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Prostate AdenocarcinomaPhase 2NCT03361735

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

A Phase 2 study testing Leuprolide Acetate, Goserelin Acetate and Stereotactic Body Radiation Therapy in people with Prostate Adenocarcinoma, run by City of Hope Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Prostate Adenocarcinoma
What is being tested?
Leuprolide Acetate, Goserelin Acetate and Stereotactic Body Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
29 Aug 2018to 6 Jan 2027
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

Official title: A Phase 2 Trial of Radium Ra 223 Dichloride in Combination With Androgen Deprivation Therapy and Stereotactic Body Radiation Therapy for Patients With Oligometastatic Castration Sensitive Prostate Cancer

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

  1. 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:

  1. 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.

Being tested
Leuprolide Acetate, Goserelin Acetate, Stereotactic Body Radiation Therapy, Radium Ra 223 Dichloride, Laboratory Biomarker Analysis
Keywords
PSA Level Greater than or Equal to 0.2, Stage IV Prostate Adenocarcinoma AJCC v7

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Leuprolide AcetateDrug

    Also called 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

    Intramuscular or subcutaneous injection

  • Goserelin AcetateDrug

    Also called 606864, 65807-02-5, D-Ser(bu(t))(6)azgly(10)-LHRH Acetate, ZDX

    Subcutaneous injection

  • Stereotactic Body Radiation TherapyRadiation

    Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

    Undergo SBRT

  • Radium Ra 223 DichlorideRadiation

    Also called 444811-40-9, Alpharadin, BAY 88-8223, BAY88-8223

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • DegarelixDrug

    Also called 214766-78-6, FE200486, Firmagon

    Subcutaneous injection

Study groups in NCT03361735
Study groupRoleWhat they receive
Treatment (hormone therapy, SBRT, radium Ra 223 dichloride)ExperimentalBeginning 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.
Receives: Drug: Leuprolide Acetate; Drug: Goserelin Acetate; Radiation: Stereotactic Body Radiation Therapy; Radiation: Radium Ra 223 Dichloride; Other: Laboratory Biomarker Analysis; Drug: Degarelix

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Assessed up to 5 years

  2. 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.

    Measured: Up to 5 years

Secondary outcomes (8)

  1. Progression-free Survival

    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.

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

  2. Overall Survival

    Measured: 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

    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).

    Measured: Up to 5 years

  4. Duration of Response

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

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

  5. Duration of Overall Complete Response

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

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

  6. Bone Specific Progression-free Survival

    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.

    Measured: Time to progression of bone specific disease over baseline, assessed up to 5 years

  7. Duration of Stable Disease

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

    Measured: 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

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

    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.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2017
  2. Study start29 Aug 2018
  3. Primary completion21 Mar 2024
  4. Study completion6 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03361735
Sponsor's protocol ID
17085
Other IDs
NCI-2017-02192
Status last verified
Mar 2026
First submitted
29 Nov 2017
Last updated
9 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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