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:

• Male ≥18 years of age at the time of signing the informed consent.
• Histologically or cytologically confirmed adenocarcinoma of prostate.
• Prostate cancer initially treated by:
• radical prostatectomy (RP) followed by adjuvant radiotherapy (ART) or salvage radiotherapy (SRT), or
• RP in participants who are unfit for ART or SRT, or
• primary radiotherapy (RT)
• High-risk biochemical recurrence (BCR), defined as
• Prostate-specific antigen doubling time (PSADT) <12 months AND
• PSA ≥0.2 ng/mL after ART or SRT post RP or after RP in participants who are unfit for ART or SRT, or
• PSA ≥2 ng/mL above the nadir after primary RT only
• Participants must undergo prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) within the 30-day Screening period using either 18F-DCFPyL (piflufolastat F 18) or 68Ga-PSMA-11
• Serum testosterone ≥150 ng/dL (5.2 nmol/L).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Blood counts at screening:
• Hemoglobin ≥9.0 g/dL
• Absolute neutrophil count (ANC) ≥1.5x109/L
• Platelet count ≥100x109/L
• Alanine aminotransferase (ALT) ≤1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) ≤1.5 x ULN
• Total bilirubin (TBL) ≤1.5 ULN, (except participants with a diagnosis of Gilbert’s disease)
• Estimated glomerular filtration rate (eGFR) >40 ml/min/1.73 m2 calculated by the CKD-EPI formula
• Sexually active male participants must agree to use contraception during the Treatment period and for at least 3 months after the last dose of study treatment, and refrain from donating sperm during this period.

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:

• Subjects must have histologically confirmed, non-muscle invasive urothelial (transitional cell) carcinoma with carcinoma in situ (CIS) (with or without papillary disease). Histological confirmation must occur within 60 days prior to first dose of study treatment.
• Predominant histologic component (>50%) must be urothelial (transitional cell) carcinoma. Pure variant histologies will be excluded.
• Subjects must have high-risk Bacillus Calmette-Guerin (BCG)-unresponsive disease.
• All visible papillary Ta/T1 tumors must be completely resected within 60 days prior to enrollment.
• Subjects must have satisfactory bladder function and the ability to retain study drug instillation for a minimum of 1 hour, even with premedication.

Exclusion Criteria:

• Current or prior history of muscle-invasive urothelial carcinoma (ie, T2, T3, or T4 disease) or metastatic disease.
• Nodal or metastatic disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) done within 3 months prior to the start of study treatment.
• Concomitant upper tract urothelial carcinoma as noted on CT or MRI urogram with contrast of abdomen/pelvis performed within 3 months prior to the start of study treatment.
• Subjects known to have prior or concomitant urothelial carcinoma of the prostatic urethra, as assessed by investigator within 6 months prior to the start of study treatment.
• Subject has received any other systemic anticancer therapy (eg, chemotherapy, biologic therapy, immunotherapy, targeted therapy, endocrine therapy, investigational agent) within 4 weeks of the first dose of study treatment or any intravesical therapy for treatment of NMIBC within 6 weeks prior to the start of study treatment.
• Subject has had any prior radiation to the bladder for urothelial cancer.

Inclusion:

Exclusion: