- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02057939
Salvage Therapeutic Radiation With Enzalutamide and ADT in Men With Recurrent Prostate Cancer (STREAM) (STREAM)
June 12, 2019 updated by: Duke University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New Jersey
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New Brunswick, New Jersey, United States, 08903
- Rutgers Cancer Institute of New Jersey
-
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Health
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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)
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Enzalutamide
Enzalutamide, Androgen Deprivation, and Radiation Therapy
|
160 mg orally once daily for six months
Other Names:
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.
Other Names:
Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Two Year Progression-free Survival
Time Frame: 2 years
|
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
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PSA Less Than 0.1
Time Frame: every year, up to 3 years
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The percentage of men with PSA less than 0.1 ng/mL and testosterone greater than 100
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every year, up to 3 years
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Three Year Progression-free Survival
Time Frame: 3 years
|
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
|
3 years
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Biochemical Progression-free Survival
Time Frame: 3 years
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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
|
3 years
|
PSA Nadir
Time Frame: 8 weeks
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Median PSA nadir post-radiation therapy
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8 weeks
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Time to Testosterone Recovery
Time Frame: 3 years
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Percentage of patients with recovering testosterone to > 100 at 1, 2, and 3 years.
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3 years
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Number of Patients With Adverse Events Related to Combination Enzalutamide, ADT, and XRT
Time Frame: 3 years
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Safety and tolerability will be assessed using CTCAE v4.0
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3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrew Armstrong, MD ScM FACP, Duke University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2014
Primary Completion (Actual)
March 2, 2018
Study Completion (Actual)
June 5, 2019
Study Registration Dates
First Submitted
January 31, 2014
First Submitted That Met QC Criteria
February 6, 2014
First Posted (Estimate)
February 7, 2014
Study Record Updates
Last Update Posted (Actual)
June 26, 2019
Last Update Submitted That Met QC Criteria
June 12, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Reproductive Control Agents
- Fertility Agents, Female
- Fertility Agents
- Leuprolide
- Androgens
Other Study ID Numbers
- Pro00049865
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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