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NCT01547299

Study of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer

Completed Phase 2 Results posted Last updated 23 October 2018
What this trial tests

Phase 2 trial testing Enzalutamide in Prostate Cancer in 52 participants. Completed in 30 November 2013.

Timeline
31 March 2012
Primary endpoint
30 November 2013
30 November 2013

Quick facts

Lead sponsorPfizer
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment52
Start date31 March 2012
Primary completion30 November 2013
Estimated completion30 November 2013
Sites4 locations across Canada, United States

Drugs / interventions tested

Conditions studied

Sponsor

Pfizer — full company profile →

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pathologic Complete Response Rate Primary · Day 180

Pathologic complete response rate was defined as percentage of participants with pathologic complete response. Pathologic complete response rate following triplet therapy (enzalutamide in combination with leuprolide and dutasteride) and enzalutamide alone when administered as neoadjuvant therapy for 180 days prior to prostatectomy in participants with localized prostate cancer. Pathologic complete response was defined as the absence of morphologically identifiable carcinoma in the prostatectomy specimen, as assessed by the local and central pathologist.

Local pathologist
GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride8.71.1 – 28.0
Enzalutamide0.00.0 – 13.7
Central pathologist
GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride4.30.1 – 21.9
Enzalutamide0.00.0 – 13.7
Percentage of Participants With Positive Surgical Margins Secondary · Day 180

To determine the percentage of participants with positive surgical margins at prostatectomy as assessed by the local and central pathologist. Surgical margin, also known as tumor free margin referred to the visible normal tissue or skin margin that was removed with the surgical excision of a tumor, growth, or malignancy. The margin was described as positive when the pathologist finds cancer cells at the edge of the tissue, suggesting that all of the cancer has not been removed.

Local pathologist
GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride4.30.1 – 21.9
Enzalutamide12.02.5 – 31.2
Central pathologist
GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride21.77.5 – 43.7
Enzalutamide16.04.5 – 36.1
Percentage of Participants With Extracapsular Extension: Local Review Secondary · Day 180

To determine the percentage of participants with extracapsular extension at prostatectomy as assessed by the local pathologist. Extracapsular extension was defined as prostate cancer cells when extended into the prostate capsule or outer lining of the prostate gland.

GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride26.110.2 – 48.4
Enzalutamide36.018.0 – 57.5
Percentage of Participants With Extracapsular Extension: Central Review Secondary · Day 180

To determine the percentage of participants with extracapsular extension at prostatectomy as assessed by the central pathologist. Extracapsular extension was defined as prostate cancer cells when extended into the prostate capsule or outer lining of the prostate gland.

GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride56.534.5 – 76.8
Enzalutamide70.848.9 – 87.4
Percentage of Participants With Positive Seminal Vesicles Secondary · Day 180

To determine the percentage of participants with positive seminal vesicles at prostatectomy as assessed by the local and central pathologist. Seminal vesicles or seminal glands, were defined as a pair of simple tubular glands located within the pelvis. They secrete fluid that partly composes the semen. Seminal vesicles with cancer cells in them were called positive seminal vesicles.

Local pathologist
GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride30.413.2 – 52.9
Enzalutamide36.018.0 – 57.5
Central pathologist
GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride30.413.2 – 52.9
Enzalutamide36.018.0 – 57.5
Percentage of Participants With Positive Lymph Nodes Secondary · Day 180

To determine the percentage of participants with positive lymph nodes at prostatectomy as assessed by the local and central pathologist. Lymph nodes were small clumps of immune cells that act as filters for the lymphatic system. Lymph nodes with cancer cells in them were called positive lymph nodes.

Local pathologist
GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride26.110.2 – 48.4
Enzalutamide4.00.1 – 20.4
Central pathologist
GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride26.110.2 – 48.4
Enzalutamide4.00.1 – 20.4
Prostate-Specific Antigen (PSA) Nadir Secondary · Day 195

To determine the effects on PSA as measured by the lowest post baseline PSA value prior to prostatectomy. Prostate-specific antigen (PSA) was a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA nadir was the participant's lowest observed post baseline PSA value.

GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride0.040.01 – 0.53
Enzalutamide0.510.02 – 8.80
Time to Prostate-Specific Antigen (PSA) Nadir Secondary · Day 195

To determine the effects on PSA as measured by the time to the lowest post baseline PSA value prior to prostatectomy. Prostate-specific antigen (PSA) was a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA nadir was the participant's lowest observed post baseline PSA value.

GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride5.092.79 – 6.44
Enzalutamide6.012.89 – 6.64
Percentage of Participants With Reduction in Prostate-Specific Antigen (PSA) Secondary · Day 195

To determine the effects on PSA as measured by the percentage of participants with PSA less than (\<) 0.2 nanogram per milliliter (ng/mL), and a 50 percent (%) and 90% decrease in PSA value prior to prostatectomy. Prostate-specific antigen (PSA) was a protein produced by normal, as well as malignant, cells of the prostate gland.

PSA < 0.2 ng/mL
GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride92.074.0 – 99.0
Enzalutamide29.613.8 – 50.2
50% decrease in PSA
GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride100.086.3 – 100.0
Enzalutamide100.087.2 – 100.0
90% decrease in PSA
GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride100.086.3 – 100.0
Enzalutamide63.042.4 – 80.6
Health-Related Quality of Life (HRQoL): Number of Participants With The Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Summary Score Secondary · Day 180

EPIC sexual domain was HRQoL instrument that measured the effects of prostate cancer treatment on a participant's sexual function and sexual satisfaction. Sexual domain summary score was measured on a scale ranged from 0 (worst) to 100 (best) with higher scores representing better sexual function and satisfaction. Best change from baseline category in EPIC sexual domain summary score ranged from worsened to improved where worsened indicated decrease of at least 1 minimally important difference, stable indicated changed by less than 1 minimally important difference and improved indicated increa

Worsened
GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride11
Enzalutamide10
Stable
GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride4
Enzalutamide6
Improved
GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride1
Enzalutamide0
Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Sexual Function Subscale Score Secondary · Day 180

EPIC sexual function subscale was HRQoL instrument that measured the effects of prostate cancer treatment on a participant's sexual function and sexual satisfaction. EPIC sexual function subscale was a component of sexual domain that was evaluated on a distinct set of questions. It was measured on a scale ranged from 0 (worst) to 100 (best) with higher scores representing better sexual function. Best change from baseline category in EPIC sexual function subscale score ranged from worsened to improved where worsened indicated decrease of at least 1 minimally important difference, stable indicat

Worsened
GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride11
Enzalutamide12
Stable
GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride4
Enzalutamide5
Improved
GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride0
Enzalutamide0
Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Sexual Bother Subscale Score Secondary · Day 180

EPIC sexual bother subscale was HRQoL instrument that measured the effects of prostate cancer treatment on a participant's sexual function and sexual satisfaction. EPIC sexual bother subscale was a component of sexual domain that was evaluated on a distinct set of questions. It was measured on a scale ranged from 0 (worst) to 100 (best) with higher scores representing less sexual bother and difficulty. Best change from baseline category in EPIC sexual bother subscale score ranged from worsened to improved where worsened indicated decrease of at least 1 minimally important difference, stable in

Worsened
GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride7
Enzalutamide5
Stable
GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride9
Enzalutamide7
Improved
GroupValue95% CI
Enzalutamide + Leuprolide + Dutasteride0
Enzalutamide4

Adverse events — posted to ClinicalTrials.gov

Time frame: From baseline to 30 days after the last dose of study drug, up to 210 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Enzalutamide + Leuprolide + Dutasteride
Serious: 3/25 (12%)
Deaths: —
Enzalutamide
Serious: 2/27 (7%)
Deaths: —

Serious adverse events (4 terms)

ReactionSystemEnzalutamide + Leuprolide …Enzalutamide
Postoperative ileusInjury, poisoning and procedural complications——
Pelvic abscessInfections and infestations——
Clostridial infectionInfections and infestations——
LymphoceleVascular disorders——
Other adverse events (55 terms — click to expand)

ReactionSystemEnzalutamide + Leuprolide …Enzalutamide
Hot flushVascular disorders——
FatigueGeneral disorders——
GynaecomastiaReproductive system and breast disorders——
InsomniaPsychiatric disorders——
Breast tendernessReproductive system and breast disorders——
Libido decreasedPsychiatric disorders——
Breast painReproductive system and breast disorders——
DiarrhoeaGastrointestinal disorders——
PollakiuriaRenal and urinary disorders——
Erectile dysfunctionReproductive system and breast disorders——
Incision site painInjury, poisoning and procedural complications——
Urinary incontinenceRenal and urinary disorders——
ConstipationGastrointestinal disorders——
NasopharyngitisInfections and infestations——
NauseaGastrointestinal disorders——
AnxietyPsychiatric disorders——
MyalgiaMusculoskeletal and connective tissue disorders——
HeadacheNervous system disorders——
HypertensionVascular disorders——
IncontinenceRenal and urinary disorders——
Memory impairmentNervous system disorders——
Restless leg syndromeNervous system disorders——
Decreased appetiteMetabolism and nutrition disorders——
HypokalaemiaMetabolism and nutrition disorders——
Nipple painReproductive system and breast disorders——
NocturiaRenal and urinary disorders——
SinusitisInfections and infestations——
Urinary tract infectionInfections and infestations——
AmnesiaNervous system disorders——
Dry skinSkin and subcutaneous tissue disorders——
Oestradiol increasedInvestigations——
Oedema peripheralGeneral disorders——
PyrexiaGeneral disorders——
ChillsGeneral disorders——
CoughRespiratory, thoracic and mediastinal disorders——
DepressionPsychiatric disorders——
DiverticulitisInfections and infestations——
HyperglycaemiaMetabolism and nutrition disorders——
Mental impairmentNervous system disorders——
Musculoskeletal painMusculoskeletal and connective tissue disorders——

Most-reported serious reactions: Postoperative ileus, Pelvic abscess, Clostridial infection, Lymphocele.

Data from ClinicalTrials.gov NCT01547299 adverse events section.

Sponsor's own description

The purpose of this study is to determine if enzalutamide is an effective therapy in treating localized prostate cancer prior to prostatectomy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Neoadjuvant Enzalutamide Prior to Prostatectomy.
    Montgomery B, Tretiakova MS, Joshua AM, Gleave ME, et al · · 2017 · cited 99× · PMID 28151719 · DOI 10.1158/1078-0432.ccr-16-1357
  2. Post prostatectomy outcomes of patients with high-risk prostate cancer treated with neoadjuvant androgen blockade.
    McKay RR, Montgomery B, Xie W, Zhang Z, et al · · 2018 · cited 53× · PMID 29263420 · DOI 10.1038/s41391-017-0009-6
  3. Androgen deprivation therapy as backbone therapy in the management of prostate cancer.
    Merseburger AS, Alcaraz A, von Klot CA. · · 2016 · cited 41× · PMID 27942220 · DOI 10.2147/ott.s117176
  4. Recent Advances in the Management of High-Risk Localized Prostate Cancer: Local Therapy, Systemic Therapy, and Biomarkers to Guide Treatment Decisions.
    McKay RR, Feng FY, Wang AY, Wallis CJD, et al · · 2020 · cited 36× · PMID 32412803 · DOI 10.1200/edbk_279459
  5. Enzalutamide as a second generation antiandrogen for treatment of advanced prostate cancer.
    Semenas J, Dizeyi N, Persson JL, Persson JL. · · 2013 · cited 33× · PMID 24009414 · DOI 10.2147/dddt.s45703
  6. Androgen deprivation therapy in castrate-resistant prostate cancer: how important is GnRH agonist backbone therapy?
    Merseburger AS, Hammerer P, Rozet F, Roumeguère T, et al · · 2015 · cited 26× · PMID 25261259 · DOI 10.1007/s00345-014-1406-2
  7. Targeting the androgen receptor in the management of castration-resistant prostate cancer: rationale, progress, and future directions.
    Leibowitz-Amit R, Joshua AM. · · 2012 · cited 26× · PMID 23355790 · DOI 10.3747/co.19.1281
  8. Enzalutamide: an evidence-based review of its use in the treatment of prostate cancer.
    Golshayan AR, Antonarakis ES. · · 2013 · cited 25× · PMID 23589709 · DOI 10.2147/ce.s34747

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