Trial · NCT02213107

Enzalutamide & Dutasteride/Finasteride as 1st Line Treatment for Patients =/> 65 Years Old With Prostate Cancer.

NCT02213107, Phase 2, Completed, University of Rochester; results first posted 2024-11-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Enzalutamide & Dutasteride/Finasteride as 1st Line Treatment for Patients =/> 65 Years Old With Prostate Cancer. Trials, record NCT02213107. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02213107

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Enzalutamide & Dutasteride/Finasteride as 1st Line Treatment for Patients =/> 65 Years Old With Prostate Cancer.
NCT number: NCT02213107
Status: Completed
Phases: Phase 2
Enrollment: 43 participants, actual
Lead sponsor: University of Rochester
Conditions: Prostate Cancer
Interventions: Enzalutamide and Dutasteride or finasteride
First posted: 2014-08-11
Last updated: 2024-11-13
Results first posted: 2024-11-13

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Prostate Specific Antigen (PSA) Progression Free Survival	3 years.	Percentage of participants with progression-free survival at 3 years. PSA disease progression is defined as an increase in the PSA that is \>=25% and \>=2 ng/ml above the nadir PSA value.
Secondary	Absolute PSA Response	up to approximately 8 years	Lowest PSA value achieved.
Secondary	Time to PSA Nadir	up to approximately 8 years	Time (months) to achieve the lowest PSA value compared to baseline PSA level
Secondary	Number of Participants Who Experience a Treatment-related Adverse Events.	up to approximately 8 years	Adverse events will be defined according to CTCAE version 4.0.
Other	Number of Participants With a Change in Bone Density	baseline to week 103	Change in bone density at week 103 compared to baseline bone density, measured using DEXA study.
Other	Mean Quality of Life	baseline to week 61	Change in quality of life score at follow up compared to baseline score, using FACT-P survey. The FACT-P survey is a 39 item questionnaire with a score that ranges from 0-156 with higher scores indicating better quality of life.
Other	Comprehensive Geriatric Assessment Domains	Week 1 to approximately 36 months	Change in comprehensive geriatric assessment domains at follow up compared to baseline evaluation.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Prostate Specific Antigen (PSA) Progression Free Survival	3 years.	This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on considering subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as a single treatment group. As a result, primary study outcome analyses were performed by including subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.	percentage of participants	NUMBER
SECONDARY	Absolute PSA Response	up to approximately 8 years	This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for this outcome included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group. One patient has missing data at 8 years	ng/dl	MEDIAN
SECONDARY	Time to PSA Nadir	up to approximately 8 years	This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for this outcome included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group. One subject has missing data at 8 years	months	MEDIAN
SECONDARY	Number of Participants Who Experience a Treatment-related Adverse Events.	up to approximately 8 years	This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for this outcome included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Number of Participants With a Change in Bone Density	baseline to week 103
OTHER_PRE_SPECIFIED	Mean Quality of Life	baseline to week 61
OTHER_PRE_SPECIFIED	Comprehensive Geriatric Assessment Domains	Week 1 to approximately 36 months

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Prostate Specific Antigen (PSA) Progression Free Survival	Enzalutamide and Dutasteride or Finasteride	85.3	95% Confidence Interval 70.0 to 93.1	percentage of participants
Absolute PSA Response	Enzalutamide and Dutasteride or Finasteride	0.02	Full Range 0 to 2.75	ng/dl
Time to PSA Nadir	Enzalutamide and Dutasteride or Finasteride	8.05	Full Range 1.38 to 78.30	months
Number of Participants Who Experience a Treatment-related Adverse Events.	Enzalutamide and Dutasteride or Finasteride	43		Participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Enzalutamide and Dutasteride or Finasteride	43
Overall Study	COMPLETED	Enzalutamide and Dutasteride or Finasteride	43
Overall Study	NOT COMPLETED	Enzalutamide and Dutasteride or Finasteride	0

Source ClinicalTrials.gov

Adverse events105

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Akathisia	Nervous system disorders	Use of Enzalutamide and Dutasteride or Finasteride	3	43
other	Alopecia	Skin and subcutaneous tissue disorders	Use of Enzalutamide and Dutasteride or Finasteride	6	43
other	Anemia	Blood and lymphatic system disorders	Use of Enzalutamide and Dutasteride or Finasteride	10	43
other	Anorexia	Metabolism and nutrition disorders	Use of Enzalutamide and Dutasteride or Finasteride	11	43
other	Athralgia	Immune system disorders	Use of Enzalutamide and Dutasteride or Finasteride	12	43
other	Breast pain	Reproductive system and breast disorders	Use of Enzalutamide and Dutasteride or Finasteride	5	43
other	Constipation	Gastrointestinal disorders	Use of Enzalutamide and Dutasteride or Finasteride	15	43
other	Diarrhea	Gastrointestinal disorders	Use of Enzalutamide and Dutasteride or Finasteride	14	43
other	Dizziness	Nervous system disorders	Use of Enzalutamide and Dutasteride or Finasteride	15	43
other	Dysgeusia	Nervous system disorders	Use of Enzalutamide and Dutasteride or Finasteride	9	43

1 to 10 of 105Source ClinicalTrials.gov

See all 105 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Use of Enzalutamide and Dutasteride or Finasteride	5	43
Total, other adverse events	Use of Enzalutamide and Dutasteride or Finasteride	43	43
Total, serious adverse events	Use of Enzalutamide and Dutasteride or Finasteride	26	43

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02213107

GET https://conductscience.org/api/trials/v1/NCT02213107/events?page=2

API reference For AI assistants