Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression
United States150 participantsStarted 2020-08-19
Plain-language summary
Asymptomatic men without pain due to prostate cancer progressing with metastatic CRPC after treatment with combination or sequential ADT + Abi will be treated on a randomized, open label study to determine if sequential treatment with high dose T and Enza will improve primary and secondary objectives vs. continuous Enza as standard therapy.
Who can participate
Age range
18 Years – 90 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
. ECOG Performance status ≤2.
. Age ≥18 years.
. Histologically-confirmed adenocarcinoma of the prostate.
. Treated with continuous androgen ablative therapy (either surgical castration or LHRH agonist/antagonist).
. Documented castrate level of serum testosterone (\<50 ng/dl).
. Metastatic disease radiographically documented by CT or bone scan.
. Must have had disease progression while on combination of abiraterone acetate plus ADT either given concurrently or sequentially based on:
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.
What they're measuring
1
Clinical or Radiographic Progression free survival
Timeframe: Up to 2 years
Trial details
NCT IDNCT04363164
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
. Pain due to metastatic prostate cancer requiring treatment intervention with pain medication.
. ECOG Performance status ≥3
. Prior treatment with enzalutamide is prohibited.
. Prior chemotherapy with docetaxel or cabazitaxel for castration resistant prostate cancer is prohibited.
. Requires urinary self-catheterization for voiding due to obstruction secondary to prostatic enlargement well documented to be due to prostate cancer or benign prostatic hyperplasia (BPH). Patients with indwelling Foley or suprapubic catheter for obstructive symptoms are eligible.
. Evidence of disease in sites or extent that, in the opinion of the investigator, would put the patient at risk from therapy with testosterone (e.g. femoral metastases with concern over fracture risk, severe and extensive spinal metastases with concern over spinal cord compression, extensive liver metastases).
. Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.
. Active uncontrolled infection, including known history of HIV/AIDS or hepatitis B or C.