Prostate Cancer Treatment Using Androgen Deprivation Therapy and Focal Prostate Ablation
ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Chicago
About this trial
The purpose of this research is to gather information on the safety and effectiveness of combining focal prostate ablation therapy ((aka Focal Therapy, a surgical procedure) and androgen deprivation therapy (hormone therapy).
Eligibility criteria
Qualifiers
No mpMRI evidence of extra-prostatic extension (EPE) or seminal vesicle invasion, and if seminal vesical invasion is suspected, it must be excluded by prostate biopsy.
Subjects must have chosen to get Focal Therapy for the treatment of prostate cancer.
Subjects must have confirmed non-metastatic PCa following SOC screening for patients with unfavorable intermediate-risk PCa, a combination of computed tomography imaging of the abdomen and pelvis (CTAP) and technetium-99-mDP nuclear medicine bone scan (BS) and/or prostate-specific membrane antigen positron emission tomography (PSMA/PET) scan prior to enrollment. The imaging studies should be obtained within 6-months of enrollment. Additional imaging is not required for men with favorable intermediate-risk PCa.
Subject must be male ≥ 18 years-old.
Disqualifiers
Subject has had prior or current PCa therapies, such as biologic, chemotherapy, hormone therapy, radiotherapy or surgery for PCa. Subjects may not have had undergone pelvic radiation, chemotherapy or immunotherapy treatment for a separate hematologic or visceral malignancy within 6-months of enrollment in the present study.
Subjects with locally advanced, nodal or metastatic prostate cancer.
Subjects who are unfit for pelvic mpMRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, metallic implants that are likely to contribute to significant image artifacts, allergy or contraindication to gadolinium contrast agent.
History of allergy or intolerance to study drug components.
Trial design
Treatments tested in this trial
- Androgen Deprivation Therapy (ADT)
- Focal prostate ablation (focal therapy)
Treatment groups
57 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov