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.
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
- Conditions the study is for
- Prostate Cancer Metastatic, Castration Resistant Prostatic Cancer, Advanced Prostate Carcinoma
- 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.
Germany1 site, 1 recruiting
- Recruiting
Dept. of Nuclear Medicine, Saarland University
Homburg, Saarland, 66421
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.
- Conditions
- Prostate Cancer Metastatic, Castration Resistant Prostatic Cancer, Advanced Prostate Carcinoma
- 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 group | Role | What they receive |
|---|---|---|
| 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 microspheres | Radioembolization with yttrium-90 (Y90) microspheres, standard methodology | |
| Tb161 PSMA RLT | Terbium-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.
PSA response
Best PSA response and PSA response after 3 months from start of radionuclide therapy
Measured: up to 10 years
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
OS
Overall survival. From date of start of radionuclide therapy until the date of death from any cause assessed
Measured: up to 10 years
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
Toxicity-related discontinuation of radionuclide treatment
Rate of toxicity-related discontinuation of radionuclide therapy
Measured: up to 10 years
Secondary outcomes (5)
Conventional imaging response
Response to radionuclide therapy based on conventional imaging according to RECIST 1.1
Measured: up to10 years
Molecular imaging response
Response to radionuclide therapy based on molecular imaging
Measured: up to 10 years
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
Pain control achieved by radionuclide therapy
Based on VAS-BPI patient questionaires from start of radionuclide treatment
Measured: up to 10 years
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.
- First posted6 Apr 2021
- Study start1 Jan 2016
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samer Ezziddin, MD, Universität des Saarlandes
- Investigators
- Samer Ezziddin, MSc, MD, PhD, Principal investigator, Universität des Saarlandes
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 40619537Rosar 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 39008067Rosar 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 38769643Burgard 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04833517
- Acronym / sponsor ID
- RNT-Prostate
- Conditions
- Prostate Cancer Metastatic, Castration Resistant Prostatic Cancer, Advanced Prostate Carcinoma
- Keywords
- mCRPC, Radioligand Therapy, PSMA, PSMA-targeted Therapy, Radionuclide Therapy, Ra-223, Bone-targeted Radionuclide Therapy, Radioembolization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 microspheres | – | –Radioembolization with yttrium-90 (Y90) microspheres, standard methodology |
| Tb161 PSMA RLT | – | –Terbium-161 prostate-specific membrane antigen (Tb161 PSMA) radioligand therapy (RLT) according to standard local protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Inability or unwillingness to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PSA response
Time frame: up to 10 years
Best PSA response and PSA response after 3 months from start of radionuclide therapy
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
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
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).
Toxicity-related discontinuation of radionuclide treatment
Time frame: up to 10 years
Rate of toxicity-related discontinuation of radionuclide therapy
5 secondary outcomes
Conventional imaging response
Time frame: up to10 years
Molecular imaging response
Time frame: up to 10 years
Quality-of-life in patients receiving radionuclide therapy
Time frame: up to 10 years
Pain control achieved by radionuclide therapy
Time frame: up to 10 years
Absorbed doses achieved by radionuclide therapy
Time frame: up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Derived from this study: PubMed 40619537Bastian 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.
- Derived from this study: PubMed 39008067Rosar 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.
- Derived from this study: PubMed 38769643Rosar 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.
- Derived from this study: PubMed 37889298Burgard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samer Ezziddin, MSc, MD, PhD principal investigator
Universität des Saarlandes
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 8 Nov 2026.