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

NCT03361735 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 2 other identifiers: 17085NCI-2017-02192
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Adenocarcinoma

Keywords

PSA Level Greater than or Equal to 0.2; Stage IV Prostate Adenocarcinoma AJCC v7

Outcome Measures

Primary Outcomes (2)

• Time to Treatment Failure

  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.

  Assessed up to 5 years

• Objective Response Rate

  Response will be evaluated in this study using the modified Prostate Cancer Working Group 2 criteria. Per Prostate Cancer Working Group 2 criteria for target lesions: Complete Response (CR), Disappearance of all target lesions. Lymph node CR is when the lymph node has decreased to less than 10mm in the short axis; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; For non-target lesions, CR: Disappearance of all non-target lesions and PSA level \<0.04 (undetectable). Overall Response (OR) = CR + PR. Proportion of patients achieving CR or PR at course 8, day 1 (post 6 doses of radium Ra 223 dichloride) were reported.

  Up to 5 years

Secondary Outcomes (8)

• Progression-free Survival

  From the initiation of ADT for metastatic disease until PSA progression or radiographic progression or death, assessed up to 5 years

• Overall Survival

  From date of initiation of protocol treatment to date of death from any cause, assessed up to 5 years

• Complete Response (CR) Rate Defined as the Proportion of Patients Achieving CR

  Up to 5 years

• Duration of Response

  From documented response to recurrent or progressive disease is first met, assessed up to 5 years

• Duration of Overall Complete Response

  From documented CR to recurrent/ progressive disease, assessed up to 5 years

Other Outcomes (3)

• Rate of Normalization of the Total Alkaline Phosphatase Level

  Baseline up to 5 years

• Genomic Mutations Analysis

  Up to 5 years

• Immune Biomarker Analysis

  Up to 5 years

Study Arms (1)

Treatment (hormone therapy, SBRT, radium Ra 223 dichloride)

EXPERIMENTAL

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.

Drug: Leuprolide Acetate; Drug: Goserelin Acetate; Radiation: Stereotactic Body Radiation Therapy; Radiation: Radium Ra 223 Dichloride; Other: Laboratory Biomarker Analysis; Drug: Degarelix

Interventions

Leuprolide Acetate DRUG

Intramuscular or subcutaneous injection

Also known as: 377526, 6-D-Leucine-9-(N-ethyl-L-prolinamide)-1-9-luteinizing Hormone-releasing Factor (Pig) Monoacetate, 6-D-Leucine-9-(N-ethyl-L-prolinamide)-10-deglycinamide Luteinizing Hormone-Releasing Factor (Pig) Monoacetate, 74381-53-6, A-43818, Abbott 43818, Abbott-43818, Carcinil, Depo-Eligard, Eligard, Enanton, Enantone, Enantone-Gyn, Ginecrin, LEUP, Leuplin, Leuprorelin Acetate, Lucrin, Lucrin Depot, Lupron, Lupron Depot, Lupron Depot-3 Month, Lupron Depot-4 Month, Lupron Depot-Ped, Procren, Procrin, Prostap, TAP-144, Trenantone, Uno-Enantone, Viadur

Treatment (hormone therapy, SBRT, radium Ra 223 dichloride)

Goserelin Acetate DRUG

Subcutaneous injection

Also known as: 606864, 65807-02-5, D-Ser(bu(t))(6)azgly(10)-LHRH Acetate, ZDX, Zoladex

Treatment (hormone therapy, SBRT, radium Ra 223 dichloride)

Radium Ra 223 Dichloride RADIATION

Given IV

Also known as: 444811-40-9, Alpharadin, BAY 88-8223, BAY88-8223, Radium 223 Dichloride, RADIUM CHLORIDE RA-223, Radium-223 Dichloride, Xofigo

Treatment (hormone therapy, SBRT, radium Ra 223 dichloride)

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Treatment (hormone therapy, SBRT, radium Ra 223 dichloride)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (hormone therapy, SBRT, radium Ra 223 dichloride)

Degarelix DRUG

Subcutaneous injection

Also known as: 214766-78-6, FE200486, Firmagon

Treatment (hormone therapy, SBRT, radium Ra 223 dichloride)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented informed consent of participant and/or legally authorized representative
• Agreement to provide archival primary or metastatic tumor tissue if available
• Eastern Cooperative Oncology Group (ECOG) =\< 2
• Life expectancy \> 12 months
• Histologic diagnosis of prostate adenocarcinoma
• \* Pure small cell carcinoma will be excluded; however, component of neuroendocrine /small cell differentiation will be allowed provided that adenocarcinoma constitutes majority of the tissue specimen
• Stage M1
• \* Metastatic disease can be documented by bone scan or computed tomography (CT) scan or magnetic resonance imaging (MRI) or positron emission tomography (PET)/CT or the combination of these tests
• Up to 4 metastatic lesions:
• Must have at least 1 bone lesion AND each non-visceral lesion should be less than 5 cm
• Visceral lesions will be limited to one lung lesion (\< 2 cm) or one lymph node; no liver lesions allowed; lymph nodes allowed provided they are not in a field of prior radiation, and if amenable to SBRT (to be reviewed by principal investigator \[PI\])
• Two lesions can be in close proximity (i.e. within 5 cm of each other) if they meet radiation SBRT normal tissue toxicity requirements
• If have untreated primary prostate cancer: must undergo debulking prostatectomy
• If had prior definitive radiation therapy to the prostate: no evidence of locally persistent or recurrent prostate cancer on digital rectal exam (DRE) and imaging studies (CT or MRI); retreatment to local residual-recurrent disease will result in potential eligibility to be reviewed by PI on a case-by-case basis
• Does not have castration resistant disease

You may not qualify if:

• Prior radium Ra 223 dichloride
• Prior or concomitant chemotherapy for metastatic or recurrent disease with the following exceptions:
• Prior chemotherapy for local primary disease is permitted
• Bisphosphonates or receptor activator of nuclear factor kappa-Β (RANK) ligand inhibitors are allowed at doses and schedule consistent with the treatment or prevention of osteoporosis
• Prior radiation treatment for metastatic disease
• Concomitant radiation treatment to primary prostate site
• Orchiectomy
• Unstable medical comorbidities (i.e. uncontrolled cardiac comorbidities)
• Metastases that in the judgment of investigator-radiologist are not amenable to SBRT
• History of brain metastases or who currently have treated or untreated brain metastases
• Uncontrolled human immunodeficiency virus (HIV) infection
• Any other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
• Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Interventions

Leuprolide; luprolide acetate gel depot; Goserelin; Radiosurgery; radium Ra 223 dichloride; acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Paul Frankel, Ph.D.
• Organization: City of Hope

pfrankel@coh.org

6262185265

Study Officials

• Savita Dandapani, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 5, 2017
• Study Start: August 29, 2018
• Primary Completion: March 21, 2024
• Study Completion (Estimated): January 6, 2027
• Last Updated: April 9, 2026
• Results First Posted: April 9, 2026

Record last verified: 2026-03

Locations

US (1)