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Hormone Therapy

Radium-223 + Hormone Therapy + SBRT for Metastatic Prostate Cancer

Q: How many subjects are enrolled in this research project?

Affirmative. According to information posted on clinicaltrials.gov, this trial was initially listed on August 29th 2018 and modified as recently as September 14th 2022. It is currently recruiting 24 patients at a single site.

Q: Has Degarelix attained regulatory endorsement from the FDA?

Given the limited data in Phase 2 clinical trials, our team at Power has assigned Degarelix a safety score of two. Thus far, there is evidence that the drug may be safe but none to support its efficacy.

Q: Is the recruitment process for this research still open?

Evidenced on clinicaltrials.gov, this trial is actively recruiting patients - the initial post was made August 29th 2018 and most recently updated September 14th 2022.

Q: What ailments can Degarelix be employed to address?

Degarelix is used for the management of cervical syndrome, but it also serves as an efficacious treatment for minor burns, stage T2B carcinoma of the <a href="https://www.withpower.com/clinical-trials/prostate">prostate</a> and transplantation.

Q: Is this research the inaugural endeavor of its type?

Presently, 221 Degarelix trials are ongoing in 1424 cities and across 56 nations. The first research on this drug was conducted by AstraZeneca in the year 2000 with a Phase 3 approval process involving 600 participants. Since then, 1571 further studies have been completed.

Q: Can you brief me on the investigations done regarding Degarelix?

At present, 221 live clinical trials are in progress for Degarelix with 62 of them being Phase 3. Most of the studies occur at a single site located in Duarte, <a href="https://www.withpower.com/clinical-trials/california">California</a>; however, there is also research being conducted across 7801 different locations worldwide.

Phase 2

Waitlist Available

Led By Savita Dandapani, MD

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Castration resistance defined as progression of disease despite serum testosterone level of < 50 ng/dL

* Only luteinizing hormone-releasing hormone (LHRH) agonist/antagonist treatment is considered ADT, bicalutamide or other antiandrogens used alone do not count

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying radium Ra 223 dichloride, hormone therapy, and stereotactic body radiation to treat prostate cancer that has spread to other parts of the body.

Who is the study for?

This trial is for men with prostate cancer that has spread, who have started hormone therapy recently and have a life expectancy over 12 months. They should not have had chemotherapy for metastatic disease but may have tried one non-chemotherapy treatment. Men must be able to undergo radiation if they haven't already treated the primary tumor site, and their blood counts and liver function need to meet specific levels.Check my eligibility

What is being tested?

The study tests combining radium Ra 223 (a radioactive substance targeting bone metastases), hormone therapy (lowering testosterone), and stereotactic body radiation (precise high-dose radiation) in treating advanced prostate cancer. The goal is to see if this combination works better than current treatments.See study design

What are the potential side effects?

Possible side effects include fatigue, nausea, bone marrow suppression leading to low blood cell counts, potential harm to normal tissues from radiation, hormonal changes due to therapy like hot flashes or sexual dysfunction, and typical risks associated with receiving radioactivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My prostate cancer has progressed despite low testosterone levels.

Select...

I am only on LHRH treatment for my cancer, not just antiandrogens like bicalutamide.

Select...

I am able to get out of my bed or chair and move around.

Select...

I have been diagnosed with prostate cancer.

Select...

My cancer has spread to other parts of my body.

Select...

I will have surgery to reduce my prostate cancer before other treatments.

Select...

My condition is not resistant to hormone therapy.

Select...

I have up to 4 areas where my cancer has spread.

Select...

I have at least one bone lesion and all my non-organ tumors are smaller than 5 cm.

Select...

I have chosen not to receive the standard chemotherapy for my metastatic disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate

Time to treatment failure

Secondary outcome measures

Bone specific progression-free survival

Complete response (CR) rate defined as the proportion of patients achieving CR

Duration of overall complete response

+5 more

Other outcome measures

Genome

Immune biomarker analysis

Rate of normalization of the total alkaline phosphatase level

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (hormone therapy, SBRT, radium Ra 223 dichloride)Experimental Treatment6 Interventions

Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Leuprolide

FDA approved

Goserelin

FDA approved

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

Radium Ra 223 Dichloride

2017

Completed Phase 2

~90

Degarelix

FDA approved

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,435 Total Patients Enrolled

Savita Dandapani, MDPrincipal InvestigatorCity of Hope Medical Center

Media Library

Goserelin Acetate (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03361735 — Phase 2

Prostate Adenocarcinoma Research Study Groups: Treatment (hormone therapy, SBRT, radium Ra 223 dichloride)

Prostate Adenocarcinoma Clinical Trial 2023: Goserelin Acetate Highlights & Side Effects. Trial Name: NCT03361735 — Phase 2

Goserelin Acetate (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03361735 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are enrolled in this research project?

"Affirmative. According to information posted on clinicaltrials.gov, this trial was initially listed on August 29th 2018 and modified as recently as September 14th 2022. It is currently recruiting 24 patients at a single site."

Answered by AI

Has Degarelix attained regulatory endorsement from the FDA?

"Given the limited data in Phase 2 clinical trials, our team at Power has assigned Degarelix a safety score of two. Thus far, there is evidence that the drug may be safe but none to support its efficacy."

Answered by AI

Is the recruitment process for this research still open?

"Evidenced on clinicaltrials.gov, this trial is actively recruiting patients - the initial post was made August 29th 2018 and most recently updated September 14th 2022."

Answered by AI

What ailments can Degarelix be employed to address?

"Degarelix is used for the management of cervical syndrome, but it also serves as an efficacious treatment for minor burns, stage T2B carcinoma of the prostate and transplantation."

Answered by AI

Is this research the inaugural endeavor of its type?

"Presently, 221 Degarelix trials are ongoing in 1424 cities and across 56 nations. The first research on this drug was conducted by AstraZeneca in the year 2000 with a Phase 3 approval process involving 600 participants. Since then, 1571 further studies have been completed."

Answered by AI

Can you brief me on the investigations done regarding Degarelix?

"At present, 221 live clinical trials are in progress for Degarelix with 62 of them being Phase 3. Most of the studies occur at a single site located in Duarte, California; however, there is also research being conducted across 7801 different locations worldwide."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radium Ra 223 Dichloride, Hormone Therapy and Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Prostate Cancer

2018. "Radium Ra 223 Dichloride, Hormone Therapy and Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03361735.

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