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Prostate Cancer MetastaticNCT04833517

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

An observational study of Prostate Cancer Metastatic and Castration Resistant Prostatic Cancer, run by Universität des Saarlandes at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
How many people
500 participants
Where
1 siteGermany
Study dates
1 Jan 2016to 31 Dec 2025
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with advanced castration-resistant prostate cancer, who receive radionuclide treatment including PSMA-targeted radioligand therapy, Radium-223 or other bone-targeted radionuclide therapy and liver-directed radioembolization.

Who may be able to join

  • Signed informed consent form (Registry Study Inclusion Form)
  • sufficient tumoral PSMA expression defined as tracer uptake markedly higher than (physiologic) uptake in healthy liver tissue.
  • sufficient bone marrow reserve: leukocytes ≥ 2 G/L, platelets > 75 × 109/L
  • sufficient overall patient condition: Eastern Oncology Cooperative Group (ECOG) performance status ≤ 3

Who cannot join

  • Inability or unwillingness to provide informed consent

Trial locations and contacts

1 site in 1 country.

Samer Ezziddin, MSc, MD, PhD contact

+49 6841 16 22201

PSMA@uks.eu

Katja Threm contact

+49 6841 16 24667

nuklearmedizin@uks.eu

Germany1 site, 1 recruiting

  • Dept. of Nuclear Medicine, Saarland University

    Homburg, Saarland, 66421

    Recruiting

Other trials in Germany

About this study

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.

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.

Read the 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 site of metastases with PSMA-expression (ß- / alpha-emitter 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.

Keywords
mCRPC, Radioligand Therapy, PSMA, PSMA-targeted Therapy, Radionuclide Therapy, Ra-223, Bone-targeted Radionuclide Therapy, Radioembolization, SIRT
Medical subject headings
Prostatic Neoplasms, Castration-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04833517
Study groupRoleWhat they receive
Lu177 PSMA RLTLutetium-177 prostate-specific membrane antigen (Lu177 PSMA) radioligand therapy (RLT) according to standard local protocol
Ac225 PSMA RLTActinium-225 prostate-specific membrane antigen (Ac225 PSMA) radioligand therapy (RLT) according to standard local protocol
Tandem Lu177 / Ac225 PSMA RLTCombined Lu177 / Ac225 PSMA radioligand therapy according to standard local protocol
Ra223 chlorideBone-targeted Radium-223 (Ra223) radionuclide therapy in standard application
Sm153 EDTMPBone-targeted Samarium-153 (Sm153) EDTMP radionuclide therapy in standard application
Y90 microspheresRadioembolization with yttrium-90 (Y90) microspheres, standard methodology
Tb161 PSMA RLTTerbium-161 prostate-specific membrane antigen (Tb161 PSMA) radioligand therapy (RLT) according to standard local protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PSA response

    Best PSA response and PSA response after 3 months from start of radionuclide therapy

    Measured: up to 10 years

  2. PSA-PFS

    PSA-based progression-free survival (PFS) according to PCWG3 criteria. From date of start of radionuclide therapy until documented and confirmed PSA-progression

    Measured: up to 10 years

  3. OS

    Overall survival. From date of start of radionuclide therapy until the date of death from any cause assessed

    Measured: up to 10 years

  4. Toxicity (adverse events)

    All toxicity occurring after start of radionuclide treatment will be registered according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.03).

    Measured: up to 10 years

  5. Toxicity-related discontinuation of radionuclide treatment

    Rate of toxicity-related discontinuation of radionuclide therapy

    Measured: up to 10 years

Secondary outcomes (5)

  1. Conventional imaging response

    Response to radionuclide therapy based on conventional imaging according to RECIST 1.1

    Measured: up to10 years

  2. Molecular imaging response

    Response to radionuclide therapy based on molecular imaging

    Measured: up to 10 years

  3. Quality-of-life in patients receiving radionuclide therapy

    Quality-of-life assessed from start of radionuclide treatment by EORTC QLQ-C30 questionaires

    Measured: up to 10 years

  4. Pain control achieved by radionuclide therapy

    Based on VAS-BPI patient questionaires from start of radionuclide treatment

    Measured: up to 10 years

  5. Absorbed doses achieved by radionuclide therapy

    Absorbed doses in Gy/GBq based on intra- / posttherapeutic dosimetry when available

    Measured: up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2021
  2. Study start1 Jan 2016
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04833517
Sponsor's protocol ID
RNT-Prostate
Status last verified
Dec 2022
First submitted
31 Mar 2021
Last updated
8 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bastian MB, Speicher T, Blickle A, Burgard C, Bastian JLD, Bartholoma M, Schaefer-Schuler A, Maus S, Ezziddin S, Rosar F. Tolerability of PSMA radioligand therapy in metastatic prostate cancer patients with baseline mild to moderate leukopenia. EJNMMI Res. 2025 Jul 6;15(1):82. doi: 10.1186/s13550-025-01280-0.

    PubMed 40619537

  • Rosar F, Schuler J, Burgard C, Blickle A, Bartholoma M, Maus S, Petto S, Khreish F, Schaefer A, Ezziddin S. Efficacy and safety of rechallenge [177Lu]Lu-PSMA-617 RLT after initial partial remission in patients with mCRPC: evaluation of a prospective registry (REALITY study). Eur J Nucl Med Mol Imaging. 2024 Nov;51(13):4151-4162. doi: 10.1007/s00259-024-06825-4. Epub 2024 Jul 15.

    PubMed 39008067

  • Rosar F, Burgard C, Rohloff LV, Blickle A, Bartholoma M, Maus S, Petto S, Schaefer-Schuler A, Ezziddin S. 225 Ac-PSMA-617 Augmentation in High-Risk mCRPC Undergoing 177 Lu-PSMA-617 Radioligand Therapy : Pilot Experience From a Prospective Registry. Clin Nucl Med. 2024 Jul 1;49(7):621-629. doi: 10.1097/RLU.0000000000005253. Epub 2024 May 21.

    PubMed 38769643

  • Burgard C, Hein C, Blickle A, Bartholoma M, Maus S, Petto S, Schaefer-Schuler A, Ezziddin S, Rosar F. Change in total lesion PSMA (TLP) during [177Lu]Lu-PSMA-617 radioligand therapy predicts overall survival in patients with mCRPC: monocentric evaluation of a prospective registry. Eur J Nucl Med Mol Imaging. 2024 Feb;51(3):885-895. doi: 10.1007/s00259-023-06476-x. Epub 2023 Oct 27.

    PubMed 37889298

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer Metastatic and Castration Resistant Prostatic Cancer, run by Universität des Saarlandes at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Samer Ezziddin, MSc, MD, PhD (+49 6841 16 22201, PSMA@uks.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PSA response (time frame: up to 10 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04833517, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.

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