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New treatment option for Prostate Cancer
Official title A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
ClinicalTrials.gov ID: NCT02960022
What this study is testing
What is enzalutamide?
enzalutamide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for prostate cancer.
Also referred to as MDV3100, Xtandi.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide from the subjects participation in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study) which has completed, at a minimum, the primary analysis or the study specified evaluation period.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Subject must currently be receiving enzalutamide or assigned to receive enzalutamide (if on treatment suspension) for prostate cancer in a study...
- Subject is able to continue on the treatment regimen that they were receiving or were assigned to receive in the prior study. If in the...
- Subject is able to swallow enzalutamide capsules and comply with study requirements.
- Subject and female partner who is of childbearing potential must continue to use 2 forms of birth control, of which 1 must be highly effective and 1...
- Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration.
You likely can't join if
- Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which subject is enrolling...
- Subject requires treatment with or plans to use either of the following:
- New systemic therapy for people cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies...
- Investigational therapy other than enzalutamide.
- Subject is currently participating in an investigator-initiated treatment trial and receiving enzalutamide.
- Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study...
See the full eligibility criteria
Who can join
- Subject must currently be receiving enzalutamide or assigned to receive enzalutamide (if on treatment suspension) for prostate cancer in a study sponsored by Astellas or Medivation and, based on the investigator's...
- Subject is able to continue on the treatment regimen that they were receiving or were assigned to receive in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (e.g., dose...
- Subject is able to swallow enzalutamide capsules and comply with study requirements.
- Subject and female partner who is of childbearing potential must continue to use 2 forms of birth control, of which 1 must be highly effective and 1 must be a barrier method throughout the study and for 3 months after...
- Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration.
- Subject agrees not to participate in another treatment study while on treatment. Canada Specific:
- Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act...
- Subject must currently be receiving enzalutamide for breast cancer in a study sponsored by Astellas or Medivation/Pfizer and based on the investigator's assessment, benefit from continued treatment. people participating...
- Subject is able to continue on the treatment regimen that they were receiving in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (e.g., dropping of a combination...
- Subject is able to swallow enzalutamide capsules and comply with study requirements.
- Subject is either:
- Of nonchildbearing potential:
- postmenopausal (defined as no spontaneous menses for at least 12 months prior to Day 1 with follicle stimulating hormone (FSH) \> 40 IU/L at Day 1 for women \< 55 years of age),
- documented surgically sterile or status post hysterectomy (at least 1 month prior to Day 1),
- Or, if of childbearing potential,
- must have a negative urine pregnancy test at Day 1 before the first dose of study drug is administered,
- must use 2 acceptable methods of birth control starting at Day 1 and through 6 months after the final study drug administration,
- must not donate ova starting at first administration of study intervention and throughout 6 months after final study intervention administration. The 2 acceptable methods of birth control are as follows or per local...
- A barrier method (e.g., condom by a male partner) is required; AND
- One of the following is required:
- Placement of an intrauterine device (IUD) or intrauterine system (IUS);
- Additional barrier method including occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository;
- Vasectomy or other surgical castration at least 6 months before Day 1.
- The subject must not be breastfeeding at Day 1 or during the study period, and for 6 months after the final study drug administration.
- Subject agrees not to participate in another treatment study while on treatment.
What rules you out
- Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which subject is enrolling from.
- Subject requires treatment with or plans to use either of the following:
- New systemic therapy for people cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent...
- Investigational therapy other than enzalutamide.
- Subject is currently participating in an investigator-initiated treatment trial and receiving enzalutamide.
- Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation...
- Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which they are enrolling from.
- Subject requires treatment with or plans to use any of the following:
- New systemic therapy for their cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent...
- Investigational therapy other than enzalutamide.
- Subject is currently participating in an investigator-initiated treatment trial and receiving enzalutamide.
- Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation...
The study team makes the final eligibility decision.
Where it's taking place
- Anchorage, Alaska, United States
- Tucson, Arizona, United States
- Los Angeles, California, United States
- Orange, California, United States
- San Bernardino, California, United States
- San Diego, California, United States
- Stanford, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- Washington D.C., District of Columbia, United States
- Daytona Beach, Florida, United States
- Jacksonville, Florida, United States
- Chicago, Illinois, United States
- Springfield, Illinois, United States
- Jeffersonville, Indiana, United States
- Kansas City, Kansas, United States
- Lenexa, Kansas, United States
- Towson, Maryland, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
+ 189 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anchorage, Alaska, United States; Tucson, Arizona, United States; Los Angeles, California, United States; Orange, California, United States; San Bernardino, California, United States; San Diego, California, United States and 203 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.