Trial · Interventional

CompletedPhase 2Results postedRegistry data

Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer

NCTNCT02064582Other idSTU 082013-032

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 7 participants (actual)
Sponsor: University of Texas Southwestern Medical Center · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: May 2014
Primary completion: 9 Jun 2018
Completion: 9 Jun 2018
First posted: 17 Feb 2014 (estimated)
Last update posted: 12 Oct 2020
Conditions: Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201420152016201720182019

Ph 2
Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer
NCT02064582
May 2014 to 9 Jun 2018

Registry summary

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

The study is being done to find out whether combining two FDA approved drugs along with radiation therapy for the treatment of high risk localized prostate cancer is safe and well tolerated.

Interventions

EnzalutamideDrug
Leuprolide acetateDrug
radiationRadiation

Arms1

Other
Enzalutamide, Leuprolide, radiation
Single arm Enzalutamide 160 mg daily for 6 months Leuprolide acetate 22.5mg every 3 months or 45mg every 6 months Radiation therapy as standard of care

Primary outcomes1

Outcomes the sponsor listed as primary.

Safety, as Measured by the Number of Patients With at Least One Adverse Event as Assess by NCI Common Terminology Criteria for Adverse Events (CTCAE) vs. 40 When Combining Enzalutamide With a GnRH and External Beam Radiation
Time frame · 12 months following initiation of treatment with enzalutamide plus GnRH agonist
Registry description
Assessment will number of participants who experience adverse events greater than or equal to Grade 3, as defined by NCI Common terminology criteria for adverse events(CTCAE) v4.0

Secondary outcomes(1)

Fold Change in Intra-tumoral Androgen Regulated Gene Expression Pre and Post Combination Therapy
Time frame · 12 months
Registry description
Fold change of Intra-tumoral Androgen Regulated Gene Expression (PSA, FKBP5, TMPRSS2, and NDRG1) will be measure at 12 months post 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 outcomeCount of participants· 12 months following initiation of treatment with enzalutamide plus GnRH agonist

Safety, as Measured by the Number of Patients With at Least One Adverse Event as Assess by NCI Common Terminology Criteria for Adverse Events (CTCAE) vs. 40 When Combining Enzalutamide With a GnRH and External Beam Radiation

Group	Value (Participants)
Enzalutamide, Leuprolide, Radiation	0

Secondary and other outcome results(1)

Secondary outcomeMedian· 12 months

Fold Change in Intra-tumoral Androgen Regulated Gene Expression Pre and Post Combination Therapy

Group	Value (Fold change)
Enzalutamide, Leuprolide, Radiation	0.54

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Enzalutamide, Leuprolide, RadiationSingle arm Enzalutamide 160 mg daily for 6 months Leuprolide acetate 22.5mg every 3 months or 45mg every 6 months Radiation therapy as standard of care Enzalutamide: 160mg by mouth each day Leuprolide acetate: 22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months radiation: External beam radiation will be delivered as per standard radiation therapy protocol	0 / 7	0 / 7	7 / 7

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years up to 90 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * histologically proven adenocarcinoma of the prostate within 6 months of screening * Eastern Cooperative Oncology Group(ECOG) score 0-2 * adequate organ and and blood marrow function * must be a candidate for long-term androgen deprivation in combination with external beam radiation for the treatment of high risk prostate cancer * patient must permit a targeted prostate biopsy at the time of study initiation or at the beginning of radiation treatment * men who are sexually active with female partners of child-bearing potential mush agree to use adequate contraception Exclusion Criteria: * prior treatment with agents known to have endocrine effects on prostate cancer * treatment with corticosteroids within 4 weeks of enrollment * treatment with androgens within 6 months of enrollment * may not be receiving any other investigational agents * Prostate specific antigen greater than 160ng/dL * history of malignancy( other than non-melanoma skin cancer) within 5 years * uncontrolled intercurrent illness * cardiovascular event within 6 months of enrollment * seizure or seizure disorder history * contraindications to MRI- pacemakers, clips, etc

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