<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/NCT04443062</url>
  </required_header>
  <id_info>
    <org_study_id>NL72585.091.20</org_study_id>
    <nct_id>NCT04443062</nct_id>
  </id_info>
  <brief_title>Lutetium-177-PSMA-617 in Oligo-metastatic Hormone Sensitive Prostate Cancer</brief_title>
  <acronym>Bullseye</acronym>
  <official_title>Lutetium-177-PSMA-617 Radioligand Therapy in Oligo-metastatic Hormone Sensitive Prostate Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Prostaatkankerstichting</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Advanced Accelerator Applications</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Radboud University Medical Center</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>
      Radioligand therapy (RLT) using Lutetium-177 labelled PSMA is a promising new therapeutic&#xD;
      approach to treat metastatic prostate cancer. This tumor-specific treatment is directed&#xD;
      against prostate-specific membrane antigen (PSMA), which is overexpressed in prostate cancer&#xD;
      cells. In the last few years, several lutetium-177 (177Lu, β emitter) labeled PSMA ligands&#xD;
      have been developed and are currently applied to treat metastatic castrate resistant prostate&#xD;
      cancer patients. To date, there are no prospective randomized studies published using this&#xD;
      treatment in the hormone sensitive setting or in oligometastatic prostate cancer. Therefore,&#xD;
      this study we will evaluate the effect of 177Lu-PSMA in patients with hormone sensitive&#xD;
      oligo-metastatic prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prostate-specific membrane antigen (PSMA) radioligand therapy (RLT) is a promising new&#xD;
      therapeutic approach to treat metastatic prostate cancer. This tumor-specific treatment is&#xD;
      directed against PSMA, which is overexpressed in prostate cancer cells. In the last few&#xD;
      years, several Lutetium-177 (177Lu, β emitter) labeled PSMA ligands have been developed and&#xD;
      are currently applied in nuclear medicine departments worldwide to treat metastatic castrate&#xD;
      resistant prostate cancer (mCRPC) patients.&#xD;
&#xD;
      A large retrospective study reported an overall biochemical response rate of 45% following&#xD;
      multiple 177Lu-PSMA RLT cycles in mCRPC patients, while 40% of patients already responded&#xD;
      after a single cycle. RLT with 177Lu-PSMA was generally well tolerated and 12% of the&#xD;
      patients suffered grade 3 to 4 hematological toxicity. In addition, mild and often transient&#xD;
      xerostomia occurred in 8%. A prospective study carried out in Australia confirmed these&#xD;
      results recently. Based on these outcomes Endocyte (a Novartis company) is currently carrying&#xD;
      out an international multicenter prospective registration study for end-stage mCRPC patients&#xD;
      (NCT03511664).&#xD;
&#xD;
      Although these results are promising, it is noteworthy that most of the currently available&#xD;
      data is retrospective and 177Lu-PSMA has only been evaluated in end stage prostate cancer&#xD;
      patients to date. However, based on the mode of action, 177Lu-PSMA could also be effective in&#xD;
      low volume disease because of the very high tumor uptake of radioligands in smaller lesions.&#xD;
      Also, in a pilot study (NCT03828838) we were able to show that 177Lu-PSMA treatment is safe&#xD;
      coupled with promising response rates. Hence, the present randomized trial to investigate the&#xD;
      efficacy of 177Lu-PSMA in patients with oligo-metastatic (≤5 metastases) metastatic prostate&#xD;
      cancer, prior to the hormone insensitive state. In this study, 58 patients will be included&#xD;
      in a 1:1 ratio to receive either 177Lu-PSMA or the current standard of care (deferred&#xD;
      androgen deprivation therapy).&#xD;
&#xD;
      At the end of the study period for answering the primary research question, patients&#xD;
      randomized to the control arm are eligible to receive 177Lu-PSMA if they meet the end of the&#xD;
      study period treatment (EOT 1) criteria and are willing to undergo 177Lu-PSMA.&#xD;
&#xD;
      EOT 1 is defined by:&#xD;
&#xD;
        -  Clinical progression determined by the treating physician (e.g. increasing pain from&#xD;
           metastases)&#xD;
&#xD;
        -  A 100% increase in PSA after cycle one blood draw (BASELINE) during study. Exception:&#xD;
           PSA increase in the first 12 weeks after the first treatment injection as was defined by&#xD;
           the PCWG3 criteria.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Anticipated">January 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2024</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>
    <intervention_model_description>Randomized, two-arm, open label, multi-center, phase II study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To compare the fraction of patients that have disease progression (and meet EOT 1) criteria within 6 months in a group of patients that are treated with 177Lu-PSMA and a group that follows the current standard of care.</measure>
    <time_frame>30 weeks</time_frame>
    <description>Disease progression (EOT 1) is defined by:&#xD;
A 100% increase in PSA after cycle one blood draw (BASELINE) during study. Exception: PSA increase in the first 12 weeks after the first treatment injection as was defined by the PCWG3 criteria. Or;&#xD;
Clinical progression determined by the treating physician (e.g. increasing pain from metastases).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>A second primary aim is to compare the two arms for the time to disease progression and meeting EOT 1 criteria.</measure>
    <time_frame>30 weeks</time_frame>
    <description>Disease progression (EOT 1) is defined by:&#xD;
A 100% increase in PSA after cycle one blood draw (BASELINE) during study. Exception: PSA increase in the first 12 weeks after the first treatment injection as was defined by the PCWG3 criteria. Or;&#xD;
Clinical progression determined by the treating physician (e.g. increasing pain from metastases).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the clinical efficacy of multiple doses 177Lu-PSMA radioligand therapy in patients with oligo-metastatic, hormone sensitive metastatic PCa by:</measure>
    <time_frame>30 weeks</time_frame>
    <description>The change in PSA after 177Lu-PSMA and proportion of achieving a ≥ 50% decrease in PSA from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the clinical efficacy of multiple doses 177Lu-PSMA radioligand therapy in patients with oligo-metastatic, hormone sensitive metastatic PCa by:</measure>
    <time_frame>30 weeks</time_frame>
    <description>The changes in uptake (SUVmax) of 18F-PSMA PET/CT before and 6 months after 177Lu-PSMA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the clinical efficacy of multiple doses 177Lu-PSMA radioligand therapy in patients with oligo-metastatic, hormone sensitive metastatic PCa by:</measure>
    <time_frame>30 weeks</time_frame>
    <description>The size of soft tissue metastases on 18F-PSMA PET/CT and (whole body) MRI after 177Lu-PSMA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival defined as from the time from inclusion to date of evidence of clinical progression, death from any cause, PSA progression, or radiographic progression.</measure>
    <time_frame>30 weeks</time_frame>
    <description>Clinical progression is defined by the treating physician (e.g. increasing pain from metastases). PSA progression is defined as a ≥ 25% increase in PSA from nadir, with a minimum PSA of &gt;0,5 µg/l and which is confirmed by a second value ≥ 3 weeks later (i.e. confirmed rising trend). Within the first 12 weeks after treatment administration PSA increases will be ignored in the absence of other evidence of disease progression due to the flare phenomenon. If no decline occurs, date of ≥ 25% increase will be recorded. Radiographic progression is defined by the amount and size of the lesions. Where applicable PCWG3 and RECIST v1.1 criteria will be followed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time till initiation of ADT in patients receiving 177Lu-PSMA. ADT free survival is defined by the date any ADT (e.g. bicalutamide, LHRH, enzalutamide, abiraterone, etc.) is started or death related to PCa.</measure>
    <time_frame>30 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the tolerability and toxicity of 177Lu-PSMA defined by NCI Common Terminology Criteria for Adverse Events v5.0.</measure>
    <time_frame>30 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the quality of life before and up to 6 months after 177Lu-PSMA RLT.</measure>
    <time_frame>30 weeks</time_frame>
    <description>The following questionnaires will be used: EORTC QLQ-C30, QLQ-PR25 &amp; xerostomia inventory.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">58</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Interventional arm: 177Lu-PSMA radioligand therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 (+2) cycles of 7.4 GBq 177Lu-PSMA 6 weeks in between</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Deferred androgen deprivation therapy. However, the control arm can receive the study drug (177Lu-PSMA) in case of disease progression (defined in the study protocol).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>177Lu-PSMA-617</intervention_name>
    <description>PSMA radioligand therapy</description>
    <arm_group_label>Interventional arm: 177Lu-PSMA radioligand therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological proven adenocarcinoma of the prostate with sufficient archived tumor&#xD;
             material. This material has to be archived till study closure.&#xD;
&#xD;
          -  Biochemical recurrence (PSA &gt; 1.0 µg/l).&#xD;
&#xD;
          -  PSA-doubling time &lt; 6 months. Serum PSA progression is defined as 2 consecutive rising&#xD;
             PSA values measured at least 1 week apart. The minimal start value is 0.2 µg/l.&#xD;
&#xD;
          -  18F-PSMA-PET-CT positive metastases in bones and/or lymph nodes (N1/M1ab): ≥1,&#xD;
             maximally 5 metastases.&#xD;
&#xD;
          -  Local treatment for oligo-metastases with radiotherapy or surgery appears to be no&#xD;
             option anymore (due to prior treatment or the location of the metastatic lesions or if&#xD;
             the patient refuse these treatments).&#xD;
&#xD;
          -  No prior hormonal therapy (including any androgen directed treatment such as&#xD;
             finasteride, dutasteride, bicalutamide, apalutamide, abiraterone or enzalutamide) or&#xD;
             taxane based chemotherapy (docetaxel or cabazitaxel); testosterone &gt; 1.7 nmol/l.&#xD;
&#xD;
        Exception: local prostate cancer treated with local radiotherapy plus adjuvant ADT; these&#xD;
        patients need to be stopped with ADT at least 6 months.&#xD;
&#xD;
          -  A detectable lesion on the 18F-PSMA PET/CT with significant PSMA avidity, defined by a&#xD;
             SUVmax &gt; 15 (partial volume corrected).&#xD;
&#xD;
          -  ECOG 0-1&#xD;
&#xD;
          -  Patients must have a life expectancy &gt;6 months.&#xD;
&#xD;
          -  Laboratory values:&#xD;
&#xD;
               -  White blood cells &gt; 3.0 x 109/l&#xD;
&#xD;
               -  Platelet count &gt; 75 x 109/l&#xD;
&#xD;
               -  Hemoglobin &gt; 6.2 mmol/l&#xD;
&#xD;
               -  ASAT, ALAT &lt; 3 x ULN&#xD;
&#xD;
               -  MDRD-GFR ≥ 50 ml/min&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A known subtype other than prostate adenocarcinoma.&#xD;
&#xD;
          -  Previous PSMA based radioligand treatment.&#xD;
&#xD;
          -  Visceral or brain metastases.&#xD;
&#xD;
          -  Any medical condition present that in the opinion of the investigator will affect&#xD;
             patients' clinical status when participating in this trial.&#xD;
&#xD;
          -  Prior hip replacement surgery potentially influencing performance of PSMA PET/CT.&#xD;
&#xD;
          -  Sjogren's syndrome&#xD;
&#xD;
          -  A second active malignancy other than prostate cancer.&#xD;
&#xD;
          -  Patients who are sexually active and not willing/able to use medically acceptable&#xD;
             forms of barrier contraception.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Nagarajah, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboud University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bastiaan Privé, MD</last_name>
    <phone>+31 (0)24 3090031</phone>
    <email>bastiaan.prive@radboudumc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Berrevoets &amp; De Groot</last_name>
    <phone>+31 (0)24 366 72 43</phone>
    <email>studiedeelnemersNG.radng@radboudumc.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>German Oncology Center</name>
      <address>
        <city>Limassol</city>
        <country>Cyprus</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Alexis Vrachimis, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Amsterdam UMC</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Daniela Oprea-Lager, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Walter Noordzij, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Radboud University</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>James Nagarajah, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bastiaan Privé, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Cyprus</country>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>Rahbar K, Ahmadzadehfar H, Kratochwil C, Haberkorn U, Schafers M, Essler M, Baum RP, Kulkarni HR, Schmidt M, Drzezga A, Bartenstein P, Pfestroff A, Luster M, Lutzen U, Marx M, Prasad V, Brenner W, Heinzel A, Mottaghy FM, Ruf J, Meyer PT, Heuschkel M, Eveslage M, Bogemann M, Fendler WP, Krause BJ. German Multicenter Study Investigating 177Lu-PSMA-617 Radioligand Therapy in Advanced Prostate Cancer Patients. J Nucl Med. 2017 Jan;58(1):85-90. doi: 10.2967/jnumed.116.183194. Epub 2016 Oct 20.</citation>
    <PMID>27765862</PMID>
  </reference>
  <reference>
    <citation>Hofman MS, Violet J, Hicks RJ, Ferdinandus J, Thang SP, Akhurst T, Iravani A, Kong G, Ravi Kumar A, Murphy DG, Eu P, Jackson P, Scalzo M, Williams SG, Sandhu S. [177Lu]-PSMA-617 radionuclide treatment in patients with metastatic castration-resistant prostate cancer (LuPSMA trial): a single-centre, single-arm, phase 2 study. Lancet Oncol. 2018 Jun;19(6):825-833. doi: 10.1016/S1470-2045(18)30198-0. Epub 2018 May 8.</citation>
    <PMID>29752180</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>April 17, 2023</last_update_submitted>
  <last_update_submitted_qc>April 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate cancer</keyword>
  <keyword>Hormone sensitive</keyword>
  <keyword>Oligometastases</keyword>
  <keyword>177Lu-PSMA</keyword>
  <keyword>Metastases directed therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>177Lu-PSMA-617</mesh_term>
  </intervention_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/NCT04443062
org study id: NL72585.091.20
nct id: NCT04443062
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Radioligand therapy (RLT) using Lutetium-177 labelled PSMA is a promising new therapeutic
      approach to treat metastatic prostate cancer. This tumor-specific treatment is directed
      against prostate-specific membrane antigen (PSMA), which is overexpressed in prostate cancer
      cells. In the last few years, several lutetium-177 (177Lu, β emitter) labeled PSMA ligands
      have been developed and are currently applied to treat metastatic castrate resistant prostate
      cancer patients. To date, there are no prospective randomized studies published using this
      treatment in the hormone sensitive setting or in oligometastatic prostate cancer. Therefore,
      this study we will evaluate the effect of 177Lu-PSMA in patients with hormone sensitive
      oligo-metastatic prostate cancer.
Prostate-specific membrane antigen (PSMA) radioligand therapy (RLT) is a promising new
      therapeutic approach to treat metastatic prostate cancer. This tumor-specific treatment is
      directed against PSMA, which is overexpressed in prostate cancer cells. In the last few
      years, several Lutetium-177 (177Lu, β emitter) labeled PSMA ligands have been developed and
      are currently applied in nuclear medicine departments worldwide to treat metastatic castrate
      resistant prostate cancer (mCRPC) patients.

      A large retrospective study reported an overall biochemical response rate of 45% following
      multiple 177Lu-PSMA RLT cycles in mCRPC patients, while 40% of patients already responded
      after a single cycle. RLT with 177Lu-PSMA was generally well tolerated and 12% of the
      patients suffered grade 3 to 4 hematological toxicity. In addition, mild and often transient
      xerostomia occurred in 8%. A prospective study carried out in Australia confirmed these
      results recently. Based on these outcomes Endocyte (a Novartis company) is currently carrying
      out an international multicenter prospective registration study for end-stage mCRPC patients
      (NCT03511664).

      Although these results are promising, it is noteworthy that most of the currently available
      data is retrospective and 177Lu-PSMA has only been evaluated in end stage prostate cancer
      patients to date. However, based on the mode of action, 177Lu-PSMA could also be effective in
      low volume disease because of the very high tumor uptake of radioligands in smaller lesions.
      Also, in a pilot study (NCT03828838) we were able to show that 177Lu-PSMA treatment is safe
      coupled with promising response rates. Hence, the present randomized trial to investigate the
      efficacy of 177Lu-PSMA in patients with oligo-metastatic (≤5 metastases) metastatic prostate
      cancer, prior to the hormone insensitive state. In this study, 58 patients will be included
      in a 1:1 ratio to receive either 177Lu-PSMA or the current standard of care (deferred
      androgen deprivation therapy).

      At the end of the study period for answering the primary research question, patients
      randomized to the control arm are eligible to receive 177Lu-PSMA if they meet the end of the
      study period treatment (EOT 1) criteria and are willing to undergo 177Lu-PSMA.

      EOT 1 is defined by:

        -  Clinical progression determined by the treating physician (e.g. increasing pain from
           metastases)

        -  A 100% increase in PSA after cycle one blood draw (BASELINE) during study. Exception:
           PSA increase in the first 12 weeks after the first treatment injection as was defined by
           the PCWG3 criteria.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, two-arm, open label, multi-center, phase II study
primary purpose: Treatment
masking: None (Open Label)
measure: To compare the fraction of patients that have disease progression (and meet EOT 1) criteria within 6 months in a group of patients that are treated with 177Lu-PSMA and a group that follows the current standard of care.
time frame: 30 weeks
description: Disease progression (EOT 1) is defined by:
A 100% increase in PSA after cycle one blood draw (BASELINE) during study. Exception: PSA increase in the first 12 weeks after the first treatment injection as was defined by the PCWG3 criteria. Or;
Clinical progression determined by the treating physician (e.g. increasing pain from metastases).
measure: A second primary aim is to compare the two arms for the time to disease progression and meeting EOT 1 criteria.
time frame: 30 weeks
description: Disease progression (EOT 1) is defined by:
A 100% increase in PSA after cycle one blood draw (BASELINE) during study. Exception: PSA increase in the first 12 weeks after the first treatment injection as was defined by the PCWG3 criteria. Or;
Clinical progression determined by the treating physician (e.g. increasing pain from metastases).
measure: To evaluate the clinical efficacy of multiple doses 177Lu-PSMA radioligand therapy in patients with oligo-metastatic, hormone sensitive metastatic PCa by:
time frame: 30 weeks
description: The change in PSA after 177Lu-PSMA and proportion of achieving a ≥ 50% decrease in PSA from baseline.
measure: To evaluate the clinical efficacy of multiple doses 177Lu-PSMA radioligand therapy in patients with oligo-metastatic, hormone sensitive metastatic PCa by:
time frame: 30 weeks
description: The changes in uptake (SUVmax) of 18F-PSMA PET/CT before and 6 months after 177Lu-PSMA.
measure: To evaluate the clinical efficacy of multiple doses 177Lu-PSMA radioligand therapy in patients with oligo-metastatic, hormone sensitive metastatic PCa by:
time frame: 30 weeks
description: The size of soft tissue metastases on 18F-PSMA PET/CT and (whole body) MRI after 177Lu-PSMA.
measure: Progression free survival defined as from the time from inclusion to date of evidence of clinical progression, death from any cause, PSA progression, or radiographic progression.
time frame: 30 weeks
description: Clinical progression is defined by the treating physician (e.g. increasing pain from metastases). PSA progression is defined as a ≥ 25% increase in PSA from nadir, with a minimum PSA of >0,5 µg/l and which is confirmed by a second value ≥ 3 weeks later (i.e. confirmed rising trend). Within the first 12 weeks after treatment administration PSA increases will be ignored in the absence of other evidence of disease progression due to the flare phenomenon. If no decline occurs, date of ≥ 25% increase will be recorded. Radiographic progression is defined by the amount and size of the lesions. Where applicable PCWG3 and RECIST v1.1 criteria will be followed.
measure: Time till initiation of ADT in patients receiving 177Lu-PSMA. ADT free survival is defined by the date any ADT (e.g. bicalutamide, LHRH, enzalutamide, abiraterone, etc.) is started or death related to PCa.
time frame: 30 weeks
measure: To evaluate the tolerability and toxicity of 177Lu-PSMA defined by NCI Common Terminology Criteria for Adverse Events v5.0.
time frame: 30 weeks
measure: To evaluate the quality of life before and up to 6 months after 177Lu-PSMA RLT.
time frame: 30 weeks
description: The following questionnaires will be used: EORTC QLQ-C30, QLQ-PR25 & xerostomia inventory.
arm group label: Interventional arm: 177Lu-PSMA radioligand therapy
arm group type: Experimental
description: 2 (+2) cycles of 7.4 GBq 177Lu-PSMA 6 weeks in between
arm group label: Standard of care
arm group type: No Intervention
description: Deferred androgen deprivation therapy. However, the control arm can receive the study drug (177Lu-PSMA) in case of disease progression (defined in the study protocol).
intervention type: Drug
intervention name: 177Lu-PSMA-617
description: PSMA radioligand therapy
arm group label: Interventional arm: 177Lu-PSMA radioligand therapy
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: James Nagarajah, Prof.
role: Principal Investigator
affiliation: Radboud University Medical Center
last name: Bastiaan Privé, MD
phone: +31 (0)24 3090031
email: bastiaan.prive@radboudumc.nl
last name: Berrevoets & De Groot
phone: +31 (0)24 366 72 43
email: studiedeelnemersNG.radng@radboudumc.nl
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
investigator: 
country: Cyprus
country: Netherlands
citation: Rahbar K, Ahmadzadehfar H, Kratochwil C, Haberkorn U, Schafers M, Essler M, Baum RP, Kulkarni HR, Schmidt M, Drzezga A, Bartenstein P, Pfestroff A, Luster M, Lutzen U, Marx M, Prasad V, Brenner W, Heinzel A, Mottaghy FM, Ruf J, Meyer PT, Heuschkel M, Eveslage M, Bogemann M, Fendler WP, Krause BJ. German Multicenter Study Investigating 177Lu-PSMA-617 Radioligand Therapy in Advanced Prostate Cancer Patients. J Nucl Med. 2017 Jan;58(1):85-90. doi: 10.2967/jnumed.116.183194. Epub 2016 Oct 20.
PMID: 27765862
citation: Hofman MS, Violet J, Hicks RJ, Ferdinandus J, Thang SP, Akhurst T, Iravani A, Kong G, Ravi Kumar A, Murphy DG, Eu P, Jackson P, Scalzo M, Williams SG, Sandhu S. [177Lu]-PSMA-617 radionuclide treatment in patients with metastatic castration-resistant prostate cancer (LuPSMA trial): a single-centre, single-arm, phase 2 study. Lancet Oncol. 2018 Jun;19(6):825-833. doi: 10.1016/S1470-2045(18)30198-0. Epub 2018 May 8.
PMID: 29752180
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Hypersensitivity
mesh term: 177Lu-PSMA-617
sharing ipd: Undecided