Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy

NCT03412396 | Active Not Recruiting Phase 2 Results FDA Drug

• 2 other identifiers: 2015-0693NCI-2018-00902
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well apalutamide works in treating patients with prostate cancer before radical prostatectomy. Androgen can cause the growth of prostate cancer cells. Hormone therapy using apalutamide may fight prostate cancer by lowering the amount of androgen the body makes and may make it less likely for patients to receive radiation therapy after surgery.

Conditions

Prostate Adenocarcinoma; Stage IIB Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Surgical Pathology Features at Risk of Pelvic Radiation Therapy

  To determine whether 6 months (24 weeks) of neoadjuvant apalutamide prior to prostatectomy for intermediate risk prostate cancer results in a reduction of surgical pathology features at risk of pelvic RT, defined as pT3a, pT3b stage, N1 and/or positive surgical margin. All patients who receive at least 9 weeks of neoadjuvant therapy of apalutamide and undergo radical prostatectomy will be evaluable for the primary endpoint.

  Assessed at time of surgical specimen microscopic evalution Assessed at time of surgical specimen microscopic evaluation

Secondary Outcomes (3)

• Safety and Tolerability of 6 Months Neoadjuvant Apalutamide Followed by Radical Prostatectomy

  From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.

• Clinical Complete Responses (pT0) and "Near" Complete Responses (<6mm Total Tumor Volume)

  Assessed at time of surgical specimen microscopic evaluation

• Biochemical Recurrence Rate

  From surgery through 3-year post-op follow up

Study Arms (1)

Treatment (apalutamide, radical prostatectomy)

EXPERIMENTAL

Patients receive apalutamide PO daily for 24 weeks in the absence of disease progression or unacceptable toxicity. Within 2 weeks of completing apalutamide, patients undergo radical prostatectomy.

Drug: Apalutamide; Other: Quality-of-Life Assessment; Procedure: Radical Prostatectomy

Interventions

Apalutamide DRUG

Given PO

Also known as: ARN 509, ARN-509, ARN509, Erleada, JNJ 56021927, JNJ-56021927

Treatment (apalutamide, radical prostatectomy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (apalutamide, radical prostatectomy)

Radical Prostatectomy PROCEDURE

Undergo radical prostatectomy

Also known as: Prostatovesiculectomy

Treatment (apalutamide, radical prostatectomy)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent
• Histologically confirmed adenocarcinoma of the prostate
• A minimum of 10 core biopsies have been performed at baseline and available. A prostate biopsy within 6 months from screening is allowed for entry requirements. Biopsies performed within 6-12 months from screening are acceptable if the treating physician would allow treatment without further biopsy. Patients must meet intermediate risk criteria from Gleason score, T stage, and prostate-specific antigen (PSA) value by National Comprehensive Cancer Network (NCCN) criteria: cT2b-T2c or Gleason 7 (3+4 or 4+3) or PSA 10-20 ng/mL. In addition, the Gleason 3+4 or 4+3 must be present
• Pathology review at MD Anderson Cancer Center. The volume of disease must be high enough for the surgeon to agree to include an extended template pelvic lymph node dissection
• Serum testosterone \> 200 ng/mL
• Patient and urologist must agree that patient is suitable for prostatectomy
• No evidence of metastases on imaging. This risk group does not require metastatic studies, but if performed they must be negative (as determined by urologist or radiologist). Suspicious lymph nodes permissible if \< 10 mm
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Hemoglobin \>= 10.0 g/dL
• Platelet count \>= 100,000 x 10\^9/microliter
• Glomerular filtration rate (GFR) \>= 45 mL/min
• Serum potassium \>= 3.5 mmol/L
• Serum albumin \>= 3.0 g/dL
• Able to swallow the study drug whole as a tablet
• Serum bilirubin \< 1.5 x upper limit of normal (ULN); Note: In subjects with Gilbert's syndrome, if total bilirubin is \> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =\< 1.5 x ULN, subject may be eligible

You may not qualify if:

• Histological variants in the primary tumor, other than adenocarcinoma; for example: neuroendocrine tumor, small cell or sarcomatoid
• Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
• PSA is \> than 20 ng/mL (NOTE: unless other valid PSAs were =\< 20 and the treating physician considers a value \> 20 related to the biopsy or other non-malignant cause. The treating physician must consider the patient intermediate risk in aggregate)
• Uncontrolled hypertension. Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy. Note that this is NOT a criterion related to particular blood pressure (BP) results at the time of assessment for eligibility, nor does it apply to acute BP excursions that are related to iatrogenic causes, acute pain or other transient, reversible causes
• Active or symptomatic viral hepatitis or chronic liver disease
• Clinically significant heart disease as evidenced by myocardial infarction, arterial thrombotic events in the past 6 months, severe or unstable angina, class III-IV New York Heart Association heart failure
• Other malignancy, except non-melanoma skin cancer, that is active or has a \>= 30% probability of recurrence within 12 months
• History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug
• Known history of pituitary and/or adrenal disease (or dysfunction)
• Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or luteinizing hormone-releasing hormone (LHRH) agonists/antagonists
• Severely compromised immunological state, including being positive for the human immunodeficiency virus (HIV)
• Patients who are not appropriate surgical candidates for radical prostatectomy based on the evaluation of co-existent medical diseases and competing potential causes of death (such as but not limited to, unstable angina, myocardial infarction within the previous 6 months, or use of ongoing maintenance therapy for life-threatening ventricular arrhythmia, uncontrolled hypertension)
• History of seizure, seizure disorder, or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumors, brain metastases, or alcoholism. Also, history of loss of consciousness or transient ischemic attack within 12 months of enrollment (day 1 visit). Drugs may not be used which are known to decrease the seizure threshold

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

apalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. John Davis
• Organization: The University of Texas MD Anderson Cancer Center

johndavis@mdanderson.org

(713) 792-3250

Study Officials

• John W Davis

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: January 26, 2018
• Study Start: March 22, 2018
• Primary Completion: October 3, 2024
• Study Completion: March 30, 2026
• Last Updated: March 19, 2026
• Results First Posted: July 3, 2025

Record last verified: 2026-03

Locations

US (1)