Metastatic Progressive Castration-resistant Prostate CancerPhase 2NCT01091103

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

A Phase 2 study testing Enzalutamide in people with Metastatic Progressive Castration-resistant Prostate Cancer, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Metastatic Progressive Castration-resistant Prostate Cancer
What is being tested?: Enzalutamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 18 Feb 2010to 31 Aug 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

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

Who cannot join

Severe concurrent disease
Metastases in the brain

Trial locations and contacts

1 site in 1 country.

United States1 site

MD Anderson Cancer Center
Houston, Texas, 77303

Other trials in United States

About this study

Official 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

Conditions: Metastatic Progressive Castration-resistant Prostate Cancer
Being tested: Enzalutamide

What participants receive

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

EnzalutamideDrug
Also called MDV3100

Study groups in NCT01091103
Study group	Role	What they receive
Enzalutamide	Experimental	Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth. Study drug treatment continued until disease progression, unacceptable toxicity, or withdrawal. Receives: Drug: Enzalutamide

What is being measured

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

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

Secondary outcomes (11)

Percentage of Participants at Week 9 With a Response in Prostate-Specific Antigen (PSA)
Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.
Measured: Baseline, Week 9
Median Time to Study Drug Discontinuation
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.
Measured: Duration of study treatment through the data cutoff, up to 3 years.
Change From Baseline in Urinary N-Telopeptide
Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 5.
Measured: Baseline, Week 5
Change From Baseline in Urinary N-Telopeptide
Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 9.
Measured: Baseline, Week 9
Change From Baseline in Urinary N-Telopeptide
Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 17.
Measured: Baseline, Week 17
Change From Baseline in Urinary N-Telopeptide
Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 25.
Measured: Baseline, Week 25
Change From Baseline in Urinary N-Telopeptide
Measured: Baseline, Week 33
Change From Baseline in Urinary N-Telopeptide
Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 41.
Measured: Baseline, Week 41
Change From Baseline in Urinary N-Telopeptide
Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 49.
Measured: Baseline, Week 49
Change From Baseline in Urinary N-Telopeptide
Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 57.
Measured: Baseline, Week 57
Change From Baseline in Urinary N-Telopeptide
Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 65.
Measured: Baseline, Week 65

Timeline

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

18 Feb 201031 Aug 2013

First posted23 Mar 2010 (estimated)
Study start18 Feb 2010
Primary completion29 Feb 2012
Study completion31 Aug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Metastatic Progressive Castration-resistant Prostate CancerStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01091103
Sponsor's protocol ID: CRPC-MDA-1
Other IDs: C3431017
Status last verified: Oct 2018
First submitted: 19 Mar 2010
Last updated: 23 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Efstathiou E, Titus M, Wen S, Hoang A, Karlou M, Ashe R, Tu SM, Aparicio A, Troncoso P, Mohler J, Logothetis CJ. Molecular characterization of enzalutamide-treated bone metastatic castration-resistant prostate cancer. Eur Urol. 2015 Jan;67(1):53-60. doi: 10.1016/j.eururo.2014.05.005. Epub 2014 May 29.
PubMed 24882673

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT01091103
Acronym / sponsor ID: CRPC-MDA-1
Conditions: Metastatic Progressive Castration-resistant Prostate Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: Astellas Pharma Inc, Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Study start: 18 Feb 2010 (actual)
Primary completion: 29 Feb 2012 (actual)
Study completion: 31 Aug 2013 (actual)
First posted: 23 Mar 2010 (estimated)
Results: Posted 17 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Enzalutamide	Experimental	Drug: EnzalutamideParticipants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth. Study drug treatment continued until disease progression, unacceptable toxicity, or withdrawal.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

Severe concurrent disease
Metastases in the brain

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EnzalutamideAlso: MDV3100	Drug	Enzalutamide

Primary outcome

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.
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.
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.
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.

11 secondary outcomes

Percentage of Participants at Week 9 With a Response in Prostate-Specific Antigen (PSA)
Time frame: Baseline, Week 9
Median Time to Study Drug Discontinuation
Time frame: Duration of study treatment through the data cutoff, up to 3 years.
Change From Baseline in Urinary N-Telopeptide
Time frame: Baseline, Week 5
Change From Baseline in Urinary N-Telopeptide
Time frame: Baseline, Week 9
Change From Baseline in Urinary N-Telopeptide
Time frame: Baseline, Week 17
Change From Baseline in Urinary N-Telopeptide
Time frame: Baseline, Week 25
Change From Baseline in Urinary N-Telopeptide
Time frame: Baseline, Week 33
Change From Baseline in Urinary N-Telopeptide
Time frame: Baseline, Week 41
Change From Baseline in Urinary N-Telopeptide
Time frame: Baseline, Week 49
Change From Baseline in Urinary N-Telopeptide
Time frame: Baseline, Week 57
Change From Baseline in Urinary N-Telopeptide
Time frame: Baseline, Week 65

Results and safety

Results posted to the registry on 17 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enzalutamide	60	56

Primary outcome: Change From Baseline in Bone Marrow Testosterone

Time frame: Baseline, Week 9. Mean (Standard Deviation). Unit: ng/mL

Measure	Enzalutamide n = 31
Value	0.05 (0.072)

Population analysed: Participants who received any amount of enzalutamide and had bone marrow testosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required.

Primary outcome: Change From Baseline in Bone Marrow Dihydrotestosterone

Time frame: Baseline, Week 9. Mean (Standard Deviation). Unit: ng/mL

Measure	Enzalutamide n = 31
Value	0.00 (0.022)

Population analysed: Participants who received any amount of enzalutamide and had bone marrow dihydrotestosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required.

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

Time frame: Baseline, Week 9. Mean (Standard Deviation). Unit: ng/mL

Measure	Enzalutamide, PSA Responders at Week 9 n = 13	Enzalutamide, PSA Non-Responders at Week 9 n = 18
Value	0.05 (0.107)	0.05 (0.034)

Enzalutamide, PSA Responders at Week 9 vs Enzalutamide, PSA Non-Responders at Week 9: p = 0.9427, t-test, 2 sided

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

Time frame: Baseline, Week 9. Mean (Standard Deviation). Unit: ng/mL

Measure	Enzalutamide, PSA Responders at Week 9 n = 13	Enzalutamide, PSA Non-Responders at Week 9 n = 18
Value	-0.01 (0.034)	0.00 (0.000)

Enzalutamide, PSA Responders at Week 9 vs Enzalutamide, PSA Non-Responders at Week 9: p = 0.3370, t-test, 2 sided

11 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enzalutamide	13 of 60 (21.7%)	59 of 60 (98.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24882673Efstathiou E, Titus M, Wen S, Hoang A, Karlou M, Ashe R, Tu SM, Aparicio A, Troncoso P, Mohler J, Logothetis CJ. Molecular characterization of enzalutamide-treated bone metastatic castration-resistant prostate cancer. Eur Urol. 2015 Jan;67(1):53-60. doi: 10.1016/j.eururo.2014.05.005. Epub 2014 May 29.

Related trials for Metastatic Progressive Castration-resistant Prostate Cancer

Active, not recruitingPhase 4
RADIANT: A Study of Radium-223 Dichloride (Xofigo) vs Enzalutamide or Abiraterone (ARPIs, Androgen Receptor Pathway Inhibitors) in Patients With Prostate Cancer That Has Spread to the Bones (mCRPC, Metastatic Castration-Resistant Prostate Cancer)
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Active, not recruitingPhase 2
An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC
Metastatic Castration Resistant Prostate Cancer (mCRPC)
RecruitingPhase 2
Safety, Efficacy and Pharmacokinetics of TT00420 Tablets Combined With Novel Endocrine Therapy in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)
Prostate Cancer (CRPC)
RecruitingPhase 1/2
An Open-label Dose Escalation and Expansion, Followed by a Phase II Study of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer (mCRPC) (TulmiSTAR-01)
Progressive Metastatic Castrate Resistant Prostate Cancer
Active, not recruitingPhase 1/2
Combining Ipilimumab With Abiraterone Acetate Plus Prednisone in Chemotherapy and Immunotherapy-naïve Patients With Progressive Metastatic Castration-resistant Prostate Cancer
Prostate Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

Medical Monitor study director

Medivation, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enzalutamide in people with Metastatic Progressive Castration-resistant Prostate Cancer, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Bone Marrow Testosterone (time frame: Baseline, Week 9). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01091103, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.