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Prostate CancerPhase 2STREAMNCT02057939

Salvage Therapeutic Radiation With Enzalutamide and ADT in Men With Recurrent Prostate Cancer (STREAM)

A Phase 2 study testing enzalutamide, Androgen Deprivation and Radiation Therapy in people with Prostate Cancer, run by Duke University 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

The purpose of this study is to describe the 2 year progression-free survival in men with recurrent PSA-only disease after prostatectomy receiving combined enzalutamide and standard androgen-deprivation therapy (ADT) with salvage radiation therapy. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
enzalutamide, Androgen Deprivation and Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
3 sitesUnited States
Study dates
Apr 2014to 5 Jun 2019
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

  • Histologically confirmed diagnosis of prostate adenocarcinoma. Variants of prostate cancer, including neuroendocrine features and small cell carcinoma of the prostate, are not permitted.
  • Gleason sum of 7, 8, 9, or 10 at the time of prostatectomy.
  • PSA relapse within 4 years of prostatectomy defined by persistently detectable or rising PSA after surgery.
  • Evidence of disease recurrence or progression as evidenced by a PSA > 0.20. This requires 2 consecutive rises in PSA, at least 1 week apart, over the post-prostatectomy nadir or one PSA value above 0.20 ng/mL if the patient failed to achieve a post-prostatectomy nadir of < 0.2 ng/mL.
  • Age ≥ 18 years
  • Karnofsky performance status ≥ 70
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  • Adequate laboratory parameters
  • Adequate bone marrow function: ANC ≥1.5 x 109/L, Platelets ≥100 x 109/L, Hb >9g/dL
  • AST/SGOT and ALT/SGPT ≤ 2.5 x Institutional Upper Limit of Normal (ULN)
  • Serum bilirubin ≤ 1.5 x Institutional ULN
  • Serum creatinine ≤ 1.5 x Institutional ULN or 24-hour clearance ≥ 50 mL/min
  • A minimum of 4 weeks from any major surgery prior to registration.
  • Ability to swallow, retain, and absorb oral medication.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Must use a condom if having sex with a pregnant woman.
  • Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration.

Who cannot join

  • Radiographic evidence of metastatic disease. Patients with node-positive disease (<2 positive nodes) at the time of radical prostatectomy are eligible. Patients with pelvic nodes up to 2 cm by short axis at the time of screening are eligible. Patients with any enlarged lymph nodes in the retroperitoneum or above the aortic bifurcation or with pelvic nodes ≥ 2 cm must be excluded.
  • PSA > 4.0 ng/mL.
  • Testosterone level ≤ 100 ng/dL.
  • More than 1 month of prior hormone exposure or hormone exposure within 30 days of registration. Prior enzalutamide, ketoconazole, abiraterone, or TAK700 prohibited. Prior 5α reductase inhibitors are allowed.
  • Prior immunotherapy including sipuleucel-T.
  • Prior systemic chemotherapy (docetaxel, cabazitaxel, estramustine, other cytotoxic agents)
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  • History of solid organ or stem cell transplantation.
  • History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, prior head or traumatic brain injury with loss of consciousness, prior or current space-occupying lesion in the brain). Also, history of loss of consciousness or transient ischemic attack within 12 months of Day 1 visit.
  • Known or suspected brain metastasis or active leptomeningeal disease.
  • Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of enzalutamide or increase the risk of radiation (e.g., uncontrolled nausea, vomiting, diarrhea, malabsorption syndromes, prior small bowel resection, or inflammatory bowel disease).
  • Patients who have received prior prostate or pelvic radiotherapy, including external beam or brachytherapy.
  • Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy prior to registration.
  • Patients unable or unwilling to abide by the study protocol or cooperate fully with the investigator.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

The purpose of this study is to describe the 2 year progression-free survival in men with recurrent PSA-only disease after prostatectomy receiving combined enzalutamide and standard androgen-deprivation therapy (ADT) with salvage radiation therapy. Eligible men will have recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of 0.2 - 4 in the absence of metastatic disease on CT and bone scans. In addition to standard ADT and radiation therapy, research participants will take enzalutamide once daily for six months. It is primarily hypothesized the 2 year PFS rate will be improved with the combined therapy compared to the historical control data in a similar patients setting.

Conditions
Prostate Cancer
Being tested
enzalutamide, Androgen Deprivation, Radiation Therapy
Keywords
Prostate cancer, enzalutamide, ADT, radiation
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

    160 mg orally once daily for six months

  • Androgen DeprivationDrug

    Also called leuprolide acetate (Lupron Depot, 22.5 mg)

    Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.

  • Radiation TherapyRadiation

    Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy

Study groups in NCT02057939
Study groupRoleWhat they receive
EnzalutamideExperimentalEnzalutamide, Androgen Deprivation, and Radiation Therapy
Receives: Drug: enzalutamide; Drug: Androgen Deprivation; Radiation: Radiation Therapy

What is being measured

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

  1. Two Year Progression-free Survival

    Percentage of patients surviving 2 years from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of first documented progression or death due to any cause. Progression-free was defined as being without one of the following: serum PSA value of 0.2 ng/mL or more above post-radiotherapy PSA nadir that continues to increase 4 weeks later OR if no nadir is experienced, two rising PSA values over 4 or more weeks OR evidence of clinical progression or initiation of systemic therapy for progressive disease

    Measured: 2 years

Secondary outcomes (6)

  1. PSA Less Than 0.1

    The percentage of men with PSA less than 0.1 ng/mL and testosterone greater than 100

    Measured: every year, up to 3 years

  2. Three Year Progression-free Survival

    Percentage of patients surviving 3 years from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of first documented progression or death due to any cause. Progression-free was defined as being without one of the following: serum PSA value of 0.2 ng/mL or more above post-radiotherapy PSA nadir that continues to increase 4 weeks later OR if no nadir is experienced, two rising PSA values over 4 or more weeks OR evidence of clinical progression or initiation of systemic therapy for progressive disease

    Measured: 3 years

  3. Biochemical Progression-free Survival

    Percentage of patients surviving 2 and 3 years from the start of study treatment without progression of disease. Biochemical PFS was defined as the time from the date of study treatment initiation to the date of first documented progression or death due to any cause. Progression-free was defined as being without one of the following: serum PSA value of 0.2 ng/mL or more above post-radiotherapy PSA nadir that continues to increase 4 weeks later OR if no nadir is experienced, two rising PSA values over 4 or more weeks

    Measured: 3 years

  4. PSA Nadir

    Median PSA nadir post-radiation therapy

    Measured: 8 weeks

  5. Time to Testosterone Recovery

    Percentage of patients with recovering testosterone to > 100 at 1, 2, and 3 years.

    Measured: 3 years

  6. Number of Patients With Adverse Events Related to Combination Enzalutamide, ADT, and XRT

    Safety and tolerability will be assessed using CTCAE v4.0

    Measured: 3 years

Timeline

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

  1. First posted7 Feb 2014 (estimated)
  2. Study startApr 2014
  3. Primary completion2 Mar 2018
  4. Study completion5 Jun 2019

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
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02057939
Sponsor's protocol ID
Pro00049865
Acronym
STREAM
Status last verified
Jun 2019
First submitted
31 Jan 2014
Last updated
26 Jun 2019
Data monitoring committee
Yes

Publications

  • Bitting RL, Healy P, George DJ, Anand M, Kim S, Mayer T, Winters C, Riggan C, Rasmussen J, Wilder R, Stein M, Frizzell B, Harrison MR, Zhang T, Lee WR, Wu Y, Koontz BF, Armstrong AJ. Phase II Trial of Enzalutamide and Androgen Deprivation Therapy with Salvage Radiation in Men with High-risk Prostate-specific Antigen Recurrent Prostate Cancer: The STREAM Trial. Eur Urol Oncol. 2021 Dec;4(6):948-954. doi: 10.1016/j.euo.2020.01.005. Epub 2020 Feb 13.

    PubMed 32063492

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing enzalutamide, Androgen Deprivation and Radiation Therapy in people with Prostate Cancer, run by Duke University 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 16 inclusion and 14 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 26 Jun 2019. 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 20 Mar 2019). 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?

Two Year Progression-free Survival (time frame: 2 years). 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 NCT02057939, 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 26 Jun 2019.

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