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Gonadorelin

GnRH, Luteinizing Hormone-Releasing Hormone, LHRH, Factrel

Quick Stats
Studies 192
Trials 100
Active Not Recruiting PHASE2 INTERVENTIONAL NCT03361735

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This phase 2 trial studies radium Ra 223 dichloride, hormone therapy and stereotactic body radiation in treating patients with prostate cancer that has spread to other places in the body. Radium Ra 223 dichloride contains a radioactive substance that collects in the bone and gives off radiation that may kill cancer cells. Hormone therapy using leuprolide acetate or goserelin acetate may fight prostate cancer by lowering the amount of testosterone the body makes. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving radium Ra 223 dichloride, hormone therapy and stereotactic body radiation may work better at treating prostate cancer.

Detailed Description

PRIMARY OBJECTIVES: I. To assess the time to treatment failure (TTF) in patients who initiated the protocol regimen of androgen deprivation therapy (ADT) with stereotactic body radiation therapy (SBRT) and radium Ra 223 dichloride and received at least one dose with radium Ra 223 dichloride. SECONDARY OBJECTIVES: I. To assess the safety of adding radium Ra 223 dichloride to SBRT and ADT in patients with oligometastatic castration sensitive prostate cancer. II. To assess the prostate-specific antigen (PSA) and overall response rate (ORR) after 6 cycles of radium Ra 223 dichloride (cycle 8 day 1). III. To assess the progression-free survival (PFS) in patients with oligometastatic castration sensitive prostate cancer who initiated the protocol regimen of ADT with SBRT and radium Ra 223 dichloride and received at least one dose of radium Ra 223 dichloride. IV. To assess time to bone specific PFS in patients with oligometastatic castration sensitive prostate cancer who initiated the protocol regimen of ADT with SBRT and radium Ra 223 dichloride and received at least one dose of radium Ra 223 dichloride. V. To assess overall survival, complete response rate, duration of response, and duration of overall complete response and duration of stable disease in patients with oligometastatic castration sensitive prostate cancer who initiated the protocol regimen of ADT with SBRT and radium Ra 223 dichloride. VI. To assess long-term toxicities during 5-year follow-up in patients with oligometastatic castration sensitive prostate cancer who initiated the protocol regimen of ADT with SBRT and radium Ra 223 dichloride and received at least one dose of radium Ra 223 dichloride. TERTIARY OBJECTIVES: I. To perform exploratory analysis of primary or metastatic tumor mutation patterns in this study population at baseline. II. To identify immune system factors in the blood that change during the course of ADT-radiotherapy for metastatic prostate cancer. III. To describe the rate of normalization of the total alkaline phosphatase level (defined as a return to a value within the normal range) at the end of protocol therapy in patients oligometastatic castration sensitive prostate cancer with total alkaline phosphatase values above the upper limit of the normal range at baseline. OUTLINE: Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, or degarelix 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 intravenously (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. After completion of study treatment, patients are followed up for up to 5 years.

Interventions

Name: Leuprolide Acetate
Type: DRUG
Description: Intramuscular or subcutaneous injection
Name: Goserelin Acetate
Type: DRUG
Description: Subcutaneous injection
Name: Stereotactic Body Radiation Therapy
Type: RADIATION
Description: Undergo SBRT
Name: Radium Ra 223 Dichloride
Type: RADIATION
Description: Given IV
Name: Laboratory Biomarker Analysis
Type: OTHER
Description: Correlative studies
Name: Degarelix
Type: DRUG
Description: Subcutaneous injection

Primary Outcomes

Measure: Time to treatment failure
TimeFrame: Assessed up to 5 years
Description: Defined as time from the initiation of androgen deprivation therapy (ADT) for metastatic disease until PSA increase to \> pre-ADT level or PSA \> 10 (whichever is smaller) or radiographic or clinical progression or resumption of ADT by physician's choice.
Measure: Objective response rate
TimeFrame: Up to 5 years
Description: Response will be evaluated in this study using modified Prostate Cancer Working Group 2 criteria. Proportion of patients achieving complete response (CR) or partial response (PR) at course 8, day 1 (post 6 doses of radium Ra 223 dichloride).

Trial Information

NCT ID

NCT03361735

Status

Active Not Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

City of Hope Medical Center

Last Updated

December 15, 2025