Actively Recruiting
Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-03-11
60
Participants Needed
1
Research Sites
429 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
B
Bayer
Collaborating Sponsor
AI-Summary
What this Trial Is About
The objective of this study is to determine the safety and clinical effects of alternating pharmacologic (i.e. supraphysiologic) testosterone therapy with darolutamide in men with metastatic prostate cancer as first line hormonal therapy. Correlative studies will be conducted to assess the effect of alternating therapy on quality of life, gene expression and metabolic changes associated with alternating therapy.
CONDITIONS
Official Title
Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Performance status 2 or less
- Histologically confirmed adenocarcinoma of the prostate
- Baseline PSA level of 1.0 ng/ml or higher
- No prior androgen deprivation therapy for biochemically recurrent or metastatic disease (prior AD therapy allowed if given at least 1 year before recurrence in radiation therapy context)
- No prior treatment with androgen receptor pathway inhibitors for recurrent or metastatic prostate cancer (allowed if given at least 1 year before metastatic disease in radiation therapy context)
- Prior focal radiation for oligometastatic disease allowed if more than 6 months ago, with evidence of metastases in non-irradiated sites
- Evidence of rising PSA on two dates at least 2 weeks apart
- Evidence of metastatic disease on recent CT or bone scan within 6 weeks of screening
- Bone pain allowed only if pain-free after 6-month lead-in phase to receive subsequent therapy
- Agreement to baseline and 6-month tumor biopsies if soft tissue lesions are present
- Acceptable liver, renal, and blood function based on specified laboratory values
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior chemotherapy treatment
- Prior treatment with Pluvicto or other PSMA-targeted agents
- Prior investigational androgen receptor targeted agents
- Serious or unstable medical or psychiatric conditions interfering with safety or consent
- Disease conditions increasing risk from testosterone therapy (e.g., certain bone or lymph node metastases)
- Requirement for urinary self-catheterization due to prostate enlargement
- Active uncontrolled infection
- Conditions impairing ability to consent or comply
- Use of Warfarin or Coumadin anticoagulation therapy (non-coumadin anticoagulants allowed)
- Hematocrit over 51%, untreated severe obstructive sleep apnea, or poorly controlled heart failure
- Allergy to sesame seed oil or cottonseed oil
- Major surgery within 3 weeks before screening or unhealed surgical wounds
- Abnormal cardiac function including NYHA class III/IV heart failure or recent myocardial infarction
- Inability to provide informed consent
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Trial Site Locations
Total: 1 location
1
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21205
Actively Recruiting
Research Team
R
Rana Sullivan, RN
CONTACT
D
Donna Bieg, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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