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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02057939
Recruitment Status : Completed
First Posted : February 7, 2014
Results First Posted : March 20, 2019
Last Update Posted : June 26, 2019
Sponsor:
Collaborators:
Medivation, Inc.
Astellas Pharma Inc
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE January 31, 2014
First Posted Date  ICMJE February 7, 2014
Results First Submitted Date  ICMJE February 27, 2019
Results First Posted Date  ICMJE March 20, 2019
Last Update Posted Date June 26, 2019
Actual Study Start Date  ICMJE April 2014
Actual Primary Completion Date March 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
Two Year Progression-free Survival [ Time Frame: 2 years ]
PFS defined as testosterone greater than 100 without one or more 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 OR death
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
  • PSA Less Than 0.1 [ Time Frame: every year, up to 3 years ]
    The percentage of men with PSA less than 0.1 ng/mL and testosterone greater than 100
  • 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
  • Biochemical Progression-free Survival [ Time Frame: 3 years ]
    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
  • PSA Nadir [ Time Frame: 8 weeks ]
    Median PSA nadir post-radiation therapy
  • Time to Testosterone Recovery [ Time Frame: 3 years ]
    Percentage of patients with recovering testosterone to > 100 at 1, 2, and 3 years.
  • Number of Patients With Adverse Events Related to Combination Enzalutamide, ADT, and XRT [ Time Frame: 3 years ]
    Safety and tolerability will be assessed using CTCAE v4.0
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
  • PSA Less Than 0.1 [ Time Frame: every year, up to 3 years ]
    The proportion of men with PSA less than 0.1 ng/mL and testosterone greater than 100.
  • Three Year Progression-free Survival [ Time Frame: 3 years ]
    PFS defined as testosterone greater than 100 without one or more 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 OR death
  • Biochemical Progression-free Survival [ Time Frame: every 3 months, up to 3 years ]
    PFS defined as testosterone greater than 100 without one or more 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 death
  • PSA Nadir [ Time Frame: every 3 months, up to 3 years ]
    Describe median PSA nadir
  • Length of time to testosterone recovery [ Time Frame: every 3 months, up to 3 years ]
    Length of time for testosterone levels to recover to > 100
  • Number of Patients With Adverse Events Related to Combination Enzalutamide, ADT, and XRT [ Time Frame: every 3 months, up to 3 years ]
    Safety and tolerability will be assessed using CTCAE v4.0
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Salvage Therapeutic Radiation With Enzalutamide and ADT in Men With Recurrent Prostate Cancer (STREAM)
Official Title  ICMJE Salvage Therapeutic Radiation With Enzalutamide and ADT in Men With Recurrent Prostate Cancer (STREAM)
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: enzalutamide
    160 mg orally once daily for six months
    Other Name: Xtandi
  • Drug: Androgen Deprivation
    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 Name: leuprolide acetate (Lupron Depot, 22.5 mg)
  • Radiation: Radiation Therapy
    Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy
Study Arms  ICMJE Experimental: Enzalutamide
Enzalutamide, Androgen Deprivation, and Radiation Therapy
Interventions:
  • Drug: enzalutamide
  • Drug: Androgen Deprivation
  • Radiation: Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2014)
38
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 5, 2019
Actual Primary Completion Date March 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02057939
Other Study ID Numbers  ICMJE Pro00049865
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • Medivation, Inc.
  • Astellas Pharma Inc
Investigators  ICMJE
Principal Investigator: Andrew Armstrong, MD ScM FACP Duke University
PRS Account Duke University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP