<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/NCT02995330</url>
  </required_header>
  <id_info>
    <org_study_id>J1608</org_study_id>
    <secondary_id>IRB00086105</secondary_id>
    <nct_id>NCT02995330</nct_id>
  </id_info>
  <brief_title>Sex-Mismatched Allogeneic Bone Marrow Transplantation for Men With Metastatic Castration-Resistant Prostate Cancer</brief_title>
  <official_title>A Pilot Study of Sex-Mismatched Allogeneic Bone Marrow Transplantation for Men With Metastatic Castration-Resistant Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Men with progressive metastatic Castration-Resistant Prostate Cancer post first-line&#xD;
      treatment with either androgen deprivation therapy alone or androgen deprivation therapy plus&#xD;
      docetaxel who have an identified related female donor (mother sister, daughter, second degree&#xD;
      relative such as granddaughter or niece) will undergo bone marrow transplantation followed by&#xD;
      post-transplant Cytoxan (PT/Cy) and testosterone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Men will undergo pre-transplant screening evaluation and be enrolled in the study. Subjects&#xD;
      will be treated with a standard non-myeloablative conditioning regimen consisting of&#xD;
      Fludarabine 30 mg/m2 IV Days -6 to -2; Cy 14.5 mg/kg IV Days -6 and -5; Total body&#xD;
      irradiation (TBI) 200 cGy Day -1. On Day 0, patients will be infused with non-T-cell depleted&#xD;
      bone marrow from a related female donor. Patients will receive GVHD prophylaxis consisting&#xD;
      of: Cy 50mg/kg IV on Days +3 and +4; tacrolimus (IV or PO) beginning on Day +5 [dose adjusted&#xD;
      to maintain trough level of 5-15 ng/mL] through day+180; Mycophenolate mofetil (MMF) 15 mg/kg&#xD;
      PO TID, with a maximum dose of 1g TID beginning on Day +5 through Day +35. Patients will&#xD;
      receive filgrastim (G-CSF) 5 mcg/kg/day beginning on Day +5 and continued until ANC ≥&#xD;
      1500/mm3. Lastly, to produce maintenance tumor antigen stimulation, patients will be&#xD;
      maintained on continuous LHRH agonist/antagonist therapy (if not previously surgically&#xD;
      castrated) to suppress endogenous testosterone production throughout the treatment period;&#xD;
      testosterone cypionate 400 mg IM will be administered on Day +60, +90, and +120 (every 30&#xD;
      days x 3 doses). Patients who achieve biochemical CR will stop LHRH agonist/antagonist&#xD;
      treatment at day 180. Patients will be followed for 3 years post-BMT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    lack of accrual&#xD;
  </why_stopped>
  <start_date type="Actual">February 9, 2017</start_date>
  <completion_date type="Actual">June 16, 2021</completion_date>
  <primary_completion_date type="Actual">June 16, 2021</primary_completion_date>
  <phase>Phase 1</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>PSA response</measure>
    <time_frame>6 months</time_frame>
    <description>Percentage of participants with complete biochemical response at 6 months post-transplant (PSA &lt;0.1 ng/mL for patients post-prostatectomy and PSA &lt; 1 ng/mL for patients post-radiation therapy)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Transplant-related mortality</measure>
    <time_frame>3 years</time_frame>
    <description>Number of participants who experience transplant-related mortality (TRM) following alloBMT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PSA response rate</measure>
    <time_frame>3 years</time_frame>
    <description>Proportion of patients achieving a PSA decline ≥ 50% according to Prostate Cancer Working Group (PCWG2) criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate</measure>
    <time_frame>3 years</time_frame>
    <description>Percentage of participants with reduction in measurable disease on CT scan as defined by RECIST criteria: Complete Response (CR)= disappearance of all target lesions; Partial Response (PR)= at least a 30% decrease in the sum of the largest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD)= at least 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable disease (SD)= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to PSA progression</measure>
    <time_frame>3 years</time_frame>
    <description>Time to PSA progression as defined by PCWG2 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Clinical/radiographic progression</measure>
    <time_frame>3 years</time_frame>
    <description>Time to clinical/radiographic progression on CT and bone scan as defined by RECIST and PCWG2 criteria, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who experience acute graft-versus-host-disease (GVHD)</measure>
    <time_frame>3 years</time_frame>
    <description>Number of participants with acute GVHD grades 2-4 and grades 3-4 as defined by Przepiorka criteria. Przepiorka criteria stages the degree of organ involvement in the skin, liver and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least sever and Stage 4+ being most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, liver 4+)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who experience chronic GVHD</measure>
    <time_frame>3 years</time_frame>
    <description>Number of participants who experience chronic GVHD as defined by protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with donor chimerism</measure>
    <time_frame>up to 60 days</time_frame>
    <description>Patients with any amount of donor chimerism around day 60 will be considered as having engrafted. Chimerism determinations will be made on peripheral blood by a number of different methods depending on the specific patient. Methods may include (i) the usual standard of restriction fragment length polymorphism (RFLP) if the donor and recipient RFLPs are informative, (ii) fluorescence in-situ hybridization (FISH) for Y-chromosome markers on PBMC if the donor is male, (iii) cytogenetic analysis, (iv) flow cytometric analysis of HLA-A, B or DR on lymphocytes in the peripheral blood if haploidentical and suitable reagents exist or (v) PCR analysis of variable nucleotide tandem repeats (VNTR) in PBMC if informative. Mixed donor chimerism will be defined as &gt;0%, but &lt;95%. Complete donor chimerism will be defined as &gt;95%. Patients who have relapsed or died prior to day 60 will not be evaluable for full donor chimerism, as these are competing risk factors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with graft failure</measure>
    <time_frame>3 years</time_frame>
    <description>Number of participants with failure to engraft due to rejection by host lymphocytes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of post-transplantation cyclophosphamide on the immune reconstitution of T cells, B cells, and NK cells</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who develop HLA specific antibodies</measure>
    <time_frame>5 years</time_frame>
    <description>Number of participants who develop HLA specific antibodies after HLA mismatched, allogeneic partially HLA-mismatched bone marrow transplantation</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Bone marrow transplantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bone marrow transplantation followed by Cytoxan and testosterone&#xD;
Day -6 to -1: Subjects will be treated with a standard non-myeloablative conditioning regimen&#xD;
Day 0: subjects will be infused with non-T-cell depleted bone marrow from a related female donor.&#xD;
Subjects will receive GVHD prophylaxis consisting of:&#xD;
Day +3 and +4: Cytoxan (Cy) 50mg/kg IV Day +5 through Day +180: tacrolimus (IV or PO) beginning [dose adjusted to maintain trough level of 5-15 ng/mL] Day +5 through Day +35: Mycophenolate mofetil (MMF) 15 mg/kg PO TID, with a maximum dose of 1g TID.&#xD;
Day +5: filgrastim (G-CSF) 5 mcg/kg/day, continued until ANC ≥ 1500/mm3.&#xD;
Day +60, +90, and +120: testosterone cypionate 400 mg IM every 30 days x 3 doses&#xD;
Subjects will be maintained on continuous LHRH agonist/antagonist therapy (if not previously surgically castrated). Subjects who achieve biochemical CR will stop LHRH agonist/antagonist treatmentat day 180.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bone marrow transplantation</intervention_name>
    <description>Infused with non-T-cell depleted bone marrow from a related female donor on Day 0</description>
    <arm_group_label>Bone marrow transplantation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cytoxan</intervention_name>
    <description>Cytoxan 50mg/kg IV on Days +3 and +4</description>
    <arm_group_label>Bone marrow transplantation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>testosterone cypionate</intervention_name>
    <description>testosterone cypionate 400 mg IM will be administered on Day +60, +90, and +120 (every 30 days x 3 doses)</description>
    <arm_group_label>Bone marrow transplantation</arm_group_label>
    <other_name>testosterone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Performance status ≤1&#xD;
&#xD;
          -  Age ≥18 years and ≤ 75 years old&#xD;
&#xD;
          -  Histologically-confirmed adenocarcinoma of the prostate&#xD;
&#xD;
          -  Treated with continuous androgen ablative therapy (either surgical castration or LHRH&#xD;
             agonist/antagonist) with documented castrate level of serum testosterone (&lt;50 ng/dl)&#xD;
&#xD;
          -  Metastatic disease radiographically documented by CT or bone scan&#xD;
&#xD;
          -  Patient must be HLA typed at high resolution using DNA based typing at the following&#xD;
             loci: HLA-A, -B, -C, and DRB1&#xD;
&#xD;
          -  Patient must have available one or more potential first (biologic mother, sister,&#xD;
             half-sister, or daughter) or second-degree related female donor. Mothers and daughters&#xD;
             have a 100% chance of being haploidentical matches, sisters a 75% chance of being&#xD;
             matched or haploidentical, and second degree relatives have a 50% chance of being&#xD;
             haploidentical matches. The donor and recipient must be HLA identical for at least one&#xD;
             antigen at HLA-A, -B, -C and HLA-DRB1.&#xD;
&#xD;
          -  Screening PSA must be ≥ 1.0 ng/mL.&#xD;
&#xD;
          -  Prior therapy with one second line hormonal therapy is allowed (i.e. bicalutamide,&#xD;
             nilutamide, flutamide, ketoconazole, abiraterone, enzalutamide, ARN-509).&#xD;
&#xD;
          -  Prior docetaxel (≤ 6 cycles) as first line therapy&#xD;
&#xD;
          -  Cardiac ejection fraction at rest must be ≥ 40%&#xD;
&#xD;
          -  Acceptable liver function: Bilirubin &lt; 2.5 mg/dL (unless due to Gilbert's disease, AST&#xD;
             (SGOT) and ALT (SGPT) &lt; 5 times upper limit of normal.&#xD;
&#xD;
          -  Acceptable renal function: Serum creatinine within normal range.&#xD;
&#xD;
          -  Pulmonary function: DLCO (corrected for hemoglobin), FEV1 and FVC &gt;50% predicted.&#xD;
&#xD;
          -  At least 4 wks since prior radiation or surgery with full recovery (no persistent&#xD;
             toxicity ≥ Grade 1)&#xD;
&#xD;
          -  Ability to understand and willingness to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with Sipuleucel-T, radium-223, strontium-89, or samarium-153&#xD;
&#xD;
          -  Prior chemotherapy (docetaxel, cabazitaxel) for castrate resistant prostate cancer&#xD;
&#xD;
          -  Evidence of serious and/or unstable pre-existing medical, psychiatric or other&#xD;
             condition (including laboratory abnormalities) that could interfere with patient&#xD;
             safety or provision of informed consent to participate in this study&#xD;
&#xD;
          -  Active uncontrolled infection, including known history of HIV/AIDS or hepatitis B or&#xD;
             C.&#xD;
&#xD;
          -  Any psychological, familial, sociological, or geographical condition that could&#xD;
             potentially interfere with compliance with the study protocol and follow-up schedule.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samuel Denmeade, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>July 1, 2021</last_update_submitted>
  <last_update_submitted_qc>July 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Metastatic Castration-Resistant Prostate Cancer</keyword>
  <keyword>Bone Marrow Transplantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Methyltestosterone</mesh_term>
    <mesh_term>Testosterone</mesh_term>
    <mesh_term>Testosterone undecanoate</mesh_term>
    <mesh_term>Testosterone enanthate</mesh_term>
    <mesh_term>Testosterone 17 beta-cypionate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>July 7, 2022</submitted>
    <returned>May 12, 2023</returned>
    <submitted>May 23, 2023</submitted>
  </pending_results>
  <!-- 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/NCT02995330
org study id: J1608
secondary id: IRB00086105
nct id: NCT02995330
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Men with progressive metastatic Castration-Resistant Prostate Cancer post first-line
      treatment with either androgen deprivation therapy alone or androgen deprivation therapy plus
      docetaxel who have an identified related female donor (mother sister, daughter, second degree
      relative such as granddaughter or niece) will undergo bone marrow transplantation followed by
      post-transplant Cytoxan (PT/Cy) and testosterone.
Men will undergo pre-transplant screening evaluation and be enrolled in the study. Subjects
      will be treated with a standard non-myeloablative conditioning regimen consisting of
      Fludarabine 30 mg/m2 IV Days -6 to -2; Cy 14.5 mg/kg IV Days -6 and -5; Total body
      irradiation (TBI) 200 cGy Day -1. On Day 0, patients will be infused with non-T-cell depleted
      bone marrow from a related female donor. Patients will receive GVHD prophylaxis consisting
      of: Cy 50mg/kg IV on Days +3 and +4; tacrolimus (IV or PO) beginning on Day +5 [dose adjusted
      to maintain trough level of 5-15 ng/mL] through day+180; Mycophenolate mofetil (MMF) 15 mg/kg
      PO TID, with a maximum dose of 1g TID beginning on Day +5 through Day +35. Patients will
      receive filgrastim (G-CSF) 5 mcg/kg/day beginning on Day +5 and continued until ANC ≥
      1500/mm3. Lastly, to produce maintenance tumor antigen stimulation, patients will be
      maintained on continuous LHRH agonist/antagonist therapy (if not previously surgically
      castrated) to suppress endogenous testosterone production throughout the treatment period;
      testosterone cypionate 400 mg IM will be administered on Day +60, +90, and +120 (every 30
      days x 3 doses). Patients who achieve biochemical CR will stop LHRH agonist/antagonist
      treatment at day 180. Patients will be followed for 3 years post-BMT.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PSA response
time frame: 6 months
description: Percentage of participants with complete biochemical response at 6 months post-transplant (PSA <0.1 ng/mL for patients post-prostatectomy and PSA < 1 ng/mL for patients post-radiation therapy)
measure: Transplant-related mortality
time frame: 3 years
description: Number of participants who experience transplant-related mortality (TRM) following alloBMT
measure: PSA response rate
time frame: 3 years
description: Proportion of patients achieving a PSA decline ≥ 50% according to Prostate Cancer Working Group (PCWG2) criteria
measure: Objective response rate
time frame: 3 years
description: Percentage of participants with reduction in measurable disease on CT scan as defined by RECIST criteria: Complete Response (CR)= disappearance of all target lesions; Partial Response (PR)= at least a 30% decrease in the sum of the largest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD)= at least 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable disease (SD)= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
measure: Time to PSA progression
time frame: 3 years
description: Time to PSA progression as defined by PCWG2 criteria
measure: Time to Clinical/radiographic progression
time frame: 3 years
description: Time to clinical/radiographic progression on CT and bone scan as defined by RECIST and PCWG2 criteria, respectively.
measure: Number of participants who experience acute graft-versus-host-disease (GVHD)
time frame: 3 years
description: Number of participants with acute GVHD grades 2-4 and grades 3-4 as defined by Przepiorka criteria. Przepiorka criteria stages the degree of organ involvement in the skin, liver and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least sever and Stage 4+ being most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, liver 4+)
measure: Number of participants who experience chronic GVHD
time frame: 3 years
description: Number of participants who experience chronic GVHD as defined by protocol.
measure: Number of participants with donor chimerism
time frame: up to 60 days
description: Patients with any amount of donor chimerism around day 60 will be considered as having engrafted. Chimerism determinations will be made on peripheral blood by a number of different methods depending on the specific patient. Methods may include (i) the usual standard of restriction fragment length polymorphism (RFLP) if the donor and recipient RFLPs are informative, (ii) fluorescence in-situ hybridization (FISH) for Y-chromosome markers on PBMC if the donor is male, (iii) cytogenetic analysis, (iv) flow cytometric analysis of HLA-A, B or DR on lymphocytes in the peripheral blood if haploidentical and suitable reagents exist or (v) PCR analysis of variable nucleotide tandem repeats (VNTR) in PBMC if informative. Mixed donor chimerism will be defined as >0%, but <95%. Complete donor chimerism will be defined as >95%. Patients who have relapsed or died prior to day 60 will not be evaluable for full donor chimerism, as these are competing risk factors.
measure: Number of participants with graft failure
time frame: 3 years
description: Number of participants with failure to engraft due to rejection by host lymphocytes.
measure: Effects of post-transplantation cyclophosphamide on the immune reconstitution of T cells, B cells, and NK cells
time frame: 5 years
measure: Number of participants who develop HLA specific antibodies
time frame: 5 years
description: Number of participants who develop HLA specific antibodies after HLA mismatched, allogeneic partially HLA-mismatched bone marrow transplantation
arm group label: Bone marrow transplantation
arm group type: Experimental
description: Bone marrow transplantation followed by Cytoxan and testosterone
Day -6 to -1: Subjects will be treated with a standard non-myeloablative conditioning regimen
Day 0: subjects will be infused with non-T-cell depleted bone marrow from a related female donor.
Subjects will receive GVHD prophylaxis consisting of:
Day +3 and +4: Cytoxan (Cy) 50mg/kg IV Day +5 through Day +180: tacrolimus (IV or PO) beginning [dose adjusted to maintain trough level of 5-15 ng/mL] Day +5 through Day +35: Mycophenolate mofetil (MMF) 15 mg/kg PO TID, with a maximum dose of 1g TID.
Day +5: filgrastim (G-CSF) 5 mcg/kg/day, continued until ANC ≥ 1500/mm3.
Day +60, +90, and +120: testosterone cypionate 400 mg IM every 30 days x 3 doses
Subjects will be maintained on continuous LHRH agonist/antagonist therapy (if not previously surgically castrated). Subjects who achieve biochemical CR will stop LHRH agonist/antagonist treatmentat day 180.
intervention type: Procedure
intervention name: Bone marrow transplantation
description: Infused with non-T-cell depleted bone marrow from a related female donor on Day 0
arm group label: Bone marrow transplantation
intervention type: Drug
intervention name: Cytoxan
description: Cytoxan 50mg/kg IV on Days +3 and +4
arm group label: Bone marrow transplantation
intervention type: Drug
intervention name: testosterone cypionate
description: testosterone cypionate 400 mg IM will be administered on Day +60, +90, and +120 (every 30 days x 3 doses)
arm group label: Bone marrow transplantation
other name: testosterone
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Samuel Denmeade, MD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Cyclophosphamide
mesh term: Methyltestosterone
mesh term: Testosterone
mesh term: Testosterone undecanoate
mesh term: Testosterone enanthate
mesh term: Testosterone 17 beta-cypionate
sharing ipd: No
submitted: July 7, 2022
returned: May 12, 2023
submitted: May 23, 2023