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

Overseen By Savita Dandapani, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Must be taking: LHRH agonist/antagonist

Must not be taking: Chemotherapy

Disqualifiers: Brain metastases, Uncontrolled HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments for prostate cancer that has spread to other parts of the body. The researchers are examining the effectiveness of radium Ra 223, a radioactive substance targeting bones, in conjunction with hormone therapy (including drugs like Goserelin Acetate and Leuprolide Acetate) and a specialized form of radiation therapy called Stereotactic Body Radiation Therapy (SBRT). The goal is to determine if this combination can better control prostate cancer compared to other treatments. Men with prostate cancer that has spread to the bones and possibly other areas, but is not resistant to hormone therapy, might be suitable candidates. As a Phase 2 trial, this study focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, certain treatments like prior radium Ra 223 dichloride and chemotherapy for metastatic disease are not allowed. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the treatments in this clinical trial are generally safe based on previous studies. Goserelin acetate and leuprolide acetate, types of hormone therapy, have well-established safety records. In one study, 90% of doctors rated the safety of leuprolide acetate as good or excellent. Goserelin acetate has been safely used in many patients with prostate cancer.

Radium Ra 223 dichloride targets cancer in bones and also has a good safety record. Studies indicate that it is well-tolerated, with many patients completing several treatment cycles without serious side effects.

Stereotactic body radiation therapy (SBRT) is a precise form of radiation treatment. Research has shown it to be safe for treating prostate cancer, with positive results in many patients.

These findings suggest that the treatments in this trial are generally well-tolerated. However, discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this treatment for metastatic prostate cancer because it combines hormone therapy, SBRT (stereotactic body radiation therapy), and Radium-223, which work together in a unique way. Unlike standard treatments that often focus solely on hormone therapy to slow cancer growth, Radium-223 specifically targets and attacks cancer in the bones, which is a common site for prostate cancer metastasis. Additionally, SBRT delivers high doses of radiation precisely to cancer sites over a short period, potentially increasing effectiveness and reducing side effects compared to traditional radiation therapy. This combination approach aims to halt cancer progression more effectively by attacking it from multiple angles.

What evidence suggests that this trial's treatments could be effective for metastatic prostate cancer?

Research has shown that each treatment in this trial has potential for treating prostate cancer. Participants will receive a combination of treatments. Goserelin acetate has extended the lives of patients with advanced prostate cancer by lowering testosterone levels. Leuprolide acetate, another hormone therapy in this trial, also reduces testosterone, helping to control prostate cancer growth. Radium Ra 223 dichloride targets cancer cells in the bones and has been linked to longer survival when patients complete several treatment cycles. Stereotactic body radiation therapy (SBRT) precisely targets and reduces the spread of prostate cancer while minimizing damage to nearby tissues. Overall, these treatments have effectively managed and improved outcomes for prostate cancer. ^{1 3 5 6 7}

Who Is on the Research Team?

Savita Dandapani, MD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Platelets >= 100,000/mm^3 (to be performed within 14 days prior to day 1 of protocol therapy)

Total serum bilirubin =< 2 x upper limit of normal (ULN) (to be performed within 14 days prior to day 1 of protocol therapy)

Aspartate aminotransferase (AST) =< 2.5 x ULN (to be performed within 14 days prior to day 1 of protocol therapy)

Exclusion Criteria

I have previously received radium Ra 223 treatment.

I have or am receiving chemotherapy for cancer that has returned or spread, with some exceptions.

I am receiving radiation therapy targeted at my prostate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Hormone Therapy

Participants receive leuprolide acetate or goserelin acetate, or degarelix for up to 32 weeks

32 weeks

Regular visits for hormone administration

Stereotactic Body Radiation Therapy (SBRT)

Participants undergo 3-5 fractions of SBRT every 40 hours over 7-21 days

1-3 weeks

3-5 visits for radiation therapy

Radium Ra 223 Dichloride Treatment

Participants receive radium Ra 223 dichloride intravenously on day 1 of courses 2-7

6 months

6 visits for radium administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Goserelin Acetate
• Leuprolide Acetate
• Radium Ra 223 Dichloride
• Stereotactic Body Radiation Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment (hormone therapy, SBRT, radium Ra 223 dichloride) Experimental Treatment 6 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.

Goserelin Acetate is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Zoladex for:

• Breast cancer
• Prostate cancer
• Endometriosis
• Uterine fibroids

Approved in United States as Zoladex for:

• Advanced breast cancer
• Prostate cancer
• Endometriosis
• Uterine bleeding

Approved in Canada as Zoladex for:

• Breast cancer
• Prostate cancer
• Endometriosis

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

Published Research Related to This Trial

Radium-223 is an effective treatment for bone metastatic castration-resistant prostate cancer, improving overall survival and quality of life, as demonstrated in a Phase III randomized placebo-controlled study.

Unlike traditional chemotherapy, radium-223 specifically targets bone metastases and can be administered without complex shielding, making it a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolving treatment approaches for the management of metastatic castration-resistant prostate cancer - role of radium-223. Mukherji, D., El Dika, I., Temraz, S., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10845927/

Real-world effectiveness and safety of goserelin 10.8-mg ... Conclusions: Goserelin 10.8-mg depot effectively achieved and maintained castration and was well-tolerated in Chinese patients with localized ...

2. nejm.org nejm.org/doi/full/10.1056/NEJM199707313370502

Improved Survival in Patients with Locally Advanced ... Adjuvant treatment with goserelin, when started simultaneously with external irradiation, improves local control and survival in patients with locally advanced ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3004656/

Update on the management of prostate cancer with ... A randomized trial of 802 Australian men found that 3 months of neo-adjuvant ADT showed an inferior prostate cancer-specific mortality to men treated with 6 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/009042959180077K

Zoladex versus orchiectomy in treatmentof advanced ... These results suggest that Zoladex may offer an alternative to orchiectomy in the treatment of advanced prostate cancer.

5. journals.lww.com journals.lww.com/indianjcancer/fulltext/2022/59001/gonadotropin_releasing_hormone_agonists_in.12.aspx

Gonadotropin-releasing hormone agonists in prostate cancer When either goserelin or leuprolide was used, the 10-year OS rate was 62%. As an adjuvant to radical prostatectomy, goserelin had a 10-year survival rate of 87% ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05140512?term=goserelin&rank=8

Study Details | NCT05140512 | Pharmacokinetics, ... This is a randomized, open-label and parallel phase I study to compare pharmacokinetics (PK), pharmacodynamics (PD) and safety of goserelin acetate sustained- ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429596003007

Three-month depot of goserelin acetate: clinical efficacy ... For all patients, the median time to progression was 152.7 weeks and the median time to death was 213.6 weeks. The safety profile of the 10.8-mg goserelin ...