Prostate CancerRIALTONCT07644754
Patients With Metastasized Prostate Cancer Whose Prostate-specific Antigen-level (PSA) Remains >0,2 ng/ml After Six Months of Dual Antihormonal Therapy Will Receive Radiotherapy to the Prostate and Radiotherapy to Refractory Metastases
A study testing Radiotherapy to the prostate and to PSMA-PET positive metastases in people with Prostate Cancer and Prostate Cancer Metastatic Disease, run by University Hospital Tuebingen.
Trial summary
The goal of this clinical trial is to learn if radiotherapy to the prostate and PET-positive (positron emission tomography) metastasis will lead to radiological response on PSMA-PET (prostate specific membrane antigen-PET). Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer Metastatic Disease, Prostate Cancer Metastatic to Bone
- What is being tested?
- Radiotherapy to the prostate and to PSMA-PET positive metastases
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prostate adenocarcinoma
- de novo metastasized prostate cancer (at least 4 osseous metastases +/- lymphonodal metastases)
- first-line combined antihormonal therapy (ADT + ARPI) for six months
- PSA > 0,2 ng/ml after six months of combined ADT/ARPI therapy
- multimetastasized disease stage without visceral metastases on imaging at first diagnosis (PET, CT, or bone scan)
- <16 osseous/lymphnodal metastases on response assessment imaging (PSMA-PET/CT) after six months of combined antihormonal therapy
Who cannot join
- neuroendocrine histology
- visceral metastases (M1c)
- prior radiotherapy to the pelvis
- PSA < 0,2 ng/ml after 6 months of combined antihormonal therapy
- prior prostatectomy
- contraindication against PSMA-PET/CT and/or radiotherapy to the prostate/metastases
Show all 10Show fewer
- HIFU or TUR-P within 6 months of study treatment
- other active malignancy two years prior to study inclusion (except skin cancer in remission)
- relevant GU/GI condition (active fistula or other)
- known tumor predisposition syndrome
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Maximilian Niyazi, MD, Prof. Dr. Dipl.-Phys. contact
About this study
Official title: RIALTO: Radiotherapy in Primarily Metastasized Prostate Cancer - Image-guided Local AbLaTion of Prostate and Oligoresidual Disease
The goal of this clinical trial is to learn if radiotherapy to the prostate and PET-positive (positron emission tomography) metastasis will lead to radiological response on PSMA-PET (prostate specific membrane antigen-PET). Patients who receive combined androgen deprivation therapy for de novo metastasized prostate cancer and show an incomplete PSA-response (>0,2 ng/ml after six months) and exhibit at least four bone metastases on PET-imaging at this time point (without metastases to organs) can take part in this study.
The main questions it aims to answer are:
Read more
- Does radiotherapy to the prostate and PET-positive metastases lead to a radiological response one year after radiotherapy? Researchers will analyze PET-imaging prior to radiotherapy to the prostate and metastases and one yeare thereafter.
Participants will:
- Continue taking combined androgen-deprivation therapy
- Receive a total of three PSMA-PET/CT scans
- Receive radiotherapy to the prostate and PET-positive metastases
- Visit the clinic every three months for 36 months
- Complete quality of life questionnaires at every visit
- Being tested
- Radiotherapy to the prostate and to PSMA-PET positive metastases
- Keywords
- mHSPC, insufficient PSA-response to dual antihormonal treatment, local therapy, radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy to the prostate and to PSMA-PET positive metastasesRadiation
Patients will receive radiotherapy to the prostate and to PSMA-PET postivie Metastases
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy to the prostate and PSMA-PET/CT guided radiotherapy of refractory metastases | Experimental | Radiotherapy to the prostate and refractory metastases on PSMA-PET/CT Receives: Radiation: Radiotherapy to the prostate and to PSMA-PET positive metastases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological Progression-Free Survival
Radiological Progression-Free Survival as determined on PSMA-PET/CT according to RECIP criteria, defined as 30% response in PSA-volume
Measured: 12 months after radiotherapy of metastases
Secondary outcomes (9)
Lesion-specific response on imaging
Measured: 12 months after radiotherapy to metastases
Prostate specific antigen (PSA)
Prostate specific antigen
Measured: up to 36 months after radiotherapy to the prostate
Objective response rate
Measured: 12 months after radiotherapy to metastases
Time to next systemic therapy
Measured: up to 36 months after radiotherapy to the prostate
Overall survival
Measured: up to 36 months after radiotherapy to the prostate
Failure-free survival
Measured: up to 36 months after radiotherapy to the prostate
Progression-free survival
Measured: up to 36 months after radiotherapy to the prostate
Metastasis-free survival
Measured: up to 36 months after radiotherapy to the prostate
Prostate-cancer specific survival
Measured: up to 36 months after radiotherapy to the prostate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, University Hospital Freiburg, University Hospital Dresden, Uniklinikum Giessen und Marburg, University Hospital Augsburg
- Responsible party
- Sponsor
- Investigators
- Elgin Hoffmann, MD, Principal investigator, Department of Radiation Oncology, University Hospital Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644754
- Sponsor's protocol ID
- 430/2025BO1
- Other IDs
- DRKS00038018
- Acronym
- RIALTO
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Depending on national data security legislation for sharing individual data, providing IPD might not be permitted without explicit consent by the patients enrolled in this study.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RIALTO: Radiotherapy in Primarily Metastasized Prostate Cancer - Image-guided Local AbLaTion of Prostate and Oligoresidual Disease
- ClinicalTrials.gov ID
- NCT07644754
- Acronym / sponsor ID
- RIALTO / 430/2025BO1
- Keywords
- mHSPC, insufficient PSA-response to dual antihormonal treatment, local therapy, radiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, University Hospital Freiburg, University Hospital Dresden, Uniklinikum Giessen und Marburg, University Hospital Augsburg
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 12 Jun 2026 (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.
The goal of this clinical trial is to learn if radiotherapy to the prostate and PET-positive (positron emission tomography) metastasis will lead to radiological response on PSMA-PET (prostate specific membrane antigen-PET). Patients who receive combined androgen deprivation therapy for de novo metastasized prostate cancer and show an incomplete PSA-response (>0,2 ng/ml after six months) and exhibit at least four bone metastases on PET-imaging at this time point (without metastases to organs) can take part in this study.
The main questions it aims to answer are:
- Does radiotherapy to the prostate and PET-positive metastases lead to a radiological response one year after radiotherapy? Researchers will analyze PET-imaging prior to radiotherapy to the prostate and metastases and one yeare thereafter.
Participants will:
- Continue taking combined androgen-deprivation therapy
- Receive a total of three PSMA-PET/CT scans
- Receive radiotherapy to the prostate and PET-positive metastases
- Visit the clinic every three months for 36 months
- Complete quality of life questionnaires at every visit
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy to the prostate and PSMA-PET/CT guided radiotherapy of refractory metastases | Experimental | Radiation: Radiotherapy to the prostate and to PSMA-PET positive metastasesRadiotherapy to the prostate and refractory metastases on PSMA-PET/CT |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Prostate adenocarcinoma
- de novo metastasized prostate cancer (at least 4 osseous metastases +/- lymphonodal metastases)
- first-line combined antihormonal therapy (ADT + ARPI) for six months
- PSA > 0,2 ng/ml after six months of combined ADT/ARPI therapy
- multimetastasized disease stage without visceral metastases on imaging at first diagnosis (PET, CT, or bone scan)
Key exclusion criteria (10 listed)
- neuroendocrine histology
- visceral metastases (M1c)
- prior radiotherapy to the pelvis
- PSA < 0,2 ng/ml after 6 months of combined antihormonal therapy
- prior prostatectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiotherapy to the prostate and to PSMA-PET positive metastasesPatients will receive radiotherapy to the prostate and to PSMA-PET postivie Metastases | Radiation | Radiotherapy to the prostate and PSMA-PET/CT guided radiotherapy of refractory metastases |
Primary outcome
Radiological Progression-Free Survival
Time frame: 12 months after radiotherapy of metastases
Radiological Progression-Free Survival as determined on PSMA-PET/CT according to RECIP criteria, defined as 30% response in PSA-volume
9 secondary outcomes
Lesion-specific response on imaging
Time frame: 12 months after radiotherapy to metastases
Prostate specific antigen (PSA)
Time frame: up to 36 months after radiotherapy to the prostate
Objective response rate
Time frame: 12 months after radiotherapy to metastases
Time to next systemic therapy
Time frame: up to 36 months after radiotherapy to the prostate
Overall survival
Time frame: up to 36 months after radiotherapy to the prostate
Failure-free survival
Time frame: up to 36 months after radiotherapy to the prostate
Progression-free survival
Time frame: up to 36 months after radiotherapy to the prostate
Metastasis-free survival
Time frame: up to 36 months after radiotherapy to the prostate
Prostate-cancer specific survival
Time frame: up to 36 months after radiotherapy to the prostate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No. Depending on national data security legislation for sharing individual data, providing IPD might not be permitted without explicit consent by the patients enrolled in this study.
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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.
Maximilian Niyazi, MD, Prof. Dr. Dipl.-Phys. contact
Elgin Hoffmann, MD principal investigator
Department of Radiation Oncology, University Hospital Tübingen
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy to the prostate and to PSMA-PET positive metastases in people with Prostate Cancer and Prostate Cancer Metastatic Disease, run by University Hospital Tuebingen.
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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elgin Hoffmann, MD, Dr. med. (4970712982165, ROinfo@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological Progression-Free Survival (time frame: 12 months after radiotherapy of metastases). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2026.