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New treatment option for Prostate Adenocarcinoma
Official title Bipolar Androgen Therapy (BAT) and Radium-223 (RAD) in Metastatic Castration-resistant Prostate Cancer (mCRPC)
ClinicalTrials.gov ID: NCT04704505
What this study is testing
What is Bipolar Androgen Therapy (BAT)?
Bipolar Androgen Therapy (BAT) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for prostate adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only. Healthy volunteers may be eligible.
You may be able to join if
- Histologically documented adenocarcinoma of the prostate confirmed by pathology report from prostate biopsy or a radical prostatectomy specimen. If...
- 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...
- 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...
- Serum PSA ≥ 2.0 ng/mL
You likely can't join if
- 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...
- Previous treatment with chemotherapy for mCRPC, or chemotherapy for any reason within 12 months prior to registration. (Chemotherapy in the adjuvant...
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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)...
- 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.
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Porto Alegre, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Porto Alegre, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.