Focal Therapy + Hormonal Therapy for Prostate Cancer

Recruiting at 1 trial location

Overseen By Cancer Intake

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of Chicago

Must be taking: Androgen deprivation therapy

Must not be taking: Chemotherapy, Immunotherapy, others

Disqualifiers: Metastatic cancer, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

57 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of combining two treatments for prostate cancer: a surgical procedure called focal therapy and a hormone treatment known as androgen deprivation therapy (ADT). The goal is to determine if this combination can better treat prostate cancer that hasn't spread beyond the prostate. Men with intermediate-risk prostate cancer who haven't received other cancer treatments might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that androgen deprivation therapy (ADT) effectively treats prostate cancer by reducing certain hormones, leading to a significant reduction in tumor size for most patients. However, maintaining the treatment schedule can be challenging for some.

Studies indicate that adding apalutamide to ADT can improve survival rates. While generally safe, some may experience side effects like skin rash or itching, which can be managed by adjusting the dose.

Focal therapy, targeting only the cancerous part of the prostate, also appears promising. Most side effects are minor, with serious side effects occurring in only about 3% of patients.

Overall, these treatments have proven safe in humans, with manageable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining Androgen Deprivation Therapy (ADT), Apalutamide, and Focal Therapy for prostate cancer because it offers a more targeted approach. Unlike traditional treatments, which might involve full prostate removal or systemic therapies, this combination uses focal therapy to directly ablate cancerous tissue in the prostate, potentially preserving more healthy tissue and reducing side effects. Additionally, Apalutamide, an oral medication, works by blocking the action of androgens, which fuel prostate cancer growth, offering a potent one-two punch when used alongside ADT. This strategy aims to provide effective cancer control while maintaining a better quality of life for patients.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research has shown that androgen deprivation therapy (ADT) has effectively treated advanced prostate cancer for over 80 years by reducing male hormones that promote cancer growth. Studies indicate that ADT can significantly improve survival, with some trials showing a median survival of over 6 years. In this trial, participants will receive ADT followed by focal therapy. Focal therapy targets only the cancerous part of the prostate and has effectively treated localized prostate cancer, with about 80% of men having no significant cancer after treatment. Additionally, when combined with ADT, the drug apalutamide has lowered the risk of death and improved survival in prostate cancer patients. It also helps achieve undetectable levels of prostate-specific antigen (PSA), a marker used to monitor prostate cancer. Combining these treatments offers a promising way to manage prostate cancer effectively. ^{2 3 6 7 8}

Who Is on the Research Team?

Abhinav Sidana, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Ability to understand and sign a written informed consent document

My prostate cancer is considered intermediate-risk.

My other cancer does not affect this treatment's safety or success.

Exclusion Criteria

I have previously taken apalutamide.

I haven't had serious heart or stroke issues in the last year.

I have had surgery to remove both testicles.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Androgen Deprivation Therapy (ADT)

Participants receive androgen deprivation therapy as part of the treatment

4-5 months

Focal Prostate Ablation

Participants undergo focal prostate ablation therapy

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Androgen Deprivation Therapy (ADT)
• Apalutamide Oral Product
• Focal Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 2 Interventions

Participants will receive Androgen deprivation therapy (ADT) followed by Focal prostate ablation (focal therapy)

Androgen Deprivation Therapy (ADT) is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Androgen Deprivation Therapy for:

• Prostate cancer
• Metastatic prostate cancer
• Non-metastatic high-risk prostate cancer

Approved in United States as Androgen Deprivation Therapy for:

• Prostate cancer
• Metastatic prostate cancer
• Non-metastatic high-risk prostate cancer

Approved in Canada as Androgen Deprivation Therapy for:

• Prostate cancer
• Metastatic prostate cancer
• Non-metastatic high-risk prostate cancer

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Janssen, LP

Industry Sponsor

Trials

169

Recruited

329,000+

Founded

1953

Headquarters

Beerse, Belgium

Known For

Mental Health Therapies

Top Products

Imodium, Remicade, Invega, Procrit

Joaquin Duato

Janssen, LP

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen, LP

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11414637/

Current Clinical Aspects of Androgen Deprivation Therapy ... 3 For more than 80 years, androgen deprivation therapy (ADT) has proven to be effective in advanced tumor stages by suppressing serum androgens ...

2. ascopubs.org ascopubs.org/doi/10.1200/EDBK_433126

Balancing Hormone Therapy: Mitigating Adverse Effects of ... Treatment advances including ADT have led to improvements in PCa management and survival, with trials reporting median survival of over 6 years ...

3. openurologyandnephrologyjournal.com openurologyandnephrologyjournal.com/VOLUME/17/ELOCATOR/e1874303X237036/FULLTEXT/

6-month Formulations of Androgen Deprivation Therapy for ... A recent analysis found a high non-adherence rate of 84% for LHRH agonist injections based on dosing schedules used in pivotal trials. Method:.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7076308/

Efficacy of Androgen Deprivation Therapy in Patients with ... A study of 341 CRPC patients concluded that survival benefit of 2 to 6 months was obtained by continued testicular androgen suppression [9]. Therefore, studies ...

5. nature.com nature.com/articles/s41598-025-13480-8

Rapid and sustainable deep testosterone reduction ... Androgen deprivation therapy (ADT) is the cornerstone of treatment for patients with metastatic hormone-sensitive prostate cancer (mHSPC), ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4094624/

Androgen deprivation therapy for prostate cancer: long-term ... ADT can normalize serum prostate specific antigen in over 90% of patients and results in sizable tumor response in 80% to 90%. This treatment can be done either ...

7. cancer.gov cancer.gov/types/prostate/prostate-hormone-therapy-fact-sheet

Hormone Therapy for Prostate Cancer Fact Sheet - NCI Hormone therapies, which are treatments that decrease androgen levels or block androgen action, can inhibit the growth of such prostate cancers.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167814023000828

ESTRO-ACROP recommendations for evidence-based use ... Results. Key issues were identified and are discussed: It was concluded that no additional ADT is recommended for low-risk prostate cancer patients, whereas for ...