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Prostate AdenocarcinomaPhase 2NCT03412396

Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy

A Phase 2 study testing Apalutamide, Quality-of-Life Assessment and Radical Prostatectomy in people with Prostate Adenocarcinoma and Stage IIB Prostate Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Apalutamide, Quality-of-Life Assessment and Radical Prostatectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUnited States
Study dates
22 Mar 2018to 30 Mar 2028
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN
  • Normal coagulation profile and no history of substantial non-iatrogenic bleeding diathesis
  • Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Single Arm Study of 6-Months Neoadjuvant Apalutamide Prior to Radical Prostatectomy in Intermediate Risk Patients to Reduce the Frequency of Pathologic Features That Drive Post-Operative Radiation Therapy

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine whether 6 months (24 weeks) of neoadjuvant apalutamide prior to prostatectomy for intermediate risk prostate cancer results in a reduction of aggregate pathologic risk features that drive post-operative radiotherapy recommendations from 35% to 15%.

SECONDARY OBJECTIVES:

  1. To determine the safety and tolerability of 6 months (24 weeks) neoadjuvant apalutamide followed by radical prostatectomy for intermediate risk prostate cancer.

II. To estimate the frequency of clinical complete responses and "near" complete responses (currently defined as < 6 mm total tumor volume).

III. To characterize the molecular features of the treated prostate cancers and link them to morphologic characterization.

IV. To measure the 3-5 year biochemical recurrence rate of treated patients as a baseline to inform a larger phase III trial.

OUTLINE:

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

After completion of study treatment, patients are followed up at 12 months.

Being tested
Apalutamide, Quality-of-Life Assessment, Radical Prostatectomy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApalutamideDrug

    Also called ARN 509, ARN-509, ARN509, Erleada

    Given PO

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Radical ProstatectomyProcedure or surgery

    Also called Prostatovesiculectomy

    Undergo radical prostatectomy

Study groups in NCT03412396
Study groupRoleWhat they receive
Treatment (apalutamide, radical prostatectomy)ExperimentalPatients 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.
Receives: Drug: Apalutamide; Other: Quality-of-Life Assessment; Procedure: Radical Prostatectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)

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

    Incidence of treatment emergent adverse events (TEAEs). All patients who receive any dose of apalutamide will be evaluable for safety.

    Measured: 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.

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

    The numbers of patients with <6 mm total tumor volume in their surgical specimens, assessed by study Pathologist.

    Measured: Assessed at time of surgical specimen microscopic evaluation

  3. Biochemical Recurrence Rate

    Number of patients who had a PSA value of equal of more than 0.2 ng/dL after surgery and through 3 years of follow up.

    Measured: From surgery through 3-year post-op follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2018
  2. Study start22 Mar 2018
  3. Primary completion3 Oct 2024
  4. Study completion30 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03412396
Sponsor's protocol ID
2015-0693
Other IDs
NCI-2018-00902, 2015-0693
Status last verified
Mar 2026
First submitted
19 Jan 2018
Last updated
22 Oct 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

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