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Trial · Interventional

Active, not recruitingPhase 2Results postedRegistry data

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

NCTNCT03361735 (opens ClinicalTrials.gov in a new tab)Other id17085Other idNCI-2017-02192

Overview

Status
Active, not recruiting
Phase
Phase 2
Enrollment
25 participants (actual)
Sponsor
City of Hope Medical Center · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
29 Aug 2018
Primary completion
21 Mar 2024
Completion
6 Jan 2027 (estimated)
First posted
5 Dec 2017
Last update posted
9 Apr 2026
Conditions
Prostate Adenocarcinoma

Timeline

1 trial · 1 ongoing · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201820202022202420262028
  1. Ph 2

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

    NCT03361735

    29 Aug 2018 to est. 6 Jan 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Leuprolide AcetateDrug
  • Goserelin AcetateDrug
  • Stereotactic Body Radiation TherapyRadiation
  • Radium Ra 223 DichlorideRadiation
  • Laboratory Biomarker AnalysisOther
  • DegarelixDrug

Arms1

  • Experimental

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

    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.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Time to Treatment Failure

    Time frame · Assessed up to 5 years

    Registry 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.

  2. Objective Response Rate

    Time frame · Up to 5 years

    Registry description

    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.

Secondary outcomes(8)
  1. Progression-free Survival

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

    Registry description

    Progression 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: Progressive Disease (PD), At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started (including the baseline scan if that is the smallest), and at least a 5mm increase or the appearance of new lesions; For non-target lesions, PD: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PSA increase by ≥ 25 % over baseline and to at least PSA \>2 ng/mL.

  2. Overall Survival

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

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

    Time frame · Up to 5 years

    Registry description

    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; For non-target lesions, CR: Disappearance of all non-target lesions and PSA level \<0.04 (undetectable).

  4. Duration of Response

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

    Registry description

    Response will be evaluated in this study using modified Prostate Cancer Working Group 2 criteria.

  5. Duration of Overall Complete Response

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

    Registry description

    Response will be evaluated in this study using modified Prostate Cancer Working Group 2 criteria.

  6. Bone Specific Progression-free Survival

    Time frame · Time to progression of bone specific disease over baseline, assessed up to 5 years

    Registry description

    Progression will be evaluated in this study using modified Prostate Cancer Working Group 2 criteria. Progression 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: Progressive Disease (PD), At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started (including the baseline scan if that is the smallest), and at least a 5mm increase or the appearance of new lesions; For non-target lesions, PD: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PSA increase by ≥ 25 % over baseline and to at least PSA \>2 ng/mL.

  7. Duration of Stable Disease

    Time frame · Time from start of treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, assessed up to 5 years

    Registry description

    Response will be evaluated in this study using modified Prostate Cancer Working Group 2 criteria.

  8. Number of Participants With Adverse Events (AE) Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

    Time frame · Up to 5 years

    Registry description

    Toxicity will be graded. The highest AE grade per cycle will be reported in the electronic case report form (eCRF) from start of therapy until the end of treatment visit.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Assessed up to 5 years

Time to Treatment Failure

GroupValue (months)
De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride)42.1
Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride)17.0
Primary outcomeCount of participants· Up to 5 years

Objective Response Rate

GroupValue (Participants)
De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride)0
Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride)0
Secondary and other outcome results(6)
Secondary outcomeMedian· From the initiation of ADT for metastatic disease until PSA progression or radiographic progression or death, assessed up to 5 years

Progression-free Survival

GroupValue (months)
De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride)42.1
Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride)17.8
Secondary outcomeMedian· From date of initiation of protocol treatment to date of death from any cause, assessed up to 5 years

Overall Survival

GroupValue (months)
De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride)NA
Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride)NA
Secondary outcomeCount of participants· Up to 5 years

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

GroupValue (Participants)
De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride)0
Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride)0
Secondary outcome· From documented response to recurrent or progressive disease is first met, assessed up to 5 years

Duration of Response

GroupValue
De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride)not posted
Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride)not posted
Secondary outcome· From documented CR to recurrent/ progressive disease, assessed up to 5 years

Duration of Overall Complete Response

GroupValue
De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride)not posted
Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride)not posted
Secondary outcomeMedian· Time to progression of bone specific disease over baseline, assessed up to 5 years

Bone Specific Progression-free Survival

GroupValue (months)
De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride)34.3
Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride)NA

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride)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. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection1 / 60 / 66 / 6
Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride)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. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection5 / 180 / 1818 / 18

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 \* Castration resistance defined as progression of disease despite serum testosterone level of \< 50 ng/dL * PSA \>= 0.2 prior to start of androgen deprivation treatment * Initiated 28 (+ 7) days of androgen deprivation therapy (ADT) prior to day 1 of protocol therapy \* Only luteinizing hormone-releasing hormone (LHRH) agonist/antagonist treatment is considered ADT, bicalutamide or other antiandrogens used alone do not count * May have received prior hormonal therapy in the context of definitive treatment of a primary tumor \* Patients may have had one prior systemic non-chemotherapeutic treatment (i.e. immunotherapy, receptor tyrosine kinase inhibitor, antiangiogenic agent, differentiating agent) for recurrent or metastatic disease * Must have refused standard of care chemotherapy for metastatic disease * Recovered from all acute side-effects (except alopecia) related to previous systemic therapy * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 (to be performed within 14 days prior to day 1 of protocol therapy) \* NOTE: growth factor support is not permitted to normalize baseline ANC parameters, however subsequent growth factor administration is permitted as standard supportive care * Platelets \>= 100,000/mm\^3 (to be performed within 14 days prior to day 1 of protocol therapy) \* NOTE: transfusion of blood products are not allowed to normalize baseline blood parameters, however subsequent transfusions are allowed per standard supportive care guidelines * Hemoglobin (HgB) \>= 9.0 g/dL (to be performed within 14 days prior to day 1 of protocol therapy) \* NOTE: transfusion of blood products are not allowed to normalize baseline blood parameters, however subsequent transfusions are allowed per standard supportive care guidelines * 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) * Alanine aminotransferase (ALT) =\< 2.5 x ULN (to be performed within 14 days prior to day 1 of protocol therapy) * Creatinine =\< 2.5 mg/dL (to be performed within 14 days prior to day 1 of protocol therapy) Exclusion Criteria: * 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)

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