<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/NCT03753334</url>
  </required_header>
  <id_info>
    <org_study_id>2017-3407</org_study_id>
    <nct_id>NCT03753334</nct_id>
  </id_info>
  <brief_title>Effects of EPA in Men With Biochemical Recurrence or Progression of Prostate Cancer.</brief_title>
  <acronym>RCT-EPAII-BCR</acronym>
  <official_title>Étude Pilote randomisée de Phase IIB, contrôlée Par placébo, évaluant l'Effet thérapeutique d'Une supplémentation en Omega-3 (Principalement EPA) Chez Des Patients en récidive Biochimique ou en Progression du Cancer de la Prostate.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CHU de Quebec-Universite Laval</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CHU de Quebec-Universite Laval</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prostate cancer biochemical recurrence (BCR) occurs in 20-50% of patients following radical&#xD;
      prostatectomy or radiotherapy. Due to significant risk of side effects and uncertainty about&#xD;
      the benefits, physicians and patients are seeking alternatives to delay androgen deprivation&#xD;
      therapy (ADT) for non-metastatic BCR. Long-chain omega-3 fatty acids (LCn3), mainly found in&#xD;
      seafood and fatty fish, have beneficial effects against prostate cancer in pre-clinical&#xD;
      experimental studies and randomized clinical trials of intermediate prostate cancer outcomes.&#xD;
      The current observational evidence also supports testing LCn3 in prostate cancer patients.&#xD;
      LCn3 have beneficial effects on inflammation, cardiovascular, psychological, and other&#xD;
      outcomes, contrasting sharply with ADT-associated side effects.&#xD;
&#xD;
      Investigators propose to conduct a pilot randomized placebo-controlled trial to determine the&#xD;
      effects over one year of an innovative LCn3 supplement (5g of omega-3-rich fish oil daily,&#xD;
      including 4g of monoglycerides eicosapentaenoic acid (MAG-EPA)) in 40 men experiencing BCR or&#xD;
      prostate cancer progression after a curative treatment.&#xD;
&#xD;
      This project proposes a simple intervention by dietary supplementation that could eventually&#xD;
      help to prevent or delay ADT-related side effects and thus could contribute to diminish the&#xD;
      heavy individual and societal burden of prostate cancer. The clinical data generated by this&#xD;
      pilot trial will serve as basis for a larger-scale phase II clinical trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 10, 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prostate-specific antigen (PSA) doubling time from baseline to 12 months.</measure>
    <time_frame>12 months</time_frame>
    <description>Efficacy of a one-year MAG-EPA supplementation versus placebo on PSA kinetics will be evaluated based on the comparison of PSA doubling time from baseline to 12 months. The investigators will measure PSA level every three months and calculate PSA doubling time at 12 months (using a linear regression approach) after randomisation using the randomisation PSA value as the starting point. PSA slope will be defined as the linear regression line of the natural log of PSA (in ng/mL) against time (in months). PSA doubling time will be defined as the natural log of 2 divided by the PSA slope.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fatty acid profiles in red blood cells, changes relative to baseline (time 0).</measure>
    <time_frame>3, 6, 9,12 months</time_frame>
    <description>The changes of fatty acid levels in red blood cell membranes, relative to their baseline levels, will be measured every three months. The profile of fatty acids will be quantified using gas chromatography coupled with mass spectrometry and expressed as relative percentages of total fatty acids.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>MAG-EPA group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5g/day of omega-3-rich fish oil capsules, which include 4g of purified EPA, to be taken once a day, for 12 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>5g/day of high-oleic sunflower oil capsules, to be taken once a day, for 12 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>MAG-EPA</intervention_name>
    <description>5g/day of omega-3-rich fish oil including 4g of purified monoglycerides EPA, capsules, taken once daily, for 12 months</description>
    <arm_group_label>MAG-EPA group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo group</intervention_name>
    <description>5g/day of placebo (high oleic sunflower oil), capsules, taken once daily, for 12 months</description>
    <arm_group_label>Placebo group</arm_group_label>
    <other_name>High oleic sunflower oil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have a histologically or cytologically confirmed history of&#xD;
             adenocarcinoma of the prostate.&#xD;
&#xD;
          -  Patients must have a PSA failure defined as PSA of &gt;= 0.5 ng/ml that has increased&#xD;
             above nadir following radical prostatectomy (RP); or a PSA increase of 2.0 above&#xD;
             post-therapy nadir after radiotherapy (RT); or a PSA increase between 0.05-0.49 ng/ml&#xD;
             that has increased above nadir following RP. The maximal PSA value at enrolment must&#xD;
             be &lt;5.0 ng/mL after RP and &lt;6 ng/mL after RT.&#xD;
&#xD;
          -  PSA value must be increasing based on three consecutive measurements each separated by&#xD;
             at least 4 weeks prior to enrolment to this study.&#xD;
&#xD;
          -  Patients may have received any number of local therapies (RP, external beam RT or&#xD;
             brachytherapy).&#xD;
&#xD;
          -  Provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with evidence of metastatic disease.&#xD;
&#xD;
          -  Patients who have received prior cytotoxic chemotherapy for recurrent disease.&#xD;
&#xD;
          -  Patients currently receiving biological response modifiers, or corticosteroids.&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness or social situations that would limit compliance&#xD;
             with study requirements.&#xD;
&#xD;
          -  Use of omega-3 or any other dietary supplements for the previous 3 months and during&#xD;
             study is not allowed.&#xD;
&#xD;
          -  Known allergy to fish or shellfish or sunflower.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vincent Fradet, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Québec-Univeristé Laval</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vincent Fradet, MD, PhD</last_name>
    <phone>418-525-4444</phone>
    <phone_ext>15561</phone_ext>
    <email>vincent.fradet@fmed.ulaval.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Carole Plante, Inf</last_name>
    <phone>418-691-5050</phone>
    <email>carole.plante@crchudequebec.ulaval.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre de Recherche Clinique et Évaluative en Oncologie - Hôtel-Dieu de Québec</name>
      <address>
        <city>Québec</city>
        <state>Quebec</state>
        <zip>G1R 3S1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vincent Fradet, MD, PhD</last_name>
      <phone>418-525-4444</phone>
      <phone_ext>15561</phone_ext>
      <email>vincent.fradet@fmed.ulaval.ca</email>
    </contact>
    <contact_backup>
      <last_name>Carole Plante, Inf</last_name>
      <phone>418-691-5050</phone>
      <email>Carole.Plante@crchudequebec.ulaval.ca</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>March 15, 2022</last_update_submitted>
  <last_update_submitted_qc>March 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Biochemical recurrence (BCR)</keyword>
  <keyword>Androgen-deprivation therapy (ADT)</keyword>
  <keyword>PSA doubling time</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Omega-3 fatty acids</keyword>
  <keyword>Biomarkers</keyword>
  <keyword>Prostate cancer progression</keyword>
  <keyword>PSA kinetics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Disease Progression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03753334
org study id: 2017-3407
nct id: NCT03753334
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Prostate cancer biochemical recurrence (BCR) occurs in 20-50% of patients following radical
      prostatectomy or radiotherapy. Due to significant risk of side effects and uncertainty about
      the benefits, physicians and patients are seeking alternatives to delay androgen deprivation
      therapy (ADT) for non-metastatic BCR. Long-chain omega-3 fatty acids (LCn3), mainly found in
      seafood and fatty fish, have beneficial effects against prostate cancer in pre-clinical
      experimental studies and randomized clinical trials of intermediate prostate cancer outcomes.
      The current observational evidence also supports testing LCn3 in prostate cancer patients.
      LCn3 have beneficial effects on inflammation, cardiovascular, psychological, and other
      outcomes, contrasting sharply with ADT-associated side effects.

      Investigators propose to conduct a pilot randomized placebo-controlled trial to determine the
      effects over one year of an innovative LCn3 supplement (5g of omega-3-rich fish oil daily,
      including 4g of monoglycerides eicosapentaenoic acid (MAG-EPA)) in 40 men experiencing BCR or
      prostate cancer progression after a curative treatment.

      This project proposes a simple intervention by dietary supplementation that could eventually
      help to prevent or delay ADT-related side effects and thus could contribute to diminish the
      heavy individual and societal burden of prostate cancer. The clinical data generated by this
      pilot trial will serve as basis for a larger-scale phase II clinical trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Prostate-specific antigen (PSA) doubling time from baseline to 12 months.
time frame: 12 months
description: Efficacy of a one-year MAG-EPA supplementation versus placebo on PSA kinetics will be evaluated based on the comparison of PSA doubling time from baseline to 12 months. The investigators will measure PSA level every three months and calculate PSA doubling time at 12 months (using a linear regression approach) after randomisation using the randomisation PSA value as the starting point. PSA slope will be defined as the linear regression line of the natural log of PSA (in ng/mL) against time (in months). PSA doubling time will be defined as the natural log of 2 divided by the PSA slope.
measure: Fatty acid profiles in red blood cells, changes relative to baseline (time 0).
time frame: 3, 6, 9,12 months
description: The changes of fatty acid levels in red blood cell membranes, relative to their baseline levels, will be measured every three months. The profile of fatty acids will be quantified using gas chromatography coupled with mass spectrometry and expressed as relative percentages of total fatty acids.
arm group label: MAG-EPA group
arm group type: Experimental
description: 5g/day of omega-3-rich fish oil capsules, which include 4g of purified EPA, to be taken once a day, for 12 months.
arm group label: Placebo group
arm group type: Placebo Comparator
description: 5g/day of high-oleic sunflower oil capsules, to be taken once a day, for 12 months.
intervention type: Combination Product
intervention name: MAG-EPA
description: 5g/day of omega-3-rich fish oil including 4g of purified monoglycerides EPA, capsules, taken once daily, for 12 months
arm group label: MAG-EPA group
intervention type: Dietary Supplement
intervention name: Placebo group
description: 5g/day of placebo (high oleic sunflower oil), capsules, taken once daily, for 12 months
arm group label: Placebo group
other name: High oleic sunflower oil
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Vincent Fradet, MD, PhD
role: Principal Investigator
affiliation: CHU de Québec-Univeristé Laval
last name: Vincent Fradet, MD, PhD
phone: 418-525-4444
phone ext: 15561
email: vincent.fradet@fmed.ulaval.ca
last name: Carole Plante, Inf
phone: 418-691-5050
email: carole.plante@crchudequebec.ulaval.ca
facility: 
status: Recruiting
contact: 
contact backup: 
country: Canada
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Disease Progression
sharing ipd: Undecided