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Hormone Therapy
BAT + Radium-223 for Prostate Cancer (BAT-RAD Trial)
Phase 2
Recruiting
Led By Samuel Denmeade, M,D
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Screening Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Asymptomatic or minimally symptomatic disease (no opioids)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
BAT-RAD Trial Summary
This trial is testing a new treatment for men with metastatic prostate cancer that hasn't responded to other treatments. The new treatment is a combination of two drugs, one of which is testosterone.
Who is the study for?
Men with advanced prostate cancer that has spread to the bones and is resistant to hormone therapy can join. They should have tried hormone-blocking treatments, but only one newer drug like abiraterone or enzalutamide. No recent chemo for mCRPC, no major health issues unrelated to cancer, and they must not be using strong painkillers like morphine.Check my eligibility
What is being tested?
The trial tests a combination of high-dose testosterone injections (BAT) and Radium-223 (RAD), a radioactive drug targeting bone metastases. Participants will receive these treatments every 28 days for up to six cycles, monitoring for disease progression or unacceptable side effects.See study design
What are the potential side effects?
Possible side effects include flu-like symptoms, diarrhea, nausea, swelling in limbs due to fluid buildup; low blood counts leading to increased infection risk or bleeding; fatigue; bone pain flare-up after RAD injection; and potential risks from high testosterone levels.
BAT-RAD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My disease causes little to no pain, and I don't take opioids.
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My blood, kidney, and liver tests are within normal ranges.
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I haven't had any cancer except skin cancer in the last 5 years.
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My prostate cancer is mainly adenocarcinoma, confirmed by a biopsy or surgery report.
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I have been on zoledronic acid or denosumab for bone health for over 4 weeks.
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My prostate cancer is resistant to hormone therapy and my testosterone is low.
BAT-RAD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radiographic progression-free survival (rPFS) of BAT-RAD
Secondary outcome measures
Change in Quality of life as assessed by anxiety/depression EuroQol 5 dimensions 3 levels (EQ-5D-3L)
Change in Quality of life as assessed by the Brief Pain Inventory-Short Form (BPI-SF)
Change in Quality of life as assessed by the Functional Assessment of Cancer Therapy- Prostate (FACT-P)
+7 moreOther outcome measures
Percentage of patients with somatic (tumor) or germline (inherited) mutations
BAT-RAD Trial Design
1Treatment groups
Experimental Treatment
Group I: Bipolar Androgen Therapy in addition to RADium-223 (RAD)Experimental Treatment2 Interventions
Participants will receive Bipolar Androgen Therapy (BAT) plus Radium-223 (RAD).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
radium-223
2016
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,873 Total Patients Enrolled
Samuel Denmeade, M,DPrincipal InvestigatorSidney Kimmel Comprehensive Cancer Center at the Johns Hopkins Hospital
Pedro Isaacsson Velho, M,DPrincipal InvestigatorMoinhos de Vento Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had chemotherapy for advanced prostate cancer or any reason in the last year, but not within the last 6 months if it was for early-stage or hormone-sensitive prostate cancer.I use strong painkillers like oxycodone for my cancer pain. Weak painkillers like tramadol are okay.I am fully active or can carry out light work.I can provide tissue samples for genetic testing.I have a serious health condition that is not well-controlled.My cancer has spread to areas where testosterone therapy could be risky.My PSA levels have increased and I have new bone or soft tissue cancer lesions.I am not on warfarin but may be taking other blood thinners.I don't need radiation or steroids for pain from spinal issues or possible bone fractures.You have taken a new, experimental drug within the past 4 weeks.My disease causes little to no pain, and I don't take opioids.My blood, kidney, and liver tests are within normal ranges.I may have had chemotherapy for prostate cancer over a year ago.I haven't had any cancer except skin cancer in the last 5 years.I have bone metastases confirmed by a recent scan.I have had only one new type of hormone therapy for cancer, but older hormone treatments are okay.I do not have urinary problems due to an enlarged prostate.My prostate cancer is mainly adenocarcinoma, confirmed by a biopsy or surgery report.I have swelling in my groin, penis, or legs due to cancer.I have been on zoledronic acid or denosumab for bone health for over 4 weeks.My prostate cancer is resistant to hormone therapy and my testosterone is low.My cancer has spread to organs like the lung, liver, or brain.I have undergone radiation therapy within the last 28 days.I haven't had specific bone metastasis treatments in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Bipolar Androgen Therapy in addition to RADium-223 (RAD)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been recruited for this experiment?
"Affirmative. According to the data on clinicaltrials.gov, this clinical trial is still open and actively seeking patients since it was initially posted on April 28th 2022. The study requires 47 participants from 2 distinct sites for recruitment."
Answered by AI
Is this a pioneering clinical investigation?
"Presently, there are 7 active Bipolar Androgen Therapy (BAT) trials operating in 40 cities and 4 nations. This medical research dates back to Merck Sharp & Dohme LLC's 2017 Phase 2 trial involving 45 participants; since then 8 further studies have reached completion."
Answered by AI
Has the FDA officially sanctioned Bipolar Androgen Therapy (BAT) for medical use?
"Since the data for Bipolar Androgen Therapy (BAT) is only up to Phase 2, there are no efficacy studies conducted yet. Thus, this treatment has been assigned a safety rating of 2 out of 3 by our team at Power."
Answered by AI
Is this experiment currently accepting participants?
"Per the details posted on clinicaltrials.gov, this medical research is currently recruiting participants and was initially uploaded April 28th 2022 with a subsequent update the following day."
Answered by AI
Has Bipolar Androgen Therapy been evaluated in past clinical research?
"Currently, there are seven ongoing studies assessing the efficacy of Bipolar Androgen Therapy (BAT), with one in its most advanced phase. While many trials for BAT originate from Bethesda, Maryland, 62 medical sites across the globe have opened their doors to those studying this therapy."
Answered by AI
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