Customized TULSA-PRO Ablation Registry

 Data from patients who have undergone or are currently undergoing the transurethral ultrasound ablation (TULSA) procedure as part of their regular clinical care will be entered into this patient registry. The registry will shed light on actual outcomes of procedure safety and effectiveness and help researchers determine how a patient's quality of life changes over the course of their lifespan and follow-up visits.



General Requirements:

• Male
• >18 years old
• Candidate for TULSA-PRO treatment
• willing and able to sign the Informed Consent form

NCT05001477

ExoDx Prostate Evaluation in Active Surveillance Patient Population

This observational study aims to investigate whether patients with prostate cancer undergoing active monitoring can benefit from the ExoDx Prostate test when deciding whether to undergo a biopsy.



General Requirements:

• Male, 45+ years of age diagnosed with low-grade prostate cancer and currently monitoring with a urologist/provider. If you do not have a provider at the moment you can be seen with Dr Kella.

NCT05572099

A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX

 The patients in this multi-center, prospective, observational trial who are receiving ORGOVYX treatment. The objective of this study is to produce practical evidence regarding the safety and efficacy of ORGOVYX in patients with prostate cancer receiving standard clinical care, as well as the clinical course both during and after therapy with ORGOVYX.



General Requirements:

• Patients who are diagnosed with prostate cancer and initiating treatment with ORGOVYX at the time of enrollment or within 1 month prior to enrollment and who remain on treatment at enrollment
• Patients who are willing and able to complete PRO assessments during the study
• Patients who have reviewed and signed the informed consent form (ICF)

NCT05467176

Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy (CLARIFY)

The goal of this study is to evaluate how effectively 64Cu-SAR-bisPSMA PET imaging can identify regional nodal metastases (cancer spread to nearby lymph nodes). Specifically, the researchers aim to determine how accurate this imaging technique is in detecting lymph node metastases, which is crucial for diagnosis, treatment planning, and assessing the progression of cancer.

General Requirements:

• At least 18 years of age.
• Signed informed consent.
• Untreated, histologically confirmed adenocarcinoma of the prostate.
• High-risk or greater PC defined by National Comprehensive Cancer Network Guidelines Version 1.202327 (clinical stage ≥T3a, or Grade Group ≥4, or PSA >20 ng/mL).
• Patients electing to undergo Radical Prostatectomy.

NCT06056830

Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer (Solar-Stage)

This is a prospective, open-label Phase 3 study designed to evaluate the use of copper Cu-64 PSMA I&T injection for PET/CT imaging in patients with newly diagnosed prostate cancer. Specifically, the study focuses on patients categorized as having unfavorable intermediate high-risk, high-risk, or very high-risk prostate cancer.

General Requirements:

• At least 18 years of age.
• Signed informed consent.
• Untreated, histologically confirmed adenocarcinoma of the prostate.
• High-risk or greater PC defined by National Comprehensive Cancer Network Guidelines Version 1.202327 (clinical stage ≥T3a, or Grade Group ≥4, or PSA >20 ng/mL).
• Patients electing to undergo Radical Prostatectomy.

NCT06235151

An Observational Registry Assessing the Impact of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate Cancer

The goal of this observational research is to evaluate the real-world clinical utility of PYLARIFY PET imaging in prostate cancer patients. Specifically, the study aims to assess the long-term outcomes for patients who are eligible for a PSMA/PET scan.

General Requirements:

• Biological male at birth ≥ 21 years of age
• Histopathological confirmed prostate adenocarcinoma
• Patients meeting the enrollment criteria for either Cohort 1 or Cohort 2:
• Cohort 1:
• Patients who are newly diagnosed with prostate cancer (and have suspected metastases per the physician's discretion per standard of care assessment) and have not yet initiated any prostate cancer treatment and are referred to undergo PYLARIFY PET for identification of suspected metastases.
• OR
• Cohort 2:
• Patients who have previously received treatment for prostate cancer and are referred to undergo PYLARIFY PET or have received PYLARIFY PET for suspected recurrence of prostate cancer (based on an elevated PSA) within 60 days of consent to enroll in the registry
• Life expectancy ≥ 6 months as determined by the investigator
• Able and willing to provide informed consent and comply with the protocol requirements.

NCT05712473