Study of Abiraterone Acetate or Enzalutamide, Atezolizumab, GnRH Analog and Radiation Therapy in … (NCT04262154) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of Abiraterone Acetate or Enzalutamide, Atezolizumab, GnRH Analog and Radiation Therapy in Men With Newly Diagnosed Hormone-sensitive Prostate Cancer
United States28 participantsStarted 2020-03-03
Plain-language summary
This study is to find out whether adding the study drug atezolizumab and stereotactic body radiotherapy (SBRT) to standard treatment with abiraterone acetate, prednisone, and Lupron® (leuprolide) is a safe and effective way to treat previously untreated metastatic prostate cancer, and to see whether the study treatment works better than the standard treatment.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Willing and able to provide or have a legally authorized representative to provide written informed consent and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.
NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
* Males 18 years of age and above
* Untreated metastatic (M1a/b/c) hormone-sensitive prostate cancer documented by positive bone scan or metastatic lesion on CT or MRI; untreated is defined as having never received surgical, radiotherapeutic, or systemic therapy to the prostate for cancer for their prostate cancer.
Note, 10 subjects who have had prior hormonal therapy (GnRH analog +/- first-generation anti-androgen such a bicalutamide) started up to 3 months prior to signing consent to the trial will be permitted to enroll onto the study if they have demonstrated a decline in PSA. Anti-androgens must be stopped prior to Cycle 1.
Note: patients who have started bicalutamide (Casodex) with or without a GnRH analog must stop prior to being registered on trial
* Biopsy-proven adenocarcinoma of the prostate
* Eligible for SBRT per institutional guidelines
* ECOG status of 0 or 1
* Normal organ function with acceptable initial laboratory values within 14 days of treatment start:
ANC ≥ 1,500 /µl Lymphocyte count ≥ 0.5 x 109/L (500/µL) Albumin ≥ 3.5 g/dL Hemoglobin ≥ 9 g/dL Platelet count ≥ 100,000 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.