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A Study of Stereotactic Body Radiation Therapy and Radium (Ra-223) Dichloride in Prostate Cancer That Has Spread to the Bones

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05133440
Recruitment Status : Recruiting
First Posted : November 24, 2021
Last Update Posted : June 2, 2023
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
Participants will either receive treatment with standard SBRT and the study drug Radium (Ra-223) dichloride, or standard SBRT alone.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Radium dichloride Diagnostic Test: PET Scan Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SAXON-PC: A Phase II Randomized Trial of Stereotactic Body Radiation Therapy (SBRT) And Radium (Ra-223) Dichloride for Oligorecurrent, Non-castrate Resistant Prostate Cancer
Actual Study Start Date : November 12, 2021
Estimated Primary Completion Date : November 12, 2027
Estimated Study Completion Date : November 12, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Arm
Participants will receive two cycles of Radium (Ra-223) dichloride at 55 kBq/kg or 0.00149 mCi/kg or 1.49 uCi/kg every 4 weeks followed 2-3 weeks later by SBRT at a dose of 9 Gy per fraction for 3 fractions (total dose of 27 Gy) to all sites of radiographically apparent metastatic disease.
 Drug: Radium dichloride
Two cycles of Radium (Ra-223) dichloride at 55 kBq/kg or 0.00149 mCi/kg or 1.49 uCi/kg every 4 weeks followed 2-3 weeks later by SBRT at a dose of 9 Gy per fraction for 3 fractions (total dose of 27 Gy) to all sites of radiographically apparent metastatic disease. SBRT fractions can be administered every day or every other day per institutional practice. An additional 4 cycles of Radium (Ra-223) dichloride at 55 kBq/kg or 0.00149 mCi/kg or 1.49 uCi/kg every 4 weeks will then be administered, resuming 2-3 weeks after completion of the final fraction of SBRT.
Other Name: Ra-223
Active Comparator: Control Arm:
Participants will receive SBRT at a dose of 9 Gy per fraction for 3 fractions (total dose of 27 Gy) to all sites of radiographically apparent metastatic disease. SBRT fractions can be administered every day or every other day per institutional practice.
 Drug: Radium dichloride
Two cycles of Radium (Ra-223) dichloride at 55 kBq/kg or 0.00149 mCi/kg or 1.49 uCi/kg every 4 weeks followed 2-3 weeks later by SBRT at a dose of 9 Gy per fraction for 3 fractions (total dose of 27 Gy) to all sites of radiographically apparent metastatic disease. SBRT fractions can be administered every day or every other day per institutional practice. An additional 4 cycles of Radium (Ra-223) dichloride at 55 kBq/kg or 0.00149 mCi/kg or 1.49 uCi/kg every 4 weeks will then be administered, resuming 2-3 weeks after completion of the final fraction of SBRT.
Other Name: Ra-223

Diagnostic Test: PET Scan
For both arms, the NaF PET will be used to identify discrete osseous lesions which will become index lesions for the study. The simulation scan (either baseline or after 2 cycles of Ra-223) will be used to generate a suitable SBRT radiation plan, per standard practice. If the index lesions are no longer visible after two cycles of Ra-223, we still intend to consolidate the area with radiation. If the lesions are initially radio-occult on the CT and only visible on the NaF PET, we will fuse the pre-treatment NaF PET/CT to the simulation CT after 2 cycles of Ra-223 to delineate the SBRT treatment volumes.
Other Name: NaF PET


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 1 year ]
    The primary outcome is to compare rates of composite PFS between the two treatment arms using bone scan imaging. A patient will be considered to have disease progression if any of the following events occur from the time of protocol randomization to date of last follow-up: a) PSA biochemical progression OR b) Radiographical progression OR c) clinical progression OR d) start of ADT OR e) death from any cause


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven prostate adenocarcinoma
  • ≥ 18 years old
  • Primary prostate tumor must have been treated with prior prostatectomy or definitive radiotherapy
  • Men with prior salvage radiotherapy to the prostate bed and/or locoregional lymph nodes are eligible assuming normalization of testosterone
  • Negative multi-parametric MRI and/or negative biopsy of the prostate (or prostate bed) within 60 days of enrollment
  • Pre-enrollment imaging (any bone imaging modality per institutional standard of care) demonstrates oligometastatic disease with 1-3 discrete metastatic lesions of the bone performed within 60 days of study enrollment; screening PSMA PET confirming 1-3 sites of oligometastatic disease performed within 60 days of enrollment.
  • All bony oligometastatic sites must be deemed appropriate to receive 3 fraction SBRT to a dose of 9 Gy x 3 at best judgment of treating radiation oncologist
  • Prostate specific antigen (PSA) ≥ 0.5 ng/mL but ≤ 50 ng/mL
  • Patients may have had prior androgen deprivation therapy (ADT) but must have normal testosterone levels (>100 ng/dL) at time of enrollment; patients with baseline low testosterone but no ADT exposure are eligible
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Subjects who have not had surgical removal of their prostate and have a partner of child bearing potential must agree to use condoms beginning at the signing of the consent until at least 6 months after the last dose of study drug. Because of the potential side effect on spermatogenesis associated with radiation, female partners of childbearing potential must agree to use a highly effective contraceptive method during and for 6 months after completing treatment. Examples of highly effective contraception options for women include implantable uterine devices (hormonal or non-hormonal), oral, patch and parenteral contraceptives (when taken as prescribed).

  • Adequate hematological, liver and renal function

    • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
    • Platelet count ≥ 100 x 10^9/L
    • Hemoglobin ≥ 10.0 g/dL
    • Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
    • Creatinine ≤ 1.5 x ULN with normal creatinine clearance
    • Albumin > 25 g/L
  • Patient willing and able to comply with the protocol, including follow-up visits and examination

Exclusion Criteria:

  • Pathological findings consistent with small cell and/or neuroendocrine carcinoma of the prostate or any other histology
  • Any metastatic site >5 cm in maximum diameter
  • Patients with documented castration resistant prostate cancer (CRPC)
  • Patients with any form of conventional, metabolic or molecular imaging (including PET imaging with PSMA, fluciclovine and/or FDG tracers) within 60 days of enrollment that demonstrate more than 3 discrete metastatic lesions
  • Patients with evidence of nonpelvic lymph nodal or any visceral metastases
  • Patients with evidence of progressing locoregional lymph nodes (prior lymphadenectomy or definitive/salvage RT to the pelvic lymph nodes is acceptable assuming no evidence of progression)
  • Patients with documented or suspected impending significant spinal cord compression defined as epidural spinal cord compression (ESCC) grade 2 or higher using the Bilsky scale
  • Patients with parenchymal brain metastases
  • Patient received any other investigational therapeutic agents or other anticancer therapeutics within 4 weeks prior to randomization
  • Major surgery within 30 days prior to start of study drug
  • Any prior systemic therapy with radionuclide agents (e.g., strontium-89, samarium-153, rhenium-186, rhenium-188 or Radium (Ra-223) dichloride) for the treatment of bony metastases
  • Fecal incontinence
  • History of another malignancy within the previous 3 years except for the following:

adequately treated basal cell or squamous cell skin cancer

  • Any other serious illness or medical condition, such as but not limited to:

    • Any infection greater than National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 5.0 Grade 2
    • New York Heart Association (NYHA) Class III or IV heart failure
    • Crohn's disease or ulcerative colitis
    • Bone marrow dysplasia or myelodysplastic syndrome
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05133440


Contacts
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Contact: Michael Zelefsky, MD 2126396802 zelefskm@MSKCC.ORG
Contact: Michael Morris, MD 646-422-4469 morrism@MSKCC.ORG

Locations
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United States, Colorado
University of Colorado (Data Collection Only) Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Tyler Robin, MD, PhD    720-848-0100      
United States, New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Michael Zelefsky, MD    212-639-6802      
Memoral Sloan Kettering Monmouth (Limited Protocol Activities) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Michael Zelefsky, MD    212-639-6802      
Memorial Sloan Kettering Bergen (Limited Protocol Activities) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Michael Zelefsky, MD    212-639-6802      
United States, New York
Memorial Sloan Kettering Commack (Limited Protocol Activities) Recruiting
Commack, New York, United States, 11725
Contact: Michael Zelefsky, MD    212-639-6802      
Memorial Sloan Kettering Westchester (Limited Protocol Activities) Recruiting
Harrison, New York, United States, 10604
Contact: Michael Zelefsky, MD    212-639-6802      
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Michael Zelefsky, MD    212-639-6802      
Principal Investigator: Michael Zelefsky, MD         
Associated Medical Professionals (Data collection only) Not yet recruiting
Syracuse, New York, United States, 13210
Contact: Christopher Pieczonka, MD    315-478-4185      
United States, Ohio
Cleveland Clinic (Data Collection Only) Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Rahul Tendulkar, MD    216-444-2200      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Michael Zelefsky, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT05133440    
Other Study ID Numbers: 21-213
First Posted: November 24, 2021    Key Record Dates
Last Update Posted: June 2, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Prostate Cancer
SBRT
Non-castrate Resistant Prostate Cancer
Oligorecurrent Prostate Cancer
 SAXON-PC
21-213
Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases