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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Androgen Deprivation Therapy (ADT)
DrugADT will be given for 3 months. Participants will receive a standard ADT as chosen by their study doctor.
Focal prostate ablation (focal therapy)
Procedure/SurgeryFocal prostate ablation (focal therapy) is a surgical procedure to destroy cancer cells by destroying a portion of the prostate instead of the whole prostate.
Treatment groups
57 Participants
are divided into 1 treatment groupGroup A: Treatment ArmExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of participants with clinically significant residual prostate cancer in ablated prostate tissue following study treatment
Proportion of participants that have residual cancer in ablated prostate tissue. Residual disease will be measured by MRI.
Time frame
End of Treatment (approximately 4-5 months)2
Number of participants with clinically significant residual prostate cancer in unablated prostate tissue following study treatment
Proportion of participants that have residual cancer in unablated prostate tissue. Residual disease will be measured by MRI.
Time frame
End of Treatment (approximately 4-5 months)3
Number and grade of complications [Safety]
Number and grade of complications will be reported. Number and grade of complications will be reported. The number and severity by Common Terminology Criteria for Adverse Events (CTCAE) grade of reported complications will be reported.
Time frame
6-months following treatmentSecondary outcomes
1
Measuring change in genitourinary and sexual function and health-related quality of life (measured by HRQoL)
Define change in genitourinary and sexual function from baseline following ADT and FT by measuring the subject's HRQoL
Time frame
6-and 12-months after FT2
PSA response to the combination treatment
Determine the PSA response to the combination treatment by measuring the subject's PSA at "baseline" (PSA at time of initial diagnosis) 3-months, 6-months, and 1-year from FT
Time frame
Baseline, 3-months, 6-months, and 1-year from FT3
Proportion of men converting therapy or dying of prostate cancer during study
Determine the proportion of men converting to whole gland therapy (radical prostatectomy or radiation therapy) and/or requiring systemic therapy and/or developing metastases and/or dying of PCa during the course of study.
Time frame
12 months after FT4
Post Treatment biopsy with no prostate cancer
Determine the proportion of men without any prostate cancer on any post treatment prostate biopsy.
Time frame
6 months after FTSponsors and contacts
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Source ClinicalTrials.gov