Prostate CancerPhase 2NCT02064582
Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer
A Phase 2 study testing Enzalutamide, Leuprolide acetate and radiation in people with Prostate Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Enzalutamide, Leuprolide acetate and radiation
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 9 Jun 2018
- 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 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- uncontrolled intercurrent illness
- cardiovascular event within 6 months of enrollment
- seizure or seizure disorder history
- contraindications to MRI- pacemakers, clips, etc
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Enzalutamide and GnRH Agonist Before, During and After Radiation Therapy in Treatment of Patients With High-risk Localized Prostate Cancer
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.
Read the detailed description
- this pilot study will assess the safety and tolerability of combining enzalutamide with an gonadotropin-releasing hormone agonist (GnRH) and external beam radiation
- Correlative imaging and tissue biopsy analysis will be performed to assess the radiographic response to enzalutamide plus gonadotropin-releasing hormone agonist (GnRH) therapy as well as intratumoral androgen signaling
- Conditions
- Prostate Cancer
- Being tested
- Enzalutamide, Leuprolide acetate, radiation
- Keywords
- prostate cancer, enzalutamide, radiation, hormone therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnzalutamideDrug
Also called Xtandi
160mg by mouth each day
Leuprolide acetateDrug
Also called Lupron
22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months
radiationRadiation
External beam radiation will be delivered as per standard radiation therapy protocol
| Study group | Role | What they receive |
|---|---|---|
| Enzalutamide, Leuprolide, radiation | Other | 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 Receives: Drug: Enzalutamide; Drug: Leuprolide acetate; Radiation: radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Measured: 12 months following initiation of treatment with enzalutamide plus GnRH agonist
Secondary outcomes (1)
Fold Change in Intra-tumoral Androgen Regulated Gene Expression Pre and Post Combination Therapy
Fold change of Intra-tumoral Androgen Regulated Gene Expression (PSA, FKBP5, TMPRSS2, and NDRG1) will be measure at 12 months post therapy.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startMay 2014
- Primary completion9 Jun 2018
- Study completion9 Jun 2018
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 Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Responsible party
- Principal investigator, Kevin Dale Courtney, University of Texas Southwestern Medical Center
- Investigators
- Kevin D Courtney, MD, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064582
- Sponsor's protocol ID
- STU 082013-032
- Status last verified
- Sep 2020
- First submitted
- 10 Feb 2014
- Last updated
- 12 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Li J, Alyamani M, Zhang A, Chang KH, Berk M, Li Z, Zhu Z, Petro M, Magi-Galluzzi C, Taplin ME, Garcia JA, Courtney K, Klein EA, Sharifi N. Aberrant corticosteroid metabolism in tumor cells enables GR takeover in enzalutamide resistant prostate cancer. Elife. 2017 Feb 13;6:e20183. doi: 10.7554/eLife.20183.
PubMed 28191869
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Enzalutamide and GnRH Agonist Before, During and After Radiation Therapy in Treatment of Patients With High-risk Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT02064582
- Acronym / sponsor ID
- STU 082013-032
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, enzalutamide, radiation, hormone therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- May 2014 (actual)
- Primary completion
- 9 Jun 2018 (actual)
- Study completion
- 9 Jun 2018 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Posted 12 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- this pilot study will assess the safety and tolerability of combining enzalutamide with an gonadotropin-releasing hormone agonist (GnRH) and external beam radiation
- Correlative imaging and tissue biopsy analysis will be performed to assess the radiographic response to enzalutamide plus gonadotropin-releasing hormone agonist (GnRH) therapy as well as intratumoral androgen signaling
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enzalutamide, Leuprolide, radiation | Other | Drug: Enzalutamide, Drug: Leuprolide acetate, Radiation: 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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: Xtandi160mg by mouth each day | Drug | Enzalutamide, Leuprolide, radiation |
| Leuprolide acetateAlso: Lupron22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months | Drug | Enzalutamide, Leuprolide, radiation |
| radiationExternal beam radiation will be delivered as per standard radiation therapy protocol | Radiation | Enzalutamide, Leuprolide, radiation |
Primary outcome
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
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
1 secondary outcome
Fold Change in Intra-tumoral Androgen Regulated Gene Expression Pre and Post Combination Therapy
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28191869Li J, Alyamani M, Zhang A, Chang KH, Berk M, Li Z, Zhu Z, Petro M, Magi-Galluzzi C, Taplin ME, Garcia JA, Courtney K, Klein EA, Sharifi N. Aberrant corticosteroid metabolism in tumor cells enables GR takeover in enzalutamide resistant prostate cancer. Elife. 2017 Feb 13;6:e20183. doi: 10.7554/eLife.20183.
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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.
Kevin D Courtney, MD, PhD principal investigator
University of Texas Southwestern Medical Center
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, Leuprolide acetate and radiation in people with Prostate Cancer, run by University of Texas Southwestern Medical Center 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 6 inclusion and 10 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 12 Oct 2020. 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 12 Oct 2020). 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?
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). 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 NCT02064582, 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 12 Oct 2020.