Bipolar Androgen Therapy (BAT) and Radium-223 (RAD) in Metastatic Castration-resistant Prostate Cancer (mCRPC)
Bipolar Androgen Therapy (BAT) and Radium-223 (RAD) in Metastatic Castration-resistant Prostate Cancer (mCRPC) (BAT-RAD Study)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests testosterone shots, called bipolar androgen therapy (BAT), plus radium-223, a radiation drug. It is for men whose prostate cancer has spread to the bones and is getting worse despite treatment to lower testosterone.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- A tissue test must confirm prostate adenocarcinoma, a type of prostate cancer. If the cancer has mixed types, more than half must be adenocarcinoma.
- A recent bone scan must show cancer in at least one bone.
- Cancer must be getting worse despite very low testosterone from ongoing hormone treatment or surgery to remove both testicles. PSA, a blood marker for prostate cancer, must be at least 2 ng/mL.
- You must take zoledronic acid or denosumab to protect your bones for at least 4 weeks before joining and throughout the study.
- You must be able to do most daily activities and have no symptoms or only mild symptoms.
- You may have used no more than one newer drug that blocks male hormones. Some earlier chemotherapy is allowed; the study team must check the timing.
- Blood tests must show that your bone marrow, kidneys, and liver work well enough. You must have had no other cancer in the past 5 years, except certain successfully treated skin cancers.
- Tumor tissue must be available for gene testing. Stored tissue can be used, or a new biopsy may be done.
Who can't join
- Cancer in organs such as the lungs, liver, or brain is generally excluded. The rules also allow some small amounts of organ spread if most cancer is in the bones; the study doctor must decide.
- Pressure on the spinal cord, a bone likely to break, or disease that may need radiation or steroids for pain. Cancer that makes testosterone treatment unsafe also excludes you.
- Prior chemotherapy for cancer that resisted hormone treatment, or recent chemotherapy. The listing gives different timing rules for other chemotherapy, so the study team must check.
- Radiation treatment within 28 days, certain radioactive drugs for bone cancer within 24 weeks, or an experimental drug within 4 weeks.
- Strong opioid pain drugs, such as morphine, for cancer pain. The rules differ on weaker opioids such as codeine or tramadol; ask the study team.
- Trouble passing urine while you still have your prostate, or cancer in lymph nodes causing swelling in the scrotum, penis, or legs.
- Taking warfarin, a blood thinner. Other blood thinners are allowed.
- A serious uncontrolled illness, infection, or other condition that could make treatment unsafe or prevent you from giving informed consent or following study rules.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Histologically documented adenocarcinoma of the prostate confirmed by pathology report from prostate biopsy or a radical prostatectomy specimen. If prostatic tumor is of mixed histology, \> 50% of the tumor must be adenocarcinoma. * Bone metastases as manifested by one or more lesions on a Technetium 99m bone scan performed within 2 months of screening * Castrate-resistant prostate cancer, in the setting of castrate levels of testosterone (≤ 50 ng/dL), defined as current or historical evidence of disease progression concomitant with surgical castration or androgen deprivation therapy (ADT), as demonstrated by two consecutive rises in PSA OR new lesions on bone scan: * PSA progression will be defined as 2 rising PSA values compared to a reference value, measured at least 7 days apart and the second value is ≥ 2 ng/mL. Appearance of one or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the precastration studies if there was no response. Increased uptake of pre-existing lesions on bone scan does not constitute progression. It must be documented within 8 weeks of screening Documented bone lesions by the appearance of ≥ 2 new lesions by bone scintigraphy or dimensionally measurable soft tissue metastatic lesion assessed by CT or MRI. * Serum PSA ≥ 2.0 ng/mL * Patients must be on bone health agents, either zoledronic acid or denosumab, for at least 4 weeks before enrollment. These treatments must then be continued during the study. * Screening Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 * Asymptomatic or minimally symptomatic disease (no opioids) * Prior treatment with no more than one novel AR targeted drug (abiraterone, enzalutamide, darolutamide or apalutamide) is permitted, but not required. Prior first-generation AR targeted therapies such as bicalutamide or nilutamide are permitted as previous therapy and does not count as novel AR targeted therapy. * Prior chemotherapy for hormone-sensitive prostate cancer (given ≥ 12 months prior to study entry) is allowed, but not necessary. * Adequate bone marrow, renal and liver function (Absolute Neutrophil count \> 1,000, Platelets \>100,000, Hemoglobin ≥ 9g/dL aspartate aminotransferase/ alanine amino transferase (AST)/(ALT) within normal limits (WNL); Total Bilirubin WNL. * No evidence (within 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin). * All patients must have tissue for genomic analysis. A biopsy of a metastatic site may be done during the screening; however, archive tissue will be allowed. Prostate tissue from prostate biopsy will be allowed. Exclusion Criteria: * The presence of known visceral metastasis, including lung, liver and brain metastases. * Spinal cord compression, imminent long bone fracture, or any other condition that, in the opinion of the investigator, is likely to require radiation therapy and/or steroids for pain control during the active phase. * Previous treatment with chemotherapy for mCRPC, or chemotherapy for any reason within 12 months prior to registration. (Chemotherapy in the adjuvant setting or for hormone-sensitive prostate cancer is permitted, as long as it was completed more than 6 months before registration). * History of radiation therapy, either via external beam or brachytherapy within 28 days prior to registration. * Systemic therapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks * Use of opioid analgesics for cancer-related pain such as oxycodone, morphine or methadone. Weak opioid analgesics such as codeine or tramadol are permitted. * Use of experimental drug within 4 weeks of treatment. * Patients with an intact prostate AND urinary obstructive symptoms are excluded (which includes patients with urinary symptoms from benign prostatic hyperplasia (BPH). * Patients receiving anticoagulation therapy with warfarin are not eligible for study. Patients on other anticoagulants such as rivaroxaban, dabigatran, apixaban are permitted. * Symptomatic nodal disease, i.e. scrotal, penile or leg edema. * Poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection or a disease that may compromise safety. Examples include, but are not limited to, diabetes, heart failure, chronic obstructive pulmonary disease (COPD), ulcerative colitis, or Crohn's disease, Paget's disease, ventricular arrhythmia, recent (within 12 months) myocardial infarction, thromboembolic events or any psychiatric disorder that prohibits obtaining informed consent. Any medical intervention, any other condition, or any other circumstance which, in the opinion of the investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives. * 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, etc). Patients with low volume visceral metastasis are permitted at the discretion of the investigator, however bone disease must be predominant.
Study sites (1)
MD
- Amber Michalik · Baltimore, MD 20707Amber Michalik, BA · Study contact · 667-306-8336 · amichal2@jhmi.eduMore trials in Baltimore