<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03822494</url>
  </required_header>
  <id_info>
    <org_study_id>PCK-02</org_study_id>
    <nct_id>NCT03822494</nct_id>
  </id_info>
  <brief_title>CyberKnife Dose Escalation Prostate Cancer Trial</brief_title>
  <acronym>CK-DESPOT</acronym>
  <official_title>CyberKnife Dose Escalation for Unfavorable and High-risk Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Crozer-Keystone Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Crozer-Keystone Health System</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stereotactic body radiation therapy (SBRT) has been employed in the treatment of prostate&#xD;
      cancer. Multiple single institution experiences suggest high biochemical control rates with&#xD;
      acceptable toxicity in low risk prostate cancer but efficacy data in unfavorable type&#xD;
      prostate cancer is less convincing. CyberKnife-SBRT (CK-SBRT) can be used to escalate&#xD;
      radiation dose delivery to the prostate while sparing normal tissue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The optimal radiation schedule for the curative treatment of prostate cancer remains unknown.&#xD;
      Prostate cancer patients receiving radiation therapy are typically treated 5 days per week&#xD;
      for 8-9 weeks. Recent data suggest that large radiation fraction sizes are radio-biologically&#xD;
      favorable over lower fraction sizes in prostate cancer radiotherapy. The sensitivity of a&#xD;
      tumor or normal tissue to fraction size of radiation can be approximated by the alpha-beta&#xD;
      ratio. It has been suggested that the alpha/beta ratio for prostate cancer is actually as low&#xD;
      as 1.5 implying that the current radiation therapy paradigm for prostate cancer treatment&#xD;
      might be fundamentally flawed, as high fraction sizes would be expected to damage tumor more&#xD;
      readily.&#xD;
&#xD;
      Typical prostate SBRT doses do not appear to have similar efficacy in higher risk prostate&#xD;
      cancer suggesting even higher doses are required. Many techniques including dose escalated&#xD;
      external beam radiation therapy (EBRT), proton therapy (PT) and brachytherapy have been&#xD;
      employed to increase dose to the prostate. Data from the ASCEND-RT trial utilizing low dose&#xD;
      rate brachytherapy boost showed a dramatic 21% improvement in biochemical control at 9 years&#xD;
      favoring brachytherapy boost compared to conventional dose escalated EBRT radiation therapy.&#xD;
      However, no corresponding benefit was identified in overall survival, incidence of bone&#xD;
      metastases or prostate cancer specific mortality while a 3 fold increase in late urinary&#xD;
      toxicity was noted.&#xD;
&#xD;
      SBRT is well tolerated with minimal acute and late side effects. In this protocol, CK-SBRT&#xD;
      will be used to target the microscopic and gross disease in the prostate, seminal vesicles.&#xD;
      An escalated dose of 40 Gy in 5 fractions will be delivered to the entire target volume while&#xD;
      any nodules visible within the prostate gland on endorectal MRI will receive 50 Gy in 5&#xD;
      fractions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 12, 2018</start_date>
  <completion_date type="Anticipated">July 12, 2028</completion_date>
  <primary_completion_date type="Anticipated">July 12, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bladder and Rectal Toxicity using NCI common toxicity criteria version 4.0</measure>
    <time_frame>24 Months</time_frame>
    <description>Genitourinary or Bowel Toxicity as a result of radiation therapy will be reported using</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biochemical Disease Free Survival</measure>
    <time_frame>24 Months</time_frame>
    <description>Time in months from completion of SBRT to biochemical failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of local control</measure>
    <time_frame>24 Months</time_frame>
    <description>time in months from SBRT completion to local failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant Failure</measure>
    <time_frame>24 Months</time_frame>
    <description>time in months from SBRT completion to distant failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Free Survival</measure>
    <time_frame>24 Months</time_frame>
    <description>time in months from the date that the patient is determined to be free of disease to the date of known disease recurrence for any measure of disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Specific Survival</measure>
    <time_frame>24 Months</time_frame>
    <description>time in months from completion of SBRT to death due to prostate cancer, other causes with active malignancy, or complications from treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>5 years</time_frame>
    <description>ime in months from SBRT completion until death</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Prostate Adenocarcinoma</condition>
  <condition>Prostate Neoplasm</condition>
  <arm_group>
    <arm_group_label>Dose Escalated CyberKnife SBRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>CyberKnife SBRT</intervention_name>
    <description>Radiation Therapy</description>
    <arm_group_label>Dose Escalated CyberKnife SBRT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed adenocarcinoma of the prostate diagnosed within 360 days of&#xD;
             enrollment.&#xD;
&#xD;
          -  Prostate Specific Antigen (PSA) documented within 90 days prior to registration.&#xD;
&#xD;
          -  Clinical staging completed within 90 days of registration.&#xD;
&#xD;
          -  No Nodal or Distant Metastases documented on CT or MRI of the pelvis and bone scan.&#xD;
&#xD;
          -  Unfavorable Risk Prostate Carcinoma as Described is documented.&#xD;
&#xD;
          -  No prior pelvic radiotherapy.&#xD;
&#xD;
          -  No prior Trans-urethral resection of the prostate (TURP).&#xD;
&#xD;
          -  Prostate volume &lt; 100 cc&#xD;
&#xD;
          -  American Urologic Association (AUA) score &lt; 20&#xD;
&#xD;
          -  No recent (within 5 years) or concurrent cancers other than non-melanoma skin cancers.&#xD;
&#xD;
          -  Patient must have no medical or psychiatric illnesses that would interfere with&#xD;
             treatment or follow-up.&#xD;
&#xD;
          -  No implanted hardware adjacent to the prostate that would prohibit appropriate&#xD;
             treatment planning and treatment delivery is allowed.&#xD;
&#xD;
          -  Candidate for rectal spacer placement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other cancer diagnosis other than non-melanoma skin cancer with 5 years&#xD;
&#xD;
          -  Prostate size greater than 100cc&#xD;
&#xD;
          -  AUA greater than 20&#xD;
&#xD;
          -  Implanted hardware impacting imaging&#xD;
&#xD;
          -  Metastatic prostate cancer&#xD;
&#xD;
          -  Contraindication to hormone therapy&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Biological males with prostate cancer</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rachelle Lanciano, MD</last_name>
    <phone>610-446-6850</phone>
    <email>rachelle.lanciano@crozer.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michael Good, RN</last_name>
    <phone>610-446-6850</phone>
    <email>mgood@allianceoncology.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Crozer Keystone Health System/Philadelphia CyberKnife Center</name>
      <address>
        <city>Havertown</city>
        <state>Pennsylvania</state>
        <zip>19083</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shilecion Cooper, RN</last_name>
      <phone>610-446-6850</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>April 19, 2021</last_update_submitted>
  <last_update_submitted_qc>April 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Crozer-Keystone Health System</investigator_affiliation>
    <investigator_full_name>Rachelle Lanciano M.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>radiation therapy</keyword>
  <keyword>Cyberknife</keyword>
  <keyword>SBRT</keyword>
  <keyword>Protons</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03822494/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03822494
org study id: PCK-02
nct id: NCT03822494
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
Stereotactic body radiation therapy (SBRT) has been employed in the treatment of prostate
      cancer. Multiple single institution experiences suggest high biochemical control rates with
      acceptable toxicity in low risk prostate cancer but efficacy data in unfavorable type
      prostate cancer is less convincing. CyberKnife-SBRT (CK-SBRT) can be used to escalate
      radiation dose delivery to the prostate while sparing normal tissue.
The optimal radiation schedule for the curative treatment of prostate cancer remains unknown.
      Prostate cancer patients receiving radiation therapy are typically treated 5 days per week
      for 8-9 weeks. Recent data suggest that large radiation fraction sizes are radio-biologically
      favorable over lower fraction sizes in prostate cancer radiotherapy. The sensitivity of a
      tumor or normal tissue to fraction size of radiation can be approximated by the alpha-beta
      ratio. It has been suggested that the alpha/beta ratio for prostate cancer is actually as low
      as 1.5 implying that the current radiation therapy paradigm for prostate cancer treatment
      might be fundamentally flawed, as high fraction sizes would be expected to damage tumor more
      readily.

      Typical prostate SBRT doses do not appear to have similar efficacy in higher risk prostate
      cancer suggesting even higher doses are required. Many techniques including dose escalated
      external beam radiation therapy (EBRT), proton therapy (PT) and brachytherapy have been
      employed to increase dose to the prostate. Data from the ASCEND-RT trial utilizing low dose
      rate brachytherapy boost showed a dramatic 21% improvement in biochemical control at 9 years
      favoring brachytherapy boost compared to conventional dose escalated EBRT radiation therapy.
      However, no corresponding benefit was identified in overall survival, incidence of bone
      metastases or prostate cancer specific mortality while a 3 fold increase in late urinary
      toxicity was noted.

      SBRT is well tolerated with minimal acute and late side effects. In this protocol, CK-SBRT
      will be used to target the microscopic and gross disease in the prostate, seminal vesicles.
      An escalated dose of 40 Gy in 5 fractions will be delivered to the entire target volume while
      any nodules visible within the prostate gland on endorectal MRI will receive 50 Gy in 5
      fractions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Bladder and Rectal Toxicity using NCI common toxicity criteria version 4.0
time frame: 24 Months
description: Genitourinary or Bowel Toxicity as a result of radiation therapy will be reported using
measure: Biochemical Disease Free Survival
time frame: 24 Months
description: Time in months from completion of SBRT to biochemical failure
measure: Duration of local control
time frame: 24 Months
description: time in months from SBRT completion to local failure
measure: Distant Failure
time frame: 24 Months
description: time in months from SBRT completion to distant failure
measure: Disease Free Survival
time frame: 24 Months
description: time in months from the date that the patient is determined to be free of disease to the date of known disease recurrence for any measure of disease.
measure: Disease Specific Survival
time frame: 24 Months
description: time in months from completion of SBRT to death due to prostate cancer, other causes with active malignancy, or complications from treatment.
measure: Overall Survival
time frame: 5 years
description: ime in months from SBRT completion until death
arm group label: Dose Escalated CyberKnife SBRT
arm group type: Experimental
intervention type: Radiation
intervention name: CyberKnife SBRT
description: Radiation Therapy
arm group label: Dose Escalated CyberKnife SBRT
criteria: 
gender: Male
gender based: Yes
gender description: Biological males with prostate cancer
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rachelle Lanciano, MD
phone: 610-446-6850
email: rachelle.lanciano@crozer.org
last name: Michael Good, RN
phone: 610-446-6850
email: mgood@allianceoncology.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Crozer-Keystone Health System
investigator full name: Rachelle Lanciano M.D.
investigator title: Principal Investigator
mesh term: Prostatic Neoplasms
sharing ipd: No
provided document: 