Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Androgens

Hormones

Prolactin Release-Inhibiting Factors

Hormone Antagonists

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

Apalutamide 240 mg by mouth daily for a total of 6-months.

Apalutamide Oral Product

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).

Androgen Deprivation Therapy (ADT)

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.

Focal Therapy

Abhinav Sidana, MD

The purpose of this study is to determine the proportion of men with residual/recurrent clinically significant prostate cancer (Grade Group ≥2 disease) in the ablated or unablated prostate tissue following the combination treatment of 6-months of androgen deprivation therapy, apalutamide, and partial ablation of the prostate in men with newly diagnosed non-metastatic intermediate risk prostate cancer; specifically, men with a histopathologic diagnosis of Grade Group 2 \& 3, with prostate specific antigen level \<20 ng/mL.

And to assess the safety of the combination treatment of androgen deprivation therapy, apalutamide, and partial ablation of the prostate for the management of these patients.

Focal Prostate Ablation With Androgen Deprivation and Novel Hormonal Therapy for Intermediate Risk Prostate Cancer

Phase II Trial of Combination of Focal Prostate Ablation With Androgen Deprivation and Novel Hormonal Therapy for the Treatment of Intermediate Risk Prostate Cancer

Proportion of men with clinically significant prostate cancer (GG ≥2) in the ablated prostate tissue by performing a surveillance 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).

Proportion of men with clinically significant prostate cancer (GG ≥2) in the unablated prostate tissue by performing a surveillance 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).

Demonstrate the safety of combining ADT, apalutamide, and FT for the treatment of men with histopathologic diagnosis of GG 2 \& 3 PCa, with PSA level \< 20 ng/mL utilizing the NCI's CTCAE v.5 classification to quantify and characterize the incidence of AEs.

Define change in genitourinary and sexual function from baseline following ADT, apalutamide, and FT by measuring the subject's HRQoL

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

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.

Determine the proportion of men without any prostate cancer on any post treatment prostate biopsy.

Determine the proportion of men with normal baseline serum testosterone who had testosterone recovery (defined as testosterone levels \>300 ng/dL) at 6-, 9- and 12-months after FT.

Testosterone recovery: Number of men who have recovered normal serum testosterone levels will be expressed as proportions of total number of eugonadal patients and the 95% confidence interval of the proportion will be presented.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Focal Prostate Ablation With Androgen Deprivation and Novel Hormonal Therapy for Intermediate Risk Prostate Cancer	NCT05790213	Prostate Cancer	Apalutamide Ora... Androgen Depriv... Focal Therapy	18 Years -	University of Chicago
Focal Prostate Ablation With Androgen Deprivation and Novel Hormonal Therapy for Intermediate Risk Prostate Cancer	NCT05790213	Prostate Cancer	Apalutamide Ora... Androgen Depriv... Focal Therapy	18 Years -	University of Chicago

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