Actively Recruiting
Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-04-06
150
Participants Needed
6
Research Sites
358 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG Performance status 2 or less
- Age 18 years or older
- Histologically confirmed adenocarcinoma of the prostate
- Continuous androgen ablative therapy with surgical castration or LHRH agonist/antagonist
- Castrate serum testosterone level below 50 ng/dl
- Radiographically documented metastatic disease by CT or bone scan
- Disease progression while on abiraterone acetate plus ADT by PSA or radiographic criteria
- Screening PSA 1.0 ng/mL or higher
- Agreement to biopsy if soft tissue lesions are present
- No prior enzalutamide, apalutamide, darolutamide, or investigational AR targeted treatment
- Prior testosterone treatment allowed
- Prior chemotherapy with docetaxel (6 doses or less) for hormone-sensitive prostate cancer allowed
- Prior Provenge vaccine and 223Radium allowed if more than 4 weeks from last dose
- Abiraterone discontinued for at least 2 weeks
- Attempts to wean prednisone before starting therapy; lowest dose allowed if weaning not possible
- Acceptable liver function: Bilirubin less than 2.5 times ULN; AST and ALT less than 2.5 times ULN
- Acceptable renal function: serum creatinine less than 2.5 times ULN
- Acceptable blood counts: ANC 1500/mm3 or higher; platelets 100,000/mm3 or higher; hemoglobin 8 g/dL or higher
- At least 4 weeks since prior radiation or chemotherapy
- Ability to understand and sign informed consent
You will not qualify if you...
- Pain from metastatic prostate cancer requiring treatment with pain medication
- ECOG Performance status 3 or higher
- Prior treatment with enzalutamide
- Prior chemotherapy with docetaxel or cabazitaxel for castration-resistant prostate cancer
- Requires urinary self-catheterization due to prostate cancer or BPH obstruction
- Risk factors for testosterone therapy such as femoral metastases with fracture risk, severe spinal metastases, or extensive liver metastases
- Serious or unstable medical, psychiatric, or other conditions affecting safety or consent
- Active uncontrolled infections including HIV/AIDS or hepatitis B or C
- Conditions impairing ability to consent, safety, or compliance
- Use of warfarin, rivaroxaban, or apixaban anticoagulation therapy
- History of thromboembolic event in last 12 months without treatment
- Hematocrit above 51%, untreated severe sleep apnea, uncontrolled heart failure
- Allergy to sesame seed oil or cottonseed oil
- Major surgery within 3 weeks before screening or incomplete recovery from prior surgery
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Trial Site Locations
Total: 6 locations
1
University of California, San Diego (UCSD)
San Diego, California, United States, 92037
Actively Recruiting
2
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
3
Dana-Faber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
5
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
6
University of Washington/Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
G
GU oncology
CONTACT
H
Harry Cao, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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