Trial of Radiotherapy With Leuprolide and Enzalutamide in High Risk Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT02508636|
Recruitment Status : Completed
First Posted : July 27, 2015
Last Update Posted : September 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms Pelvic Nodal||Drug: Enzalutamide Drug: Leuprolide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Definitive Radiotherapy With Leuprolide and Enzalutamide in High Risk Prostate Cancer|
|Actual Study Start Date :||December 22, 2015|
|Actual Primary Completion Date :||August 31, 2020|
|Actual Study Completion Date :||August 31, 2020|
Experimental: Single Arm
Enzalutamide: 160 mg (for 40 mg capsules) per day; Oral - swallow capsules hole, with or without food; Enzalutamide therapy to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months.
Leuprolide: any duration formulation: single 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months; Intramuscular injection
Other Name: Xtandi
Other Name: Lupron Depot
- Rate of acute treatment-related toxicity [ Time Frame: ≤ 90 days within the completion of radiotherapy ]Percentage of participants with acute, treatment-related toxicity (≤90 days within the completion of radiotherapy) for any treatment-related adverse events as classified by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- Rate of late treatment-related toxicity [ Time Frame: Up to 3 years ]Percentage of participants with late, treatment-related, toxicity is defined as any toxicity occurring >= 90 days from completion of radiotherapy for any treatment-related adverse events as classified by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Patients will be monitored at least weekly during treatment and every 3-6 months up to 24 months and at 36 months after radiation therapy.
- Prostate Specific Antigen-Complete Response (PSA-CR) Rate [ Time Frame: Up to 127 days ]A PSA measurement will be obtained at 120-127 days after initiation of androgen deprivation therapy. The proportion of patients achieving a PSA-CR (PSA nadir ≤0.3) at 120-127 days will be determined. The historical proportion of patients (0.7) attaining a PSA-CR from Radiation Therapy Oncology Group (RTOG) 9413 will be utilized for comparison.
- Time to biochemical failure [ Time Frame: Up to 3 years ]≥2 ng/mL from the nadir PSA per the Phoenix Definition
- Local progression [ Time Frame: Up to 3 years ]Biopsy proven recurrence
- Regional progression [ Time Frame: Up to 3 years ]Imaging or biopsy
- Distant progression [ Time Frame: Up to 3 years ]Imaging or biopsy
- Time to clinical progression [ Time Frame: Up to 3 years ]Date of PSA failure, local failure, regional or distant metastases
- Changes in hemoglobin A1c (HbA1c) levels during treatment [ Time Frame: Up to 2 years ]Changes in HbA1c will be assessed at baseline, 12, and 24 months during treatment
- Changes in fasting insulin levels during treatment [ Time Frame: Up to 2 years ]Changes in fasting insulin will be assessed at will be assessed at baseline, 12, and 24 months during treatment
- Changes in fasting glucose levels during treatment [ Time Frame: Up to 2 years ]Changes in fasting glucose will be assessed at baseline, 12, and 24 months during treatment
- Changes in lipid and cholesterol levels during treatment [ Time Frame: Up to 2 years ]Changes in fasting lipid and cholesterol levels will be assessed at baseline, 12, and 24 months during treatment
- Expanded Prostate Cancer Index Composite (EPIC) [ Time Frame: up to 3 years ]The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment and assesses the disease-specific aspects of prostate cancer and its therapies and comprises four summary domains (Urinary, Bowel, Sexual and Hormonal). Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life
- Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: up to 3 years ]PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. A PROMIS score of 50 is the average (or mean) score for a specific, relevant group of people under investigation. That group is the reference population. The PROMIS measures the responses use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. A score of 40 is one SD lower than the mean of the reference population and a score of 60 is one SD higher than the mean of the reference population. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.
- EuroQol Group five dimensional questionnaire (EQ-5D) [ Time Frame: up to 3 years ]EQ-5D is a standardized instrument for measuring generic health status. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The respondents self-rate their level of severity for each dimension using three-level (EQ-5D-3L) or five-level (EQ-5D-5L) scale, with lower levels indicating less issues/problems with that particular health dimension.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02508636
|United States, California|
|University of California San Francisco|
|San Francisco, California, United States, 94158|
|Principal Investigator:||Hao Nguyen, MD||University of California, San Francisco|