usual approach, and show improvements in side effects to the bladder or rectum.
The purpose of this study is to compare any good and bad effects of using stereotactic body radiation therapy (SBRT), a technique that gives treatment in a shorter amount of time compared to the usual radiation therapy. SBRT is experimental for treating this type of cancer. SBRT uses special equipment to position a participant and precisely deliver radiation to tumors in the body. Both the study and the usual radiation treatments use daily images to guide the radiation treatment to protect normal tissue. The study treatment, treatment over a shorter amount of time, may prevent the tumor from returning but it could also cause side effects. This study will allow the researchers to know whether this different approach using SBRT is better, the same, or worse than the usual approach. To be better, the study treatment should increase the time without the cancer coming back by six months or more compared to the usual approach, and show improvements in side effects to the bladder or rectum.
Previously untreated localized adenocarcinoma of the prostate
Clinical stage by digital rectal exam of either T1c or T2a/b
The prostate volume must be < 60 cc as reported at time of biopsy or by separate measure with ultrasound or other imagining modalities including MRI or CT scan
Age is 18 years or older
Definitive T3 disease on MRI
Prior or current invasive malignancy with current evidence of active disease within the past 3 years
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; must be off treatment
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
PSCI 21-026 A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for CisplatinUndergoing Radical Cystectomy for Muscle Invasive Bladder Cancer(VOLGA)
A clinical trial for adults with Muscle Invasive Bladder Cancer. The study is looking at alternative treatments for those persons who cannot tolerate certain forms of chemotherapy.
This protocol contains two portions. The safety run in (SRI) and the main portion of the trial. The SRI will take place over three cycles of treatment prior to having cystectomy or 9 cycles if you have had a previous cystectomy. The main study will have the same schedule of activities. The only difference between the two is the SRI will look at how safe the drug combinations are and the main trial will look at how effective they are on treating muscle invasive bladder cancer.,
body weight above 30kg/66 pounds
history or an organ transplant
inflammatory bowel disease
Phase 2 Study of Bladder-SparIng ChemoradiatioN with Durvalumab (PSCI# 19-072) (EA8185)
The purpose of this study is to compare the usual treatment of chemotherapy and radiation to adding MEDI4736 (durvalumab) immunotherapy to the usual treatment. The addition of MEDI4736 (durvalumab) immunotherapy to the usual treatment may help shrink your cancer better than the current standard of care or usual approach for bladder cancer. But, it could also cause side effects, which are described in the risks section.This study will help determine if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the life of patients by 6 months or more compared to the usual approach.
If you decide to take part in this study, you will either get chemotherapy and radiation for 6-8 weeks, or you will get durvalumab immunotherapy in addition to chemotherapy and radiation for 6.5-8 weeks. After you finish your study treatment, your doctor will continue to follow you for up to 3 years. The follow-up will consist of visits to his or her office and CT scans of the bladder.
Patient must have histologically proven pure or mixed urothelial cancer of the bladder.
Patient must be ≥ 18 years of age.
Must have adequate renal function as evidenced by calculated (Cockcroft’s formula) creatinine clearance or 24 hours actual creatinine clearance ≥ 30mL/min.
Patient must have a life expectancy of at least 12 weeks, as determined by the treating physician.
Patient must not have received any previous radiation therapy to the pelvic area.
Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
Patients with a negative biopsy of nodes determined to be suspicious on imaging are not eligible.
Small cell carcinoma is excluded, however other variant histologies are permitted provided a component of urothelial carcinoma is present.
Phase III Trial of Concurrent Chemoradiotherapy with or without Atezolizumab (PSCI# 19-044)
The purpose of this study is to compare the effects, good and/or bad, of chemotherapy and radiation therapy with or without the use of atezolizumab, which is used to treat bladder cancer. The combination of chemotherapy, radiation therapy and the immunotherapy atezolizumab is considered experimental.
The purpose of this study is to compare the effects, good and/or bad, of chemotherapy and radiation therapy with or without the use of atezolizumab, which is used to treat bladder cancer. The combination of chemotherapy, radiation therapy and the immunotherapy atezolizumab is considered experimental.If you decide to take part in this study, you will receive combined chemotherapy and radiation therapy which is called “chemoradiotherapy” either with or without the study drug. The chemoradiotherapy you will receive is standard of care and what your doctor thinks is best. You will receive chemoradiotherapy for up to 7 weeks. If you are assigned to the group receiving study drug, you will take the drug for up to 6 months in addition the chemoradiotherapy.Your doctor will continue to follow your condition for up to 5 years after you register to the study, even though you have finished treatment in the first year. Your doctor will watch you for side effects and to see how your cancer affects you. You will have clinic visits at 3 months from the time you stop taking treatment for the first two years and then twice a year for the third year and once a year thereafter until 5 years after you register to the study
Patients must undergo radiological staging within 70 days prior to randomization. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI. Patients must not have evidence of T4bN1-3 disease.
Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and kidney function meets criteria specified.
Female patients of childbearing potential must have a serum pregnancy test prior to randomization.
Patients must be ≥ 18 years of age.
Patients must not have received prior treatment for muscle invasive bladder cancer including neoadjuvant chemotherapy for the current tumor.
Patients must not have a major surgical procedure within 28 days prior to randomization.
Patients must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation.
Patients must have adequate bone marrow function as evidenced by all of the following: ANC ≥ 1,500/microliter (mcL); platelets ≥ 100,000/mcL; Hemoglobin ≥ 9 g/dL. These results must be obtained within 28 days prior to randomization.
UroGen UR001
This study is being done is to test the safety of a drug called UGN-301 at different dose levels, either alone or with another drug called UGN-201, and to understand how these drugs interact with the bladder and body
If you decide to take part in this study and meet all of the requirements, you will receive 6 treatments, once per week for 6 weeks in a row. The medication treatments will be instilled via catheter into your bladder. There will be 11 total visits with blood draws at all of the visits. As part of screening for this study you will have to have a CT scan, a cystoscopy, and a bladder biopsy. At 3 months you will be required to return for a cystoscopy and bladder biopsy if necessary. Finally, there will be a follow up cystoscopy and bladder biopsy at 6 months.
Have confirmed recurrent NMIBC with HG Ta disease and/or CIS
Has a life expectancy > 12 months.
Be post menopausal, surgically sterile, or using a combination of 2 methods of birth control for maximally effective birth control
Have adequate organ and bone marrow function within 14 days of treatment initiation as determined by routine laboratory tests
Current or previous evidence of muscle invasive, locally advanced nonresectable, or metastatic urothelial carcinoma (ie, T2, T3, T4 and/or stage IV). High or low grade T1 disease.
Current systemic therapy for bladder cancer.
History of malignancy of other organ system within the past 5 years. Patients with genitourinary cancers other than urothelial cancer or prostate cancer that are under active surveillance
Prior therapy with an anti-CTLA-4, anti-PD-1, anti-PD-L1 agent, or with an agent directed to another co-inhibitory T-cell receptor.
PSCI 23-020: EA8212 A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)
If you decide to take part in this study, you will either get Gemcitabine and Docetaxel instilled through a catheter weekly in your bladder for up to 6 weeks, or you will get BCG instilled weekly in your bladder for up to 6 weeks. Your initial therapy may be followed with maintenance therapy.
If you decide to take part in this study, you will either get Gemcitabine and Docetaxel instilled through a catheter weekly in your bladder for up to 6 weeks, or you will get BCG instilled weekly in your bladder for up to 6 weeks. Your initial therapy may be followed with maintenance therapy.After you finish your treatment, your doctor will continue to follow your condition for 5 years with a combination of cystoscopies (inserting a telescope in your bladder) and CT scans (to take images of your body) in order to detect cancer recurrence.
Patient must have histologically confirmed high-grade non-muscle invasive urothelial carcinoma of the bladder (HgTa, HGT1, CIS, HgTa + CIS, or HGT1 + CIS stage)
Patient must have ECOG Performance Status 0-2.
Patient must have all visible papillary tumor resected by the treating urologist at the site registering the patient to this protocol prior to randomization.
Patient may have received prior systemic gemcitabine or docetaxel use if it was for a non-bladder malignancy
Patient must have not received prior intravesical therapy for bladder cancer, with the exception of perioperative chemotherapy at the time of TURBT.
Patient must not have pure squamous cell carcinoma or adenocarcinoma.
Patient must not have any component of neuroendocrine carcinoma (i.e., small cell or large cell).
Patient must not have any component of sarcomatoid, micropapillary, or plasmacytoid variant histology.
Genomic Profiling of Urothelial Cancers Study
The objective of this protocol is to study urothelial cancer with detailed health history, tumor and/or normal tissues available for genomic sequencing to study cancers in the bladder, upper urinary tract, and urethra. There will be 3 groups of subjects in this study:1)Urothelial cancer patients receiving care at Penn State Health2)Relatives of patients with urothelial cancer3)High risk-cohort of individuals with family history of urothelial cancers or inherited cancer syndromes (such as Lynch syndrome) candidates for urothelial cancer screening evaluation
All subjects will be asked to fill out questionnaires to assess risk factors for urinary cancer and document family history of cancer. You will be asked to provide a blood sample and urine sample for genetic testing. Patients with urothelial cancer will be asked to allow us to test leftover tissue from a past or future biopsy to test cancer and/or normal cells for certain mutations. We may also ask you for a saliva sample, cheek swab, skin biopsy, or nail clippings for comparison.
personal or family history of bladder cancer