Actively Recruiting
Bipolar Androgen Therapy (BAT) and Radium-223 (RAD) in Metastatic Castration-resistant Prostate Cancer (mCRPC)
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-02-06
47
Participants Needed
2
Research Sites
353 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
This is a single-arm, multicenter open label, international, phase II study of Bipolar Androgen Therapy (BAT) plus Radium-223 (RAD) in men with metastatic castration-resistant prostate cancer (mCRPC). Men with mCRPC with progressive disease (radiographically and/or biochemically) who have been treated with gonadotropin-releasing hormone (GnRH)-analogue (LHRH agonists/antagonists) continuously or bilateral orchidectomy will be enrolled in this study. Previous antiandrogen therapies are permitted, but no more than one (such as abiraterone, enzalutamide, apalutamide, darolutamide). All patients will receive treatment with Radium-223 at a dose of 55 Kilobecquerel (kBq) per kilogram of body weight IV every 28 days, for 6 cycles, plus Testosterone Cypionate 400mg Intramuscular (IM) every 28 days, until progression or unacceptable toxicity.
CONDITIONS
Official Title
Bipolar Androgen Therapy (BAT) and Radium-223 (RAD) in Metastatic Castration-resistant Prostate Cancer (mCRPC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the prostate with more than 50% adenocarcinoma if mixed tumor
- Bone metastases shown by bone scan within 2 months before screening
- Castration-resistant prostate cancer with castrate testosterone levels (≤ 50 ng/dL) and evidence of progression
- PSA level of at least 2.0 ng/mL
- On bone health agents (zoledronic acid or denosumab) for at least 4 weeks before enrollment and continuing during study
- ECOG performance status 0 or 1
- Asymptomatic or minimally symptomatic without opioid use
- Prior treatment with no more than one novel androgen receptor targeted drug
- Prior chemotherapy for hormone-sensitive prostate cancer allowed if completed ≥ 12 months before study
- Adequate bone marrow, kidney, and liver function
- No other malignancies within 5 years except treated skin cancer
- Availability of tissue for genomic analysis
You will not qualify if you...
- Presence of known visceral metastases (lung, liver, brain)
- Spinal cord compression, imminent long bone fracture, or conditions needing radiation or steroids for pain
- Previous chemotherapy for mCRPC or any chemotherapy within 12 months
- Radiation therapy within 28 days before registration
- Systemic bone-targeted radionuclide therapy within 24 weeks
- Use of strong opioid analgesics for cancer pain
- Use of experimental drugs within 4 weeks
- Patients with intact prostate and urinary obstructive symptoms
- Use of warfarin anticoagulation therapy
- Symptomatic nodal disease causing edema
- Serious uncontrolled medical disorders or infections
- Disease extent increasing risk from testosterone therapy
- Patients with low volume visceral metastasis allowed only if bone disease predominates
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Amber Michalik
Baltimore, Maryland, United States, 20707
Actively Recruiting
2
Moinhos de Vento Hospital
Porto Alegre, Brazil, 90560-010
Not Yet Recruiting
Research Team
R
Rana Sullivan, RN
CONTACT
A
Amber Michalik, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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