ClinicalTrials.gg
CompletedNCT03279250Updated Aug 10, 2022Results posted

Apalutamide and Gonadotropin-Releasing Hormone Analog With or Without Abiraterone Acetate in Treating Participants With Prostate Cancer

A Phase 2 interventional study of Abiraterone Acetate and Apalutamide in Prostate Adenocarcinoma, Stage IIB Prostate Cancer AJCC v8 and Stage IIC Prostate Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-10.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

This phase II trial studies how well apalutamide and gonadotropin-releasing hormone analog with or without abiraterone acetate work in treating participants with prostate cancer prior to surgery. Apalutamide and abiraterone acetate may stop the growth of cancer cells either by killing the cells or by blocking some of the enzymes needed for cell growth. Hormone therapy, using gonadotropin-releasing hormone analog, may fight prostate cancer by lowering the amount of testosterone the body makes. Giving apalutamide, gonadotropin-releasing hormone analog, and abiraterone acetate may work better in treating participants with prostate cancer.

Read the detailed description

PRIMARY OBJECTIVES:

I. To assess the rate of pathologic stage =\< pT2N0 at prostatectomy for Group A (gonadotropin-releasing hormone analog [luteinizing hormone releasing hormone agonist (LHRHa)] plus apalutamide 240 mg orally [PO] daily for 6 months as preoperative therapy) and Group B (LHRHa plus apalutamide 240 mg PO daily plus abiraterone acetate 1000 mg PO daily and prednisone 5 mg PO once daily [QD] for 6 months as preoperative therapy).

SECONDARY OBJECTIVES:

I. To assess the tumor epithelium volume following treatment in groups A and B. II. To assess the rate of positive surgical margins in Group A and Group B. III. To assess the time to prostate specific antigen (PSA) recurrence (TTRPSA). IV. To assess the safety profile of the two treatment arms (apalutamide with and without abiraterone acetate and low dose prednisone) for six months in a preoperative setting.

EXPLORATORY OBJECTIVES:

I. Assessment of the steroid hormone metabolome in blood plasma and tissue by liquid chromatography tandem mass spectrometry.

II. Assessment of androgen signaling (canonical and non-canonical) and candidate pathways of resistance to androgen signaling inhibition by protein and ribonucleic acid (RNA) analysis.

III. Assessment of citrate intracellular tricarboxylic acid cycle (TCA) metabolite concentrations with liquid chromatography-tandem mass spectrometry (LCMS/MS).

IV. Proportion of patients who achieve pathological complete response (CR). V. Hyperpolarized 1-13C-pyruvate imaging at study entry and at 3 months in Arm A and Arm B.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM A: Participants receive gonadotropin-releasing hormone analog (leuprolide, goserelin, or triptorelin as determined by treating physician) intramuscularly (IM) once every 3 months and apalutamide PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy.

ARM B: Participants receive gonadotropin-releasing hormone analog and apalutamide as in arm A, abiraterone acetate PO QD, and prednisone PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy.

After completion of study treatment, participants are followed for 4 weeks.

02

Conditions studied

  • Prostate Adenocarcinoma
  • Stage IIB Prostate Cancer AJCC v8
  • Stage IIC Prostate Cancer AJCC v8
  • Stage IIIA Prostate Cancer AJCC v8
  • Stage IIIC Prostate Cancer AJCC v8

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03

In context

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

This study's enrollment of 86 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.

Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients must have or cytologically confirmed adenocarcinoma of the prostate with no histological variants (such as small cell, sarcomatoid, pure ductal cancer, transitional cell carcinoma).
  • Patients may have received one prior depot injection of LHRH agonist or LHRH antagonist (degarelix) within 30 days prior to study entry. Patients who have received any other prior hormonal therapy or any chemotherapy for prostate cancer will be excluded. (Patients who have discontinued finasteride or dutasteride or testosterone supplement for at least 2 weeks will be allowed to enroll).
  • Be willing/able to adhere to the prohibitions and restrictions specified in this protocol.
  • Have signed an document indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study.
  • Written authorization for use and release of health and research study information has been obtained.
  • Pathology review at Monroe Dunaway (MD) Anderson (Note: if patient's prostate was not read at MD Anderson, it must be reviewed at the study site to confirm eligibility).
  • Prostate biopsy. If previous biopsy has been performed within 3 months of screening, second biopsy procedure will not be required, if archival biopsies and at least one formalin fixed paraffin embedded biopsy tissue block containing tumor is available.
  • The following tumor stage and Gleason scores: a) clinical >= stage T1c/T2 tumor with Gleason score >=8 b) clinical stage >= T2b tumor with Gleason score >= 7 and PSA > 10 ng/ml.
  • Serum testosterone > 150 ng/dL. For patients treated up to 1 month of LHRH agonist, a testosterone measurement prior to the LHRH treatment will be used to determine eligibility, and must have been > 150 ng/dL. If no testosterone level is available from before LHRHa injection up to 30 days prior to study entry, the patient will be ineligible.
  • Patient is suitable for prostatectomy.
  • No evidence of disease as determined by imaging procedures.
  • (ECOG) performance status of 0 or 1.
  • >= 9.0 g/dL independent of transfusion.
  • count >= 100,000/uL.
  • Absolute peripheral (ANC) > 1,000.
  • >= 50 mL/min.
  • Serum potassium >= 3.5 mmol/L.
  • Serum =\< 1.5 x (ULN).
  • (ALT) and aspartate aminotransferase (AST) =\< 2.5 x ULN.
  • Serum albumin >= 3 g/dl.
  • Able to swallow the study drug whole as a tablet.
  • Patients must have 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 if he is having sex with a woman of 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.
  • Willing to take abiraterone acetate on an empty stomach; no food should be consumed at least two hours before and for at least one hour after the dose of abiraterone acetate is taken.
  • of greater than 12 months.

Exclusion criteria

Exclusion Criteria:

  • Patients who have had any prior chemotherapy or radiotherapy for prostate cancer.
  • Patients who have had > 1 LHRH agonist or antagonist depot injection or received depot injection > 30 days before study entry.
  • Patients may not be receiving any other agents.
  • Patients may not be receiving the concomitant administration of any systemic therapy, biologic therapy, or other agents with anti-tumor activity against prostate cancer while the patients are on study.
  • Patients with known prostate cancer.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to leuprolide acetate, abiraterone acetate, prednisone or apalutamide or other agents used in the study.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with apalutamide and abiraterone. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
  • Avoid concomitant strong inducers during abiraterone acetate treatment. If a strong CYP3A4 inducer must be co-administered, increase the abiraterone acetate dosing frequency.
  • Avoid co-administration of abiraterone acetate with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate.
  • Patients receiving medications known to lower the seizure threshold are ineligible unless discontinued or substituted at least 4 weeks prior to study entry. These include: 1) aminophylline/theophylline; 2) atypical antipsychotics (e.g., clozapine, olanzapine, risperidone, ziprasidone); 3) bupropion; 4) lithium; 5) pethidine; 6) phenothiazine antipsychotics (e.g., prochlorperazine (compazine), chlorpromazine, mesoridazine, thioridazine); 7) tricyclic and tetracyclic antidepressants (e.g., amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine).
  • Chronically uncontrolled hypertension, defined conventionally as consistent systolic pressures above 170 or diastolic pressures above 110 despite 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. (for example doctor's visit related stress i.e. "white coat syndrome".
  • Requirement for greater than the equivalent of 10 mg of prednisone daily for more than 2 weeks.
  • Poorly controlled diabetes defined by > 9.0 at screening.
  • Active or symptomatic viral hepatitis or chronic liver disease.
  • Known history of pituitary or adrenal dysfunction.
  • Other , 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.
  • Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or LHRH agonists/antagonists (Note: LHRH allowed if begun within 1 month of day 1).
  • Prior systemic treatment with an azole drug within four weeks of cycle 1 day 1.
  • Current enrollment in an investigational drug or device study or participation in such a study within 30 days of cycle 1 day 1.
  • Allergies, , or intolerance to prednisone, LHRH analog or of prednisone LHRH analog, abiraterone acetate and apalutamide.
  • Previous use of abiraterone acetate or other investigational CYP17 inhibitor (e.g., TAK-700).
  • Previous investigational antiandrogens (e.g., apalutamide, enzalutamide, BMS-641988).
  • Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study.
  • Patients unable to tolerate transrectal ultrasound.
  • Anti-androgens (steroidal or non-steroidal) such as cyproterone acetate, flutamide, nilutamide, bicalutamide, etc. other than assigned study drug unless given for =\< 4 weeks.
  • Estrogens, progestational agents such as megestrol, medroxyprogesterone, diethylstilbestrol (DES), cyproterone, spironolactone > 50 mg/kg, etc. unless discontinued at least two weeks prior to randomization.
  • Androgens such as testosterone, dehydroepiandrosterone (DHEA), etc. unless discontinued at least two weeks prior to randomization.
  • Herbal products that may decrease PSA levels (e.g., saw palmetto) unless discontinued two weeks prior to randomization.
  • Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use .
  • Severe hepatic impairment ( Class C).
  • History of significant bleeding disorder unrelated to cancer, including: 1) diagnosed congenital bleeding disorders (e.g., von Willebrand's disease); 2) diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies) of screening visit; 3) history of gastrointestinal (GI) bleeding within 3 months of screening visit requiring >= 2 units packed red blood cells.
  • cardiovascular disease including: 1) myocardial infarction within 6 months of screening visit; 2) uncontrolled angina within 3 months of screening visit; 3) congestive heart failure (NYHA) class 3 or 4, or subjects with history of congestive heart failure NYHA class 3 or 4 in the past, or history of anthracycline or anthracenedione (mitoxantrone) treatment, unless a screening echocardiogram or multi-gated acquisition scan () performed within three months of the Screening visit results in a left ventricular ejection fraction that is >= 50%. 4) history of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsade de pointes). 5) prolonged interval by the Fridericia correction formula (QTcF) on the screening (ECG) > 470 msec. 6) history of Mobitz II second degree or third degree heart block without a permanent pacemaker in place. 7) hypotension (systolic blood pressure \< 86 mmHg or bradycardia with a heart rate of \< 50 beats per minute on the screening ECG, unless pharmaceutically induced and thus reversible (i.e. beta blockers).
Terms in these criteria, in plain language(30)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
86 participants (actual)

Study arms

  • Experimental
    Arm A (LHRHa, apalutamide)

    Participants receive gonadotropin-releasing hormone analog (leuprolide, goserelin, or triptorelin as determined by treating physician) IM once every 3 months and apalutamide PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy.

    Drug: Apalutamide · Biological: Gonadotropin-releasing Hormone Analog · Procedure: Radical Prostatectomy

  • Experimental
    Arm B (LHRHa, apalutamide, abiraterone acetate)

    Participants receive gonadotropin-releasing hormone analog and apalutamide as in arm A, abiraterone acetate PO QD, and prednisone PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy.

    Drug: Abiraterone Acetate · Drug: Apalutamide · Biological: Gonadotropin-releasing Hormone Analog · Drug: Prednisone · Procedure: Radical Prostatectomy

Interventions

  • Given PO

    Also known as: CB7630, Yonsa, Zytiga

  • Given PO

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

  • Given IM

    Also known as: GnRH Agonist, GnRH Analog, Gonadotropin-Releasing Hormone Agonist, Gonadotropin-Releasing Hormone Analogue, LH-RH agonist, LH-RH Analogs, LHRH Agonist, luteinizing hormone-releasing hormone agonist, Luteinizing Hormone-Releasing Hormone Analog

  • Given PO

    Also known as: .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone

  • ProcedureRadical Prostatectomy

    Undergo radical prostatectomy

    Also known as: Prostatovesiculectomy

06

What researchers measure

Primary outcomes

  1. The Number of Participants With Rate of Pathologic Stage =< pT2N0 at Prostatectomy

    The study will provide a point estimate and 95% confidence interval of the proportion of patients with pathologic stage =\< pT2N0 at prostatectomy for each arm. Patient characteristics will be summarized using descriptive statistics for each arm.

    Time frame: At the time of radical prostatectomy

Secondary outcomes

  1. Number of Participants With Incidence of Adverse Events

    Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Incidence of serious adverse events and 95% confidence interval will be provided overall as well as for each major affected organ category.

    Time frame: From screening up to 4 weeks post-surgery, an average of 7 months

  2. Tumor Epithelium Volume in the Surgical Specimen

    Tumor volume will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Secondary categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.

    Time frame: At the time of radical prostatectomy

  3. Assessment of Positive Surgical Margins in the Surgical Specimen

    Presence of positive surgical margins will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Secondary categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.

    Time frame: At the time of radical prostatectomy

  4. Time to Prostate Specific Antigen Recurrence (TTRPSA)

    TTRPSA will be summarized by Kaplan-Meier estimates and confidence intervals. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Secondary categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.

    Time frame: From the date of randomization up to 4 weeks post-surgery

Other outcomes

  1. Assessment of Steroid Hormone Metabolome in Blood Plasma and Tissue

    Steroid hormone metabolome in blood plasma and tissue will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Exploratory categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.

    Time frame: At radical prostatectomy

  2. Assessment of Protein and Ribonucleic Acid (RNA) Analysis Results

    Assessment of protein and RNA analysis results will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Exploratory categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.

    Time frame: At radical prostatectomy

  3. Citrate Intracellular Tricarboxylic Acid (TCA) Cycle Metabolite Concentrations

    Citrate intracellular TCA cycle metabolite concentrations will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Exploratory categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.

    Time frame: At radical prostatectomy

  4. Pathological Response

    Pathological response will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Exploratory categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.

    Time frame: Up to 4 weeks post-surgery

  5. Hyperpolarized 1-13C-pyruvate Imaging Results

    Hyperpolarized 1-13C-pyruvate imaging results will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Exploratory categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.

    Time frame: Up to 4 weeks post-surgery

07

Results

Posted Aug 10, 2022

Participant flow

Participant flow — Overall Study
MilestoneArm A (LHRHa, Apalutamide)Arm B (LHRHa, Apalutamide, Abiraterone Acetate)
Started3434
Completed3434
Not completed00

Outcome measures

PrimaryThe Number of Participants With Rate of Pathologic Stage =< pT2N0 at Prostatectomy

The study will provide a point estimate and 95% confidence interval of the proportion of patients with pathologic stage =\< pT2N0 at prostatectomy for each arm. Patient characteristics will be summarized using descriptive statistics for each arm.

Time frame:
At the time of radical prostatectomy
Reported as:
Count of participants · Participants
The Number of Participants With Rate of Pathologic Stage =< pT2N0 at Prostatectomy
ParticipantsArm A (LHRHa, Apalutamide)Arm B (LHRHa, Apalutamide, Abiraterone Acetate)
The Number of Participants With Rate of Pathologic Stage =< pT2N0 at Prostatectomy1312
SecondaryNumber of Participants With Incidence of Adverse Events

Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Incidence of serious adverse events and 95% confidence interval will be provided overall as well as for each major affected organ category.

Time frame:
From screening up to 4 weeks post-surgery, an average of 7 months
Reported as:
Count of participants · Participants
Number of Participants With Incidence of Adverse Events
ParticipantsArm A (LHRHa, Apalutamide)Arm B (LHRHa, Apalutamide, Abiraterone Acetate)
Serious12
Non Serious3434
SecondaryTumor Epithelium Volume in the Surgical Specimen

Tumor volume will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Secondary categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.

Time frame:
At the time of radical prostatectomy

No measurements were reported for this outcome.

SecondaryAssessment of Positive Surgical Margins in the Surgical Specimen

Presence of positive surgical margins will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Secondary categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.

Time frame:
At the time of radical prostatectomy

No measurements were reported for this outcome.

SecondaryTime to Prostate Specific Antigen Recurrence (TTRPSA)

TTRPSA will be summarized by Kaplan-Meier estimates and confidence intervals. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Secondary categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.

Time frame:
From the date of randomization up to 4 weeks post-surgery

No measurements were reported for this outcome.

Other pre-specifiedAssessment of Steroid Hormone Metabolome in Blood Plasma and Tissue

Steroid hormone metabolome in blood plasma and tissue will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Exploratory categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.

Time frame:
At radical prostatectomy

Results for this outcome have not been posted.

Other pre-specifiedAssessment of Protein and Ribonucleic Acid (RNA) Analysis Results

Assessment of protein and RNA analysis results will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Exploratory categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.

Time frame:
At radical prostatectomy

Results for this outcome have not been posted.

Other pre-specifiedCitrate Intracellular Tricarboxylic Acid (TCA) Cycle Metabolite Concentrations

Citrate intracellular TCA cycle metabolite concentrations will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Exploratory categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.

Time frame:
At radical prostatectomy

Results for this outcome have not been posted.

Other pre-specifiedPathological Response

Pathological response will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Exploratory categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.

Time frame:
Up to 4 weeks post-surgery

Results for this outcome have not been posted.

Other pre-specifiedHyperpolarized 1-13C-pyruvate Imaging Results

Hyperpolarized 1-13C-pyruvate imaging results will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Exploratory categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.

Time frame:
Up to 4 weeks post-surgery

Results for this outcome have not been posted.

Adverse events

Collected over From screening up to 4 weeks post-surgery, an average of 7 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm A (LHRHa, Apalutamide)1/34 (2.9%)1/34 (2.9%)34/34 (100%)
Arm B (LHRHa, Apalutamide, Abiraterone Acetate)1/34 (2.9%)2/34 (5.9%)34/34 (100%)
Most frequent serious events
Most frequent serious events
EventArm A (LHRHa, Apalutamide)Arm B (LHRHa, Apalutamide, Abiraterone Acetate)
DehydrationMetabolism and nutrition disorders0/341/34
Atrial fibrillationCardiac disorders0/341/34
SyncopeNervous system disorders1/340/34
Most frequent other events
Showing 10 of 46
Most frequent other events
EventArm A (LHRHa, Apalutamide)Arm B (LHRHa, Apalutamide, Abiraterone Acetate)
Hot flashesVascular disorders31/3425/34
FatigueGeneral disorders30/3424/34
AnemiaBlood and lymphatic system disorders21/3415/34
HyperglycemiaMetabolism and nutrition disorders16/3413/34
Dry skinSkin and subcutaneous tissue disorders14/348/34
Cholesterol highInvestigations11/346/34
InsomniaPsychiatric disorders10/342/34
RashSkin and subcutaneous tissue disorders10/347/34
AST increaseInvestigations4/349/34
DizzinessNervous system disorders9/345/34

Baseline characteristics

Age, Continuous
Age, Continuous(years)Arm A (LHRHa, Apalutamide)Arm B (LHRHa, Apalutamide, Abiraterone Acetate)Total
Mean64 (54 to 75)62 (43 to 77)63 (43 to 77)
Sex: Female, Male
Sex: Female, Male(Participants)Arm A (LHRHa, Apalutamide)Arm B (LHRHa, Apalutamide, Abiraterone Acetate)Total
Female000
Male343468
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Arm A (LHRHa, Apalutamide)Arm B (LHRHa, Apalutamide, Abiraterone Acetate)Total
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Arm A (LHRHa, Apalutamide)Arm B (LHRHa, Apalutamide, Abiraterone Acetate)Total
United States343468
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Study locations

1 site
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in May 2021, 42 months.

Results were first posted in Aug 2022, 1 year 2 months after primary completion.

Of 610 non-industry phase 2 interventional studies under Prostatic Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 86. This study's 42 months is below that.

Counting every sponsor, half of 724 studies reached it within 53 months; a quarter within 34 and three quarters within 80.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 7, 2017
First posted
Sep 12, 2017
StartActual
Oct 13, 2017
Primary completionActual
May 11, 2021
CompletionActual
May 11, 2021
Results first posted
Aug 10, 2022
Last update
Aug 10, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03279250
Responsible party
Sponsor
First posted
Sep 12, 2017
Start date
Oct 13, 2017
Primary completion
May 11, 2021
Completion
May 11, 2021
Results posted
Aug 10, 2022
Last update
Aug 10, 2022

Study contacts

Christopher Logothetis
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Apalutamide · Gonadotropin-releasing Hormone Analog

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