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Prospective REgistry of Targeted RadionucLide TherapY in Patients With mCRPC (REALITY Study)

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ClinicalTrials.gov Identifier: NCT04833517
Recruitment Status : Recruiting
First Posted : April 6, 2021
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Samer Ezziddin, MD, Universität des Saarlandes

Brief Summary:
This prospective registry aims to assess outcome and toxicity of targeted radionuclide therapies in patients with advanced prostate cancer in clinical routine. While the major investigated treatment modality is prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, also other radionuclide therapies such as Ra223 and liver-directed radioembolization are included. The investigators believe that prospectively assessed long-term outcome data on implementation of radionuclide therapy, especially in the palliative setting of advanced mCRPC, help to better define the real benefits and risks of the respective treatment modalities for patients regarding survival and quality-of-life.

Condition or disease
Prostate Cancer Metastatic Castration Resistant Prostatic Cancer Advanced Prostate Carcinoma

Detailed Description:

Targeted radionuclide therapy is comprised of different modalities that may be applied in advanced prostate cancer, either targeting bone metastases (mainly using Radium-223), any type of metastases with PSMA-expression (Lutetium-177 and Actinium-225 labelled radioligands) or loco-regionally applying internal radiation (Yttrium-90 microspheres) to metastatic liver disease. While in Germany, each form of treatment is used in clinical routine, data is sparse regarding the real benefits and risks of respective modalities, also when used in a sequential order. As an example, patients receiving Ra223 treatment may later undergo PSMA targeted radioligand therapy, with little data available on dependent response relationships or cumulative risks. Prospective assessment of outcomes and toxicities in a radionuclide therapy registry is apparently superior over retrospective analyses of selected patient populations.

The goal of the REALITY study is to gain a better understanding of the real-life clinical application of radionuclide therapies, with a focus on PSMA-targeted radioligand therapy in a high-volume treatment centre, and the impact of each treatment for patient outcome.

Based on primary and secondary outcome measures the potential prediction of treatment benefit by baseline patient and tumor characteristics, and early changes of biomarkers will be of interest.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: REALITY Study: Analysis of a Prospective REgistry to Assess Outcome and Toxicity of Targeted RadionucLide TherapY in Patients With mCRPC in Clinical Routine.
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Group/Cohort
Lu177 PSMA RLT
Lutetium-177 prostate-specific membrane antigen (Lu177 PSMA) radioligand therapy (RLT) according to standard local protocol
Ac225 PSMA RLT
Actinium-225 prostate-specific membrane antigen (Ac225 PSMA) radioligand therapy (RLT) according to standard local protocol
Tandem Lu177 / Ac225 PSMA RLT
Combined Lu177 / Ac225 PSMA radioligand therapy according to standard local protocol
Ra223 chloride
Bone-targeted Radium-223 (Ra223) radionuclide therapy in standard application
Sm153 EDTMP
Bone-targeted Samarium-153 (Sm153) EDTMP radionuclide therapy in standard application
Y90 microshperes
Radioembolization with yttrium-90 (Y90) microspheres, standard methodology



Primary Outcome Measures :
  1. PSA response [ Time Frame: up to 10 years ]
    Best PSA response and PSA response after 3 months from start of radionuclide therapy

  2. PSA-PFS [ Time Frame: up to 10 years ]
    PSA-based progression-free survival (PFS) according to PCWG3 criteria. From date of start of radionuclide therapy until documented and confirmed PSA-progression

  3. OS [ Time Frame: up to 10 years ]
    Overall survival. From date of start of radionuclide therapy until the date of death from any cause assessed

  4. Toxicity (adverse events) [ Time Frame: up to 10 years ]
    All toxicity occurring after start of radionuclide treatment will be registered according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.03).

  5. Toxicity-related discontinuation of radionuclide treatment [ Time Frame: up to 10 years ]
    Rate of toxicity-related discontinuation of radionuclide therapy


Secondary Outcome Measures :
  1. Conventional imaging response [ Time Frame: up to10 years ]
    Response to radionuclide therapy based on conventional imaging according to RECIST 1.1

  2. Molecular imaging response [ Time Frame: up to 10 years ]
    Response to radionuclide therapy based on molecular imaging

  3. Quality-of-life in patients receiving radionuclide therapy [ Time Frame: up to 10 years ]
    Quality-of-life assessed from start of radionuclide treatment by EORTC QLQ-C30 questionaires

  4. Pain control achieved by radionuclide therapy [ Time Frame: up to 10 years ]
    Based on VAS-BPI patient questionaires from start of radionuclide treatment

  5. Absorbed doses achieved by radionuclide therapy [ Time Frame: up to 10 years ]
    Absorbed doses in Gy/GBq based on intra- / posttherapeutic dosimetry when available



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with advanced castration-resistant prostate cancer, who receive radionuclide treatment including Lutetium-177 PSMA-targeted radioligand therapy, Actinium-225 PSMA-targeted radioligand therapy, Radium-223 or other bone-targeted radionuclide therapy and liver-directed radioembolization.
Criteria

Inclusion Criteria:

  • Signed informed consent form (Registry Study Inclusion Form)

Exclusion Criteria:

  • Inability or unwillingness to provide informed consent

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): NCT04833517


Contacts
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Contact: Samer Ezziddin, MSc, MD, PhD +49 6841 16 22201 PSMA@uks.eu
Contact: Katja Threm +49 6841 16 24667 nuklearmedizin@uks.eu

Locations
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Germany
Dept. of Nuclear Medicine, Saarland University Recruiting
Homburg, Saarland, Germany, 66421
Sponsors and Collaborators
Universität des Saarlandes
Investigators
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Principal Investigator: Samer Ezziddin, MSc, MD, PhD Universität des Saarlandes
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Responsible Party: Samer Ezziddin, MD, Director, Dept. of Nuclear Medicine, Universität des Saarlandes
ClinicalTrials.gov Identifier: NCT04833517    
Other Study ID Numbers: RNT-Prostate
First Posted: April 6, 2021    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samer Ezziddin, MD, Universität des Saarlandes:
mCRPC
Radioligand Therapy
PSMA
PSMA-targeted Therapy
Radionuclide Therapy
Ra-223
Bone-targeted Radionuclide Therapy
Radioembolization
SIRT
Additional relevant MeSH terms:
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Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases