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Intermediate Risk Prostate CancerPhase 2NCT02028988

Enzalutamide + External Beam Rt For Prostate

A Phase 2 study testing Enzalutamide and External Beam Radiation in people with Intermediate Risk Prostate Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.

Completed

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

Official record
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Trial summary

This research study is evaluating a drug called enzalutamide in combination with external beam radiation therapy as a possible treatment for prostate cancer. Presently, when participants receive hormonal therapy with radiation therapy for prostate cancer, medications are given to reduce testosterone levels in the… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Intermediate Risk Prostate Cancer
What is being tested?
Enzalutamide and External Beam Radiation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
3 sitesUnited States
Study dates
Feb 2014to Jan 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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Study population: Participants must have histologically confirmed malignancy and are candidates for external beam radiation therapy. Patients eligible for this study must have intermediate risk disease defined as PSA values between 10-20 ng/ml and/or T2b-c and/or Gleason grade 7. If all three are present, less than 50% of the core biopsies can be positive.
  • Patients previously diagnosed with low risk (Gleason score < 6, clinical stage < T2a, and PSA< 10) prostate cancer undergoing active surveillance who are re-biopsied and found to have intermediate risk disease according to the protocol criteria are eligible for enrollment within 180 days of the repeat biopsy procedure.
  • Age 18 years or more.
  • Life expectancy of greater than 1 year.
  • ECOG performance status ≤ 2 (see Appendix D).
  • Participants must have normal organ and marrow function as defined below:
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  • Leukocytes ≥3,000/mcL
  • Platelets ≥80,000/mcL
  • Total bilirubin < 2X institutional upper limit
  • AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
  • Creatinine < 2x institutional limits .
  • The effects of enzalutamide on the developing human fetus are unknown. For this reason and because enzalutamide may be teratogenic, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
  • Ability to understand and the willingness to sign a written informed consent

Who cannot join

  • Patients must NOT meet any of the following exclusion criteria
  • Received an investigational agent within 4 weeks prior to enrollment
  • Stage T4 prostate cancer by clinical examination or radiologic evaluation.
  • Hypogonadism or severe androgen deficiency as defined by screening serum testosterone less than 50 ng/dL below the normal range for the institution.
  • Prior androgen deprivation, chemotherapy, surgery, or radiation for prostate cancer.
  • Receiving concurrent androgens, anti-androgens, estrogens, or progestational agents, or received any of these agents within the 6 months prior to enrollment or having taken finasteride or dutasteride within 30 days of registration.
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  • History of another active malignancy within the previous 5 years other than curatively treated nonmelanomatous skin cancer and superficial bladder cancer. Participants treated for malignancy with no relapse within two years are eligible to participate in the study.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection.
  • Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment.
  • Unwilling to use contraceptives while on study if relevant to patient.
  • History of seizure or any condition or concurrent medication that may predispose to seizure.
  • History of loss of consciousness or transient ischemic attack within 12 months prior to enrollment.
  • Clinically significant cardiovascular disease, including:
  • Myocardial infarction within 3 months of enrollment;
  • Uncontrolled angina within 3 months of enrollment;
  • Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan performed within 3 months results in a left ventricular ejection fraction ≥ 45%;
  • History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes);
  • History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place;
  • Hypotension as indicated by systolic blood pressure < 86 mmHg on 2 consecutive measurements at the Screening visit;
  • Bradycardia as indicated by a heart rate < 50 beats per minute at the Screening visit;
  • Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg on 2 consecutive measurements at the screening visit;
  • EKG demonstrating equal to or greater than grade III toxicity according the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
  • History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of oral study drug(s) within 3 months of enrollment.
  • Major surgery within 4 weeks of registration.
  • Previous use, or participation in a clinical trial, of an investigational agent that blocks androgen synthesis (e.g., abiraterone acetate, TAK-700, TAK-683, TAK-448) or targets the androgen receptor (e.g., enzalutamide, BMS 641988); ketoconazole.
  • Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, places the patient at undue risk, or complicates the interpretation of safety data.
  • Need for any of the medications on the list of drugs to be used with caution or to be avoided (see APPENDIX F).
  • Use of herbal or alternative remedies that may affect hormonal status such as Prostasol or PC-SPES.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Enzalutamide With External Beam Radiation for Intermediate Risk Prostate Cancer: A Phase II Study

This research study is evaluating a drug called enzalutamide in combination with external beam radiation therapy as a possible treatment for prostate cancer. Presently, when participants receive hormonal therapy with radiation therapy for prostate cancer, medications are given to reduce testosterone levels in the blood stream. This leads to side effects such as loss of sex drive, erectile dysfunction (ED) and decrease in muscle strength. The purpose of this study is test another form of hormonal therapy with radiation therapy. The medication called enzalutamide will be used with radiation therapy. Instead of lowering testosterone, enzalutamide blocks testosterone in cells. This study will test if enzalutamide when used with radiation will lower the PSA without causing the side effects associated with medications that lower testosterone in the blood stream.

Read the detailed description
  • The participant will be given a study drug-dosing diary for each of 6 treatment cycles. Each treatment cycle lasts 28 days (4 weeks), during which time the participant will be taking the study drug enzalutamide by mouth (4 pills daily). The diary will also include special instructions for taking the enzalutamide.
  • The participant will also be undergoing external beam radiation therapy during the study, for a duration of 8 ½-10 weeks. Treatment will be administered on an outpatient basis. This part of the study is considered standard of care.
  • The participant will be required to have fiducial markers placed within the prostate as part of this study. These are very small gold markers that are placed in the prostate. This procedure is similar to the biopsy that the participant had to diagnose their cancer. This procedure is routinely performed to permit imaging and position corrections to improve the precision of the external beam (radiation) delivery (Image Guided Radiation Therapy). The placement of the three gold markers is performed by an Urologist. The fiducials are placed under ultrasound guidance. This is also considered standard of care and is not experimental.
  • Planned Follow-up: Participants will be followed on study at a 3 month follow-up after treatment (cessation of enzalutamide). Additional follow-up to assess the status of the participant's cancer will be conducted at the discretion of the treating physicians as part of the participant's routine medical care.
Being tested
Enzalutamide, External Beam Radiation
Keywords
Intermediate Risk Prostate Cancer

What participants receive

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

  • EnzalutamideDrug

    Also called Xtandi

  • External Beam RadiationRadiation

Study groups in NCT02028988
Study groupRoleWhat they receive
Enzalutamide with External Beam RadiationExperimentalEnzalutamide 40 mg orally 4x daily for 6 (28 day +/-3 days) cycles. External Beam Radiation Therapy (EBRT) - 7-10 weeks after beginning Enzalutamide 75.6 to 79.2 Gy in 1.8 Gy fractions for up to 11 weeks. *Patients that are unable to complete enzalutamide therapy will still be treated with EBRT
Receives: Drug: Enzalutamide; Radiation: External Beam Radiation

What is being measured

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

  1. Percentage of Participants With PSA at or Below 0.2 ng/ml

    Percentage of participants with PSA level of less than or equal to 0.2 ng/ml at the end of six cycles of enzalutamide and EBRT treatment. Post-treatment PSA nadir level has been shown to be a validated intermediate cancer endpoint in similar settings. The chosen cut-off of 0.2 ng/ml was informed by D'Amico et al Lancet Oncology 2012. PSA levels determined through established methods (blood draw and serum analysis).

    Measured: End of treatment, up to 27 weeks.

Secondary outcomes (22)

  1. Median DHEA-S

    Median DHEA-S, collected and assessed using established methods. Reference range is 28-640 ug/dL for adult males.

    Measured: Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks

  2. Median Androstenedione

    Median androstenedione, collected and assessed using established methods. Reference range is 40-150 ng/dL for adult males.

    Measured: Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks

  3. Median Testosterone

    Median testosterone, collected and assessed using established methods. Reference range is 300-1050 ng/dL for adult males.

    Measured: Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks

  4. Median Free Testosterone

    Median free testosterone, collected and assessed using established methods. Reference range is 350-1200 ng/dL for adult males.

    Measured: Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks

  5. Median Estrone

    Median estrone, collected and assessed using established methods. Reference range is 12-72 pg/mL for adult males.

    Measured: Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks

  6. Median Estradiol

    Median estradiol, collected and assessed using established methods. The reference range is 13-42 pg/mL for adult males.

    Measured: Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks

  7. Median Bicep Fat Fold Measurement

    Median bicep fat fold measurement taken at baseline and end of treatment.

    Measured: At baseline and end of treatment, up to 27 weeks

  8. Median Tricep Fat Fold Measurement

    Median tricep fat fold measurement taken at baseline and end of treatment.

    Measured: At baseline and end of treatment, up to 27 weeks

  9. Median Shoulder Blade Fat Fold Measurement

    Median shoulder blade fat fold measurement taken at baseline and end of treatment.

    Measured: At baseline and end of treatment, up to 27 weeks

  10. Median Waist Fat Fold Measurement

    Median waist fat fold measurement taken at baseline and end of treatment.

    Measured: At baseline and end of treatment, up to 27 weeks

  11. Median Waist Circumference

    Median waist circumference taken at baseline and end of treatment.

    Measured: At baseline and end of treatment, up to 27 weeks

  12. Median Weight

    Median weight taken at baseline and end of treatment.

    Measured: At baseline and end of treatment, up to 27 weeks

  13. Number of Participants With a Sleep Quality Score of 0 or 1

    Sleep quality measure of the Pittsburgh Sleep Quality Index (PSQI) is scored from 0-3 [0=Very bad, 1=Fairly bad, 2=Fairly good, 3=Very good]. The higher the score, the better the sleep quality.

    Measured: Measured at cycles 1, 3, and 5.

  14. Urinary Incontinence Median Score

    Urinary incontinence evaluated using the Expanded-Prostate Index Composite - 26 (EPIC 26) EPIC-26 evaluates patient's urinary incontinence (4 items). The 4 items are reported on a scale of 0 - 100. A higher score indicates better urinary function.

    Measured: Measured at cycles 1, 3, and 5.

  15. Urinary Irritation Median Score

    Urinary irritation evaluated using the Expanded-Prostate Index Composite - 26 (EPIC 26). EPIC-26 evaluates urinary irritation/obstruction (4 items). The final score from the 4 items is reported on a scale of 0 - 100. A higher score indicates better urinary function.

    Measured: Measured at cycles 1, 3, and 5.

  16. Bowel Function Median Score

    Bowel function measure through the Expanded-Prostate Index Composite - 26 (EPIC 26). EPIC-26 evaluates patient's bowel (6 items). The 6 items are reported on a scale of 0 - 100. A higher score indicates better urinary function.

    Measured: Measured at cycles 1, 3, and 5.

  17. Sexual Function Median Score

    Sexual function measure through The Expanded-Prostate Index Composite - 26 (EPIC 26). EPIC-26 evaluates patient's sexual function (5 items). The 5 items are reported on a scale of 0 - 100.A higher score indicates better urinary function.

    Measured: Measured at cycles 1, 3, and 5.

  18. Hormone Function Median Score

    Hormone function evaluated by the Expanded-Prostate Index Composite - 26 (EPIC 26). EPIC-26 evaluates patient's hormonal function (5 items). The 5 items are reported on a scale of 0 - 100. A higher score indicates better urinary function.

    Measured: Measured at cycles 1, 3, and 5.

  19. Number of Participants With a Fatigue Score of 3 or 4

    Feeling fatigue measure of the Patient-Reported Outcome Measurement Information System (PROMIS)-Fatigue Short Form is scored from 0-4 [0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much]. The higher the score, the more fatigued the patient is.

    Measured: Cycles 1, 3, and 5

  20. Median Collagen Type 1 C-Telopeptide

    Median Collagen Type 1 C-Telopeptide is a biomarker for bone metabolism measured and analyzed using established methods. Reference range for adult males is 60-1200 pg/mL

    Measured: Measured at baseline, end of treatment, and at 3 month follow-up, up to 40 weeks

  21. Median Bone-Specific Alkaline Phosphatase

    Median Bone-Specific Alkaline Phosphatase is a biomarker for bone metabolism measured and analyzed using established methods. Reference range for adult males is 7.5-69.8 ug/L

    Measured: Measured at baseline, end of treatment, and at 3 month follow-up, up to 40 weeks

  22. Median Procollagen Type II Intact N Terminal Propeptide

    Median Procollagen Type II Intact N Terminal Propeptide is a biomarker for bone metabolism measured and analyzed using established methods. Reference range for adult males is 22-87 ug/L

    Measured: Measured at baseline, end of treatment, and at 3 month follow-up, up to 40 weeks

Timeline

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

  1. First posted7 Jan 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionOct 2017
  4. Study completionJan 2018

Resources

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
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02028988
Sponsor's protocol ID
13-444
Status last verified
Apr 2023
First submitted
16 Dec 2013
Last updated
6 May 2023
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Kaplan I, Bubley GJ, Bhatt RS, Taplin ME, Dowling S, Mahoney K, Werner E, Nguyen P. Enzalutamide With Radiation Therapy for Intermediate-Risk Prostate Cancer: A Phase 2 Study. Int J Radiat Oncol Biol Phys. 2021 Aug 1;110(5):1416-1422. doi: 10.1016/j.ijrobp.2021.02.027. Epub 2021 Feb 23.

    PubMed 33636278

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enzalutamide and External Beam Radiation in people with Intermediate Risk Prostate Cancer, run by Dana-Farber Cancer Institute at 3 sites 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 13 inclusion and 28 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 6 May 2023). 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?

Percentage of Participants With PSA at or Below 0.2 ng/ml (time frame: End of treatment, up to 27 weeks.). 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 NCT02028988, 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 6 May 2023; AzTrials last refreshed its copy on 28 Oct 2026.

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