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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Enzalutamide/Leuprolide +/- Abiraterone/Pred in Prostate

Overview

Status
Completed
Phase
Phase 2
Enrollment
75 participants (actual)
Sponsor
Dana-Farber Cancer Institute · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Oct 2014
Primary completion
Jan 2018
Completion
Dec 2021
First posted
20 Oct 2014 (estimated)
Last update posted
19 Apr 2022
Conditions
Prostate Adenocarcinoma · Prostate Cancer · High Risk Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142016201820202022
  1. Ph 2

    Enzalutamide/Leuprolide +/- Abiraterone/Pred in Prostate

    NCT02268175

    Oct 2014 to Dec 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study is comparing the effectiveness of enzalutamide with or without abiraterone acetate for men with high-risk, localized prostate cancer.

Interventions

  • EnzalutamideDrug
  • Abiraterone AcetateDrug
  • PrednisoneDrug
  • Leuprolide AcetateDrug

Arms2

  • Experimental

    ARM 1

    Participants will be randomized in a 2:1 ratio to neoadjuvant treatment (ARM 1) or (ARM 2). Participants will receive the assigned study treatment per cycle * Enzalutamide- Once daily at prespecified dose, orally * Abiraterone Acetate- Once daily at prespecified dose, orally * Prednisone-Once daily at prespecified dose, orally * Leuprolide Acetate-Intermuscular injection at prespecified dose and duration

  • Experimental

    ARM 2

    Participants will be randomized in a 2:1 ratio to neoadjuvant treatment (ARM 1) or (ARM 2). Participants will receive the assigned study treatment per cycle. * Enzalutamide- once daily at prespecified dose, orally * Leuprolide Acetate- Intermuscular injection at prespecified dose and duration

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of Participants With Pathologic Complete Response (pCR) or Minimal Residual Disease (MRD)

    Time frame · after RP approximately 24 weeks from study entry

    Registry description

    pCR is defined as the absence of morphologically identifiable carcinoma in the radical prostatectomy (RP) specimen. MRD is defined as the largest cross-sectional dimension of residual tumor measuring \</= 0.5 cm. If the tumor is multifocal, the size of the largest focus will be used to determine the size of the residual tumor.

Secondary outcomes(4)
  1. Participants With Pathologic Complete Response (pCR)

    Time frame · after RP approximately 24 weeks from study entry

    Registry description

    pCR is defined as the absence of morphologically identifiable carcinoma in the radical prostatectomy (RP) specimen.

  2. Residual Cancer Burden (RCB)

    Time frame · after RP approximately 24 weeks from study entry

    Registry description

    RCB was analyzed using radical prostatectomy (RP) tissue. The largest area of tumor was measured by ruler and the longest tumor dimension in this area was used as the dimension for calculation.

  3. Positive Surgical Margin Status

    Time frame · after RP approximately 24 weeks from study entry

    Registry description

    Participants were classified by presence or absence of positive surgical margins defined as margins, which are the edges of the removed tumor, that show some cancer cells.

  4. Median Prostate Specific Antigen (PSA) Nadir

    Time frame · PSA was assessed at baseline and every cycle during neoadjuvant therapy (up to 24 weeks).

    Registry description

    PSA nadir is the lowest PSA level recorded during neoadjuvant therapy.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· after RP approximately 24 weeks from study entry

Percentage of Participants With Pathologic Complete Response (pCR) or Minimal Residual Disease (MRD)

GroupValue (percentage of participants)
ARM 130
ARM 216
Secondary and other outcome results(4)
Secondary outcomeCount of participants· after RP approximately 24 weeks from study entry

Participants With Pathologic Complete Response (pCR)

GroupValue (Participants)
ARM 15
ARM 22
Secondary outcomeMedian· after RP approximately 24 weeks from study entry

Residual Cancer Burden (RCB)

GroupValue (cm)
ARM 10.03
ARM 20.05
Secondary outcomeCount of participants· after RP approximately 24 weeks from study entry

Positive Surgical Margin Status

GroupValue (Participants)
ARM 141
ARM 222
Secondary outcomeMedian· PSA was assessed at baseline and every cycle during neoadjuvant therapy (up to 24 weeks).

Median Prostate Specific Antigen (PSA) Nadir

GroupValue (ng/mL)
ARM 10.03
ARM 20.02

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
ARM 1Enzalutamide: 160 mg (four 40 mg capsules), oral, once daily, 28 days (4 weeks) 6 cycles maximum. Abiraterone Acetate: 1000 mg (four 250 mg tablets), oral, once daily, 28 days (4 weeks) 6 cycles maximum. Prednisone: 5 mg, oral, once daily, 28 days (4 weeks) 6 cycles maximum. Leuprolide Acetate: Either 7.5 mg monthly or 22.5 mg every three months, Intramuscular, monthly or every three months.0 / 503 / 5050 / 50
ARM 2Enzalutamide: 160 mg (four 40 mg capsules), oral, once daily, 28 days (4 weeks) 6 cycles maximum. Leuprolide Acetate: Either 7.5 mg monthly or 22.5 mg every three months, Intramuscular, monthly or every three months.0 / 251 / 2525 / 25

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2019

Evaluation of Intense Androgen Deprivation Before Prostatectomy: A Randomized Phase II Trial of Enzalutamide and Leuprolide With or Without Abiraterone.

McKay et al. 2019Journal of clinical oncology : official journal of the American Society of Clinical Oncologycited by 114

PMID 30811282PMC7051849DOI 10.1200/jco.18.01777PUB-30811282

Rights unknown
Source link

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedLin HM, Yang X, Centenera MM, Huynh K, Giles C, Dehairs J, Swinnen JV, Hoy AJ, Meikle PJ, Butler LM, Taplin ME, Horvath LG. Circulating Lipid Profiles Associated With Resistance to Androgen Deprivation Therapy in Localized Prostate Cancer. JCO Precis Oncol. 2024 Jul;8:e2400260. doi: 10.1200/PO.24.00260. PMID 39074346

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male greater than or equal 18 years of age. * Histologically confirmed adenocarcinoma of the prostate without histological variants (including overt neuroendocrine differentiation, small cell neuroendocrine carcinoma features, sarcomatoid features, pure ductal adenocarcinoma, squamous or transitional cell carcinoma). * Must have tissue available from the pre-treatment diagnostic biopsy (tissue blocks if possible; if not possible, 10 unstained slides from each positive core sample for a total of 30 slides). * Must have three core biopsies involved with cancer (a minimum of 6 core biopsies must be obtained). Prostate biopsy must be within three months from screening. * Participants must have the following features: * Intermediate-risk disease defined as Gleason 4+3=7 disease OR * High-risk disease defined as Gleason 8-10 OR PSA \> 20 ng/dL OR T3 disease (by prostate MRI) * No evidence of metastatic or nodal disease as determined by radionuclide bone scans CT/MRI. * Participants must be candidates for RP and considered surgically resectable by urologic evaluation. * ECOG performance status 0 to 1 (Appendix A). * Participants must have normal organ and marrow function as defined below: * WBC ≥ 3,000/mcL * ANC ≥ 1,500/mcL * Platelets ≥ 100,000/mcL * Serum potassium ≥ 3.5 mmol/L * AST, ALT, and total bilirubin ≤ 1.5 x Institutional ULN * Calculated creatinine clearance ≥ 60 mL/min * PTT ≤ 60, INR ≤ 1.5 x Institutional ULN unless on warfarin therapy (investigator would need to determine if safe for participant to stop warfarin prior to biopsy and warfarin therapy) * Controlled blood pressure defined as a systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg on no more than three anti-hypertensive agents. Drug formulations containing two or more anti-hypertensive agents will be counted based on the number of active agents in each formulation. Exclusion Criteria: * Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens (including first-generation antiandrogens, enzalutamide, ARN-509 and others), CYP17 inhibitors (including abiraterone, TAK-700, galeterone, ketoconazole, and others), estrogens, LHRH agonist/antagonists. Prior therapy with 5α-reductace inhibitors is allowed. LHRH therapy allowed if begun within 4 weeks of day 1. * Prior chemotherapy, radiation therapy, or immunotherapy for prostate cancer. * Prior systemic treatment with an azole drug within four weeks of screening visit. * Hypogonadism or severe androgen deficiency as defined by screening serum testosterone \< 200 ng/dL. * Clinically significant cardiovascular disease including: * Acute coronary syndrome within 6 months of screening visit; * Hypotension defined as a systolic blood pressure \< 86 mmHg; * Bradycardia defined as a heart rate of \< 50 beats per minute, unless pharmaceutically induced and thus reversible (i.e. beta blockers); * Uncontrolled angina (requiring escalating doses of nitrates) within 3 months of screening visit; * Congestive heart failure NYHA Class III or IV or subjects with a history of congestive heart failure NYHA Class III or IV, unless screening ECHO results in left ventricular ejection fraction that ≥ 45%; * History of clinically significant ventricular arrhythmias (e.g. ventricular tachycardia, ventricular fibrillation, torsades de pointes); * Prolonged corrected QT interval by the Fridericia correction formula (QTcF) on screening EKG \> 470 msec; * History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place; * History of seizure or any condition or concurrent medication that may predispose to seizure. * Thromboembolism within 6 months of screening visit. * Severe hepatic impairment (Child-Pugh Class C). * Active or symptomatic viral hepatitis or chronic liver disease. * History of pituitary or adrenal dysfunction. * GI disorders which may interfere with the absorption of the study drug. * Pre-existing condition that warrants long-term corticosteroid use. * Concomitant use of medications that may alter pharmacokinetics of abiraterone or enzalutamide. * Individuals with a history of a different malignancy are ineligible except for the following circumstances: 1) individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy, or 2) individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: non-muscle invasive bladder cancer, basal cell or squamous cell carcinoma of the skin. * Major surgery or radiation therapy within 30 days of screening.

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