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Hormone Therapy
Focal Therapy + Hormonal Therapy for Prostate Cancer
Phase 2
Recruiting
Led By Abhinav Sidana, MD
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-, 9- and 12-months after ft.
Awards & highlights
Study Summary
This trial looks at a combined treatment for newly-diagnosed prostate cancer and its impact on recurrence and safety.
Who is the study for?
Men over 18 with non-metastatic intermediate-risk prostate cancer, PSA <20 ng/mL, and good organ function. They must be fit for general anesthesia and surgery, have a life expectancy of at least 10 years, agree to use contraception if sexually active with a woman who can bear children, and not have other health conditions that could affect the trial's safety or results.Check my eligibility
What is being tested?
The study tests whether combining six months of androgen deprivation therapy (ADT), apalutamide (a hormonal therapy pill), and focal therapy (targeted ablation) is effective in treating men with newly diagnosed intermediate-risk prostate cancer without causing significant residual or recurrent disease.See study design
What are the potential side effects?
Possible side effects include those related to ADT such as hot flashes, fatigue, reduced sex drive; apalutamide may cause rash, diarrhea, fractures; focal therapy might result in urinary issues or discomfort. The combination treatment's full range of side effects will be assessed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-, 9- and 12-months after ft.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-, 9- and 12-months after ft.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinically significant prostate cancer (GG ≥2) Proportion in ablated tissue measured by mpMRI and MRI-TB.
Clinically significant prostate cancer (GG ≥2) Proportion in unablated tissue measured by mpMRI and MRI-TB. GG stands for grade group, which is a way to describe prostate cancer. GG of ≥2 means intermediate (GG = 2 or 3) or high (GG = 4 or 5).
Incidence of Adverse Events to measure Safety of combination treatment (measured by CTCAE v5)
Secondary outcome measures
Measuring change in genitourinary and sexual function and health-related quality of life (measured by HRQoL)
PSA response to the combination treatment
Post Treatment biopsy with no prostate cancer
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Focal Prostate Ablation + Androgen Deprivation + Novel Hormonal TherapyExperimental Treatment3 Interventions
A. Apalutamide 240 mg by mouth daily for a total of 6-months B. ADT therapy will consist of any generic luteinizing hormone-releasing hormone agonist which will provide either 6-months of treatment or two injections every 3-months. (e.g., one injection with a treatment period of 6 months or two injections, one at drug start and one 3-months later).
C. Focal therapy to be completed within 8- to 12-weeks of the initiation of apalutamide but after the completion of the 8-week mpMRI to allow for it to be used in FT planning
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Androgen Deprivation Therapy (ADT)
2005
Completed Phase 3
~530
Focal Therapy
2016
Completed Phase 1
~10
Find a Location
Who is running the clinical trial?
University of CincinnatiLead Sponsor
428 Previous Clinical Trials
634,337 Total Patients Enrolled
4 Trials studying Prostate Cancer
392 Patients Enrolled for Prostate Cancer
Janssen, LPIndustry Sponsor
160 Previous Clinical Trials
307,933 Total Patients Enrolled
5 Trials studying Prostate Cancer
280 Patients Enrolled for Prostate Cancer
Abhinav Sidana, MDPrincipal InvestigatorUniversity of Cincinnati
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously taken apalutamide.My prostate cancer is considered intermediate-risk.I haven't had serious heart or stroke issues in the last year.I have had surgery to remove both testicles.My other cancer does not affect this treatment's safety or success.I cannot stop taking certain medications before starting apalutamide.My prostate cancer has spread beyond the prostate.I have received treatment for prostate cancer before.I do not have any severe illnesses that are not under control.I have a history of seizures or conditions that could lead to seizures.My prostate cancer has not spread beyond the prostate.I am a man aged 18 or older.I am healthy enough for general anesthesia and surgery.I cannot undergo an MRI scan of my pelvis.I can take care of myself but might not be able to do active work.My organs and bone marrow are working well.I am allergic to some of the components in the study drug.
Research Study Groups:
This trial has the following groups:- Group 1: Focal Prostate Ablation + Androgen Deprivation + Novel Hormonal Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an acceptable degree of risk associated with the combination of Focal Prostate Ablation, Androgen Deprivation and Novel Hormonal Therapy?
"With Phase 2 trial data supporting its safety, Focal Prostate Ablation + Androgen Deprivation + Novel Hormonal Therapy was rated a score of 2 on the Power scale."
Answered by AI
Are there any vacancies remaining in this clinical investigation?
"According to the details available on clinicaltrials.gov, this research project is not presently enrolling participants. Initially posted on April 1st 2023 and last updated March 27th of that same year, this trial is currently inactive; however there are 1321 other trials actively recruiting patients at present."
Answered by AI
What objectives is the research team striving to achieve?
"Per the trial sponsor, Janssen LP's reportage, the primary outcome will be clinically relevant prostate cancer (Grade Group ≥2) detected in unablated tissue measured by mpMRI and MRI-TB over a six month post FT period. Additionally, secondary objectives such as PSA response to combined treatment, prevalence of men shifting to whole gland therapy or requiring systemic treatment/developing metastases/dying of PCa during study course and lack of prostate cancer on post-treatment biopsy are all being examined."
Answered by AI
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