Actively Recruiting
Bipolar Androgen Therapy (BAT) and Radium-223 (RAD) in Metastatic Castration-resistant Prostate Cancer (mCRPC) (BAT-RAD Study)
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-02-06
47
Participants Needed
2
Research Sites
52 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 research evaluates Bipolar Androgen Therapy (BAT) combined with Radium-223 (RAD) in men who have metastatic castration-resistant prostate cancer (mCRPC) with progressive disease despite previous hormone therapy. Men eligible have been treated continuously with gonadotropin-releasing hormone analogues or had surgical removal of testes and may have had up to one previous antiandrogen therapy. This international, open-label, phase II study aims to explore this combined treatment approach in this patient population. Participants will receive Radium-223 intravenously at a dose of 55 kBq per kilogram of body weight every 28 days for six cycles. Alongside this, they will be given Testosterone Cypionate 400 mg by intramuscular injection every 28 days until disease progression or unacceptable side effects occur. This single-arm study does not involve comparison groups, focusing on the combined treatment's effect. During the study, participants will undergo regular assessments including bone scans, PSA blood tests, and quality of life questionnaires such as the EQ-5D-3L, FACT-P, and BPI-SF at baseline and various treatment cycles. Researchers will monitor disease progression, survival, skeletal events, and safety over a 24-month period, with careful tracking of adverse events and treatment impact. Participants will be followed until progression or for up to 10 months for safety evaluations.
CONDITIONS
Brief 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 at least 50% adenocarcinoma tissue
- Bone metastases confirmed by a bone scan within 2 months before screening
- Castrate-resistant prostate cancer with castrate testosterone levels (≤ 50 ng/dL) and evidence of disease progression
- Serum PSA level ≥ 2.0 ng/mL
- Currently receiving bone health agents (zoledronic acid or denosumab) for at least 4 weeks prior to enrollment
- ECOG performance status of 0 or 1
- Asymptomatic or minimally symptomatic disease without opioid use
- Prior treatment with no more than one novel androgen receptor targeted drug permitted
- Adequate bone marrow, kidney, and liver function
- No prior malignancies within 5 years except certain skin cancers
- Availability of tissue for genomic analysis from biopsy or archived samples
You will not qualify if you...
- Presence of known visceral metastases such as lung, liver, or brain
- Conditions requiring radiation or steroids for pain control such as spinal cord compression or imminent bone fracture
- Prior chemotherapy for metastatic castration-resistant prostate cancer or chemotherapy within 12 months
- Radiation therapy within 28 days before registration
- Use of certain bone-targeted radionuclide therapies within 24 weeks
- Use of opioid analgesics for cancer pain (except weak opioids like codeine or tramadol)
- Use of experimental drugs within 4 weeks before treatment
- Intact prostate with urinary obstructive symptoms
- Use of warfarin anticoagulation therapy
- Symptomatic nodal disease causing swelling
- Serious uncontrolled medical disorders or infections that may affect safety
- Disease extent posing high risk from testosterone therapy such as femoral or severe spinal metastases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months (6 cycles of 28 days each)
Participants receive Bipolar Androgen Therapy (BAT) with Testosterone Cypionate 400mg IM every 28 days and Radium-223 IV every 28 days for 6 cycles.
Monthly visits for 6 cycles
Duration - Up to 24 months
Participants are monitored for treatment outcomes and safety for up to 24 months after starting treatment.
Periodic visits during follow-up up to 24 months
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
A
Amber Michalik, BA
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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