radium-223 for Prostate Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Johns Hopkins School of Medicine - Sidney Kimmel Comprehensive Cancer Center, Baltimore, MDProstate Adenocarcinoma+2 Moreradium-223 - Radiation
Eligibility
18+
Male
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Prostate Adenocarcinoma
  • Prostate Cancer
  • Castration-resistant Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Pilot Trial: Osanetant 28 Days
1
Docetaxel
1
Treatment (discontinue hormonal medication, follow up)

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: 24 months

24 months
Overall survival of BAT-RAD
PSA decline ≥ 50 percent rate (PSA50) of BAT-RAD
PSA progression-free survival (PSA-PFS) of BAT-RAD
Percentage of patients with somatic (tumor) or germline (inherited) mutations
Radiographic progression-free survival (rPFS) of BAT-RAD
Symptomatic skeletal event-free survival
Time to disease progression of BAT-RAD
Day 28
Change in alkaline phosphatase of BAT-RAD
Day 28
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)
Up to 10 months
Safety of BAT-RAD in patients with mCRPC as assessed by number of participants removed for adverse events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Pilot Trial: Osanetant 28 Days
1
Docetaxel
2
Treatment (discontinue hormonal medication, follow up)

Trial Design

1 Treatment Group

Bipolar Androgen Therapy in addition to RADium-223 (RAD)
1 of 1

Experimental Treatment

47 Total Participants · 1 Treatment Group

Primary Treatment: radium-223 · No Placebo Group · Phase 2

Bipolar Androgen Therapy in addition to RADium-223 (RAD)Experimental Group · 2 Interventions: radium-223, Bipolar Androgen Therapy (BAT) · Intervention Types: Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
radium-223
2016
Completed Phase 2
~60

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
538 Previous Clinical Trials
31,037 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

Eligibility Criteria

Age 18+ · Male Participants · 12 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have mild or no symptoms related to your illness and don't require strong pain medications.
You have been treated with only one of the following drugs: abiraterone, enzalutamide, darolutamide, or apalutamide. You can also have been treated with older AR targeted therapies such as bicalutamide or nilutamide.
You may have received chemotherapy for hormone-sensitive prostate cancer at least a year before joining the study, but it is not required.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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