Clinical Trials

Inclusion Criteria

• Age ≥40 years and ≤85 years
• Scheduled for RP for clinically localized prostate cancer

Exclusion Criteria

• Prior major pelvic surgery or radiotherapy
• Prior focal therapy or radiotherapy for prostate cancer

Inclusion Criteria:

• Male patients ages 18-89 undergoing abdominal or pelvic surgery

Exclusion Criteria:

• Men with prior history of testosterone replacement therapy (TRT)
• Patients unwilling to provide consent

• Recurrent, non-muscle-invasive or muscle-invasive urothelial carcinoma of the bladder
• Activating tumor FGFR mutation or fusion, as determined by local* or central testing, approved by the sponsor prior to the start of study treatment
• Adequate bone marrow, liver, and renal function
• Must sign an informed consent form (ICF)indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
• Willing and able to adhere to the lifestyle restrictions specified in this protocol
• No Concurrent extra-vesical (ie, urethra, ureter, renal pelvis) transitional cell carcinoma of the urothelium
• No prior treatment with FGFR inhibitor
• Have not received radiotherapy ≤6 months prior to the planned start of study treatment
• No Indwelling urinary catheter
• Bladder post-void residual volume (PVR) >350 mL after second voided urine
• Cannot have a History of uncontrolled cardiovascular disease

Inclusion Criteria

• Males 18 -100 undergoing HoLEP who have had an inadequate response to anticholinergic medications
• Component of OAB symptoms including frequency, nocturia, urgency, and/or urge related incontinence
• Willing to sign the Informed Consent Form
• Able to read, understand, and complete patient questionnaires.

Exclusion Criteria

• Allergy or hypersensitivity to OnabotulinumtoxinA injections
• Patients having a concurrent ureteroscopy +/- laser lithotripsy, percutaneous nephrolithotomy, or non-urologic surgery at the time of their HoLEP
• Anticipated need for perineal urethrostomy at the time of HoLEPPatients with prior pelvic radiation
• Patients with a history of bladder cancer with or without BCG therapy within the last 12 months
• Patients who lack decisional capacity
• Active urinary tract infection

Inclusion Criteria

• Adults >18 years old
• Diagnosis of upper tract urothelial cancer (UTUC).
• Meet at least one of the following criteria:
• Have been treated with Jelmyto after April 2020
• Currently undergoing treatment with Jelmyto
• Will receive Jelmyto

Inclusion Criteria:

• Undergoing ureteroscopy and laser lithotripsy
• Stone size ≥8 but < 20 mm in the proximal ureter or kidney. Multiple stones ≤4 are allowed. Bilateral surgeries are allowed
• Willing to sign informed consent

Exclusion Criteria:

• Staged surgery
• Nephrocalcinosis
• Participant is less than 18 years of age
• Inability to provide informed consent
• Members of vulnerable patient populations

Inclusion Criteria:

• Healthy men (ECOG 0-1)
• > 18 years old with at least 10 year life expectancy.
• Histologically proven Gleason Grade Group 1 or 2 adenocarcinoma of the prostate o Last prostate cancer containing biopsy performed within 3-15mo prior to screening. Biopsy must have been ≥10 core biopsy and informed by prior mpMRI
• Prostate cancer categorized as low risk or favorable risk by NCCN criteria (low risk is defined as T1c-T2a, PSA<10ng/ml, Gleason Grade Group 1 (Gleason 3+3=6) disease) and favorable intermediate risk as having no more than one of the following intermediate risk features, clinical T2b-T2c disease, PSA 10-20ng/ml, Gleason Grade Group 2 (Gleason score 3+4=7)).
• Decipher genomic classifier score from prior biopsy >0.45
• Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures.
• Concurrent diseases and malignancies are permitted
• Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on the study
• Willing to undergo prostate biopsy prior to non-surgical treatment of prostate cancer and within 90 days of PET-MRI imaging

Exclusion Criteria

• Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer.
• NCCN Very low risk category (T1c and Gleason Grade Group 1 (Gleason Score 3+3=6), PSA <10 ng/mL, fewer than 3 prostate biopsy cores positive, ≤50% cancer in any core, PSA density <0.15 ng/mL/g).
• Decipher score <0.45
• Prior bladder outlet procedure (i.e. HoLEP, TURP, Urolift, Rezum)
• Prohibited medications: use of 5 alpha reductase inhibitor or androgen deprivation therapy (i.e. leuprolide, relugolix) within 1 month of screening
• Contra-indication or relative contra-indication to MRI (i.e. pacemaker) o History of hip replacement
• Subject has received investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.

Inclusion Criteria

• Adult >18 years old
• Suspected or known non-muscle invasive bladder cancer on the basis of a prior cystoscopy, or undergoing surveillance cystoscopy for carcinoma of the bladder

Exclusion Criteria

• Porphyria
• Gross hematuria
• Known hypersensitivity to hexaminolevulinate or aminolevulinate derivatives

Inclusion Criteria:

Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell histology is predominant histology).

a. Cohort A: Histologically confirmed CIS (with or without Ta/T1 disease); Cohort B: Histologically confirmed high-grade papillary disease (Ta/T1 only).

Currently eligible for intravesical BCG therapy.

Age ≥ 18 years.

BCG-naive disease as defined as either of the following:

a. Have not received prior intravesical BCG; or b. Previously received BCG, but stopped receiving more than 3 years before date of randomization.

Exclusion Criteria:

Prior BCG treatment in the last 3 years or known hypersensitivity to BCG or known history of BCG Unresponsive NMIBC. Patients who have received more than a single-dose post-operative treatment of mitomycin-C or gemcitabine following the most recent screening TURBT/biopsy are excluded.

History of or evidence of muscle-invasive, locally advanced, metastatic and/or extravesical bladder cancer or any other cancer within the past 5 years, except: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage 1 or 2 cancer from which the patient is currently in complete remission, or stable prostate cancer (under active surveillance or hormone control).

Inclusion Criteria:

1. People with prostates ≥40 years of age

2. Documented germline pathogenic variant in known or suspected genes associated with

prostate cancer risk.

Exclusion Criteria:

1. Prior diagnosis of prostate cancer

2. Medical contraindication to any of the study procedures (e.g., prostate biopsy)

3. For all cancer types except non-melanoma skin cancer, any cancer treatment with curative intent within the past 12 months (e.g., surgery, radiation, chemotherapy, immunotherapy)

4. Prior or concurrent participation in an interventional clinical trial aimed at preventing cancer for people with germline variants associated with increased prostate cancer risk.

5. Unable to provide written informed consent

6. Unable or unwilling to complete clinical care and study procedures as indicated by the study protocol.

Inclusion Criteria:

1. Patients 18 years and older

2. Patients undergoing reconstructive urologic surgery, including urethroplasty, procedures for lichen sclerosis, ureteral reconstruction, and surgery for male incontinence.

Exclusion Criteria:

1. Patients not undergoing procedures listed above.

2. Patients unable to provide informed consent.

3. Patients under 18 years of age.