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Hormone Therapy

Prostatectomy for Prostate Cancer

Phase 2

Recruiting

Led By Isaac Kim

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prostate deemed resectable by surgeon

Hemoglobin (HgB) >= 9 g/dL compatible for surgery

Must not have

Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to consent

Active spinal cord compression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well surgery, antiandrogen therapy, and/or docetaxel work in treating men with newly diagnosed prostate cancer that has spread to other places in the body.

Who is the study for?

Men with newly diagnosed metastatic prostate cancer who have started or plan to start antiandrogen therapy within the last 6 months. They must not have had previous local treatments for prostate cancer, should be able to undergo surgery, and have a life expectancy of more than 6 months. Their blood counts and liver enzymes need to be at certain levels, and they must be physically well enough (ECOG status of 0 or 1).

What is being tested?

The trial is testing if removing the prostate gland surgically combined with hormone-blocking therapy works better with or without docetaxel chemotherapy in men whose prostate cancer has spread. The study will compare how these different treatments affect tumor growth by killing cells, stopping cell division, or preventing spread.

What are the potential side effects?

Surgery can lead to pain, bleeding, infection risk and urinary issues. Antiandrogen therapy might cause hot flashes, sexual dysfunction and bone thinning. Docetaxel may result in hair loss, nausea/vomiting, fatigue and increased risk of infections due to low blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My surgeon has determined my prostate can be surgically removed.

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My hemoglobin level is at least 9 g/dL, making me fit for surgery.

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My cancer has spread, confirmed by scans or tests.

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My cancer has spread to distant lymph nodes, bones, or other organs.

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My platelet count is above 80,000, suitable for surgery.

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My liver enzyme ALT levels are within twice the normal limit.

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My prostate cancer was confirmed through a tissue examination.

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I have not had any local treatments for prostate cancer.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My liver enzyme AST levels are within twice the normal limit.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a blood clot in my leg or lung in the last 6 months.

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I have pressure on my spinal cord.

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I have been on hormone therapy for prostate cancer for over 6 months.

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I haven't had chemotherapy or radiotherapy for conditions other than prostate cancer in the last 3 weeks.

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I have had treatment directly on my prostate before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Failure-free survival (FFS)

Side effects data

From 2021 Phase 2 trial • 86 Patients • NCT03279250

74%

Hot flashes

71%

Fatigue

44%

Anemia

38%

Hyperglycemia

26%

AST increase

26%

Hypertension

26%

Lipase increase

24%

ALT increase

24%

Dry skin

21%

Rash

18%

ACTH increase

18%

Cholesterol high

15%

Dizziness

15%

Amylase increase

12%

Memory impairment

12%

White blood cell decrease

12%

Constipation

12%

Lymphocyte count decrease

Myalgia

Paresthesia

Weight loss

Arthralgia

Hypothyrodism

LDH increase

Erectile dysfunction

Headache

Personality change

Dysgeusia

Dyspnea

HbA1c increased

Hypertriglyceridemia

Insomnia

Irritability

Anorexia

Atrial fibrillation

Anxiety

Bruising

Hypercalcemia

Dehydration

TSH increased

100%

80%

60%

40%

20%

Study treatment Arm

Arm B (LHRHa, Apalutamide, Abiraterone Acetate)

Arm A (LHRHa, Apalutamide)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (ADT, radical prostatectomy, docetaxel)Experimental Treatment6 Interventions

Participants receive antiandrogen therapy for at least 1 month, then undergo cytoreductive radical prostatectomy. Participants continue antiandrogen therapy and may receive docetaxel prior to surgery at the discretion of the treating physician.

Group II: Arm I (ADT, docetaxel)Experimental Treatment5 Interventions

Participants receive antiandrogen therapy with or without docetaxel at the discretion of the treating physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radical Prostatectomy

2005

Completed Phase 2

~4550

Quality-of-Life Assessment

2017