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OpenTrials
Completed

NCT Number: NCT01091103

Determine Effect of Enzalutamide (MDV3100) on the Androgen Signaling Pathway in Correlation With the Anti-tumor Effects of Enzalutamide

This study is being conducted to determine the effect of enzalutamide on the androgen signaling pathway in correlation with the anti-tumor effects of enzalutamide to identify potential predictors of response or resistance to therapy.

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Key information

Conditions

Metastatic Progressive Castration-resistant Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

MD Anderson Cancer Center

Houston, Texas, 77303, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed prostate cancer
  • Presence of metastatic disease to the bone
  • Ongoing androgen deprivation therapy

Exclusion criteria

  • Severe concurrent disease
  • Metastases in the brain

Treatment and study plan

Enzalutamide

Drug

Other names: MDV3100

Primary outcomes

  1. Change From Baseline in Bone Marrow Testosterone

    Time frame: Baseline, Week 9

    Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit.

    Assessment of intratumoral testosterone was assessed by liquid chromatography mass spectrometry.

  2. Change From Baseline in Bone Marrow Dihydrotestosterone

    Time frame: Baseline, Week 9

    Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit.

    Assessment of intratumoral dihydrotestosterone was assessed by liquid chromatography mass spectrometry.

  3. Change From Baseline in Bone Marrow Testosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status

    Time frame: Baseline, Week 9

    Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral testosterone was assessed by liquid chromatography mass spectrometry.

    Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.

    The change from baseline in bone marrow testosterone levels at Week 9 was correlated with PSA response status at Week 9.

  4. Change From Baseline in Bone Marrow Dihydrotestosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status

    Time frame: Baseline, Week 9

    Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral dihydrotestosterone was assessed by liquid chromatography mass spectrometry.

    Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.

    The change from baseline in bone marrow dihydrotestosterone levels at Week 9 was correlated with PSA response status at Week 9.

Secondary outcomes

  1. Percentage of Participants at Week 9 With a Response in Prostate-Specific Antigen (PSA)

    Time frame: Baseline, Week 9

    Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.

  2. Median Time to Study Drug Discontinuation

    Time frame: Duration of study treatment through the data cutoff, up to 3 years.

    Exposure to study drug through the data cutoff of 26AUG2011 only. Fifteen participants (25.0%) were still on study drug as of the data cut-off date and were censored at this date.

  3. Change From Baseline in Urinary N-Telopeptide

    Time frame: Baseline, Week 5

    Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 5.

  4. Change From Baseline in Urinary N-Telopeptide

    Time frame: Baseline, Week 9

    Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 9.

  5. Change From Baseline in Urinary N-Telopeptide

    Time frame: Baseline, Week 17

    Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 17.

  6. Change From Baseline in Urinary N-Telopeptide

    Time frame: Baseline, Week 25

    Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 25.

  7. Change From Baseline in Urinary N-Telopeptide

    Time frame: Baseline, Week 33

  8. Change From Baseline in Urinary N-Telopeptide

    Time frame: Baseline, Week 41

    Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 41.

  9. Change From Baseline in Urinary N-Telopeptide

    Time frame: Baseline, Week 49

    Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 49.

  10. Change From Baseline in Urinary N-Telopeptide

    Time frame: Baseline, Week 57

    Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 57.

  11. Change From Baseline in Urinary N-Telopeptide

    Time frame: Baseline, Week 65

    Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 65.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Astellas Pharma Inc
  • Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

Registry information

Official study title

A Study Of Continuous Oral Dosing Of A Novel Antiandrogen Mdv3100, In Castration-resistant Bone Metastatic Prostate Cancer Patients Evaluating The Tumor Micro-enviroment

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Mar 23, 2010
Registry last updated
Oct 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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