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 (RIALTO)
8. juni 2026 opdateret af: University Hospital Tuebingen
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:
• 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
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
27
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Elgin Hoffmann, MD, Dr. med.
- Telefonnummer: 4970712982165
- E-mail: ROinfo@med.uni-tuebingen.de
Undersøgelse Kontakt Backup
- Navn: Maximilian Niyazi, MD, Prof. Dr. Dipl.-Phys.
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Radiotherapy to the prostate and PSMA-PET/CT guided radiotherapy of refractory metastases
Radiotherapy to the prostate and refractory metastases on PSMA-PET/CT
|
Patients will receive radiotherapy to the prostate and to PSMA-PET postivie Metastases
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Radiological Progression-Free Survival
Tidsramme: 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
|
12 months after radiotherapy of metastases
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Lesion-specific response on imaging
Tidsramme: 12 months after radiotherapy to metastases
|
12 months after radiotherapy to metastases
|
|
|
Prostate specific antigen (PSA)
Tidsramme: up to 36 months after radiotherapy to the prostate
|
Prostate specific antigen
|
up to 36 months after radiotherapy to the prostate
|
|
Objective response rate
Tidsramme: 12 months after radiotherapy to metastases
|
12 months after radiotherapy to metastases
|
|
|
Time to next systemic therapy
Tidsramme: up to 36 months after radiotherapy to the prostate
|
up to 36 months after radiotherapy to the prostate
|
|
|
Overall survival
Tidsramme: up to 36 months after radiotherapy to the prostate
|
up to 36 months after radiotherapy to the prostate
|
|
|
Failure-free survival
Tidsramme: up to 36 months after radiotherapy to the prostate
|
up to 36 months after radiotherapy to the prostate
|
|
|
Progression-free survival
Tidsramme: up to 36 months after radiotherapy to the prostate
|
up to 36 months after radiotherapy to the prostate
|
|
|
Metastasis-free survival
Tidsramme: up to 36 months after radiotherapy to the prostate
|
up to 36 months after radiotherapy to the prostate
|
|
|
Prostate-cancer specific survival
Tidsramme: up to 36 months after radiotherapy to the prostate
|
up to 36 months after radiotherapy to the prostate
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of life questionnaires
Tidsramme: up to 36 months after radiotherapy of the prostate
|
EORTC QLQ-C30 Prostate
|
up to 36 months after radiotherapy of the prostate
|
|
Organ-specific side effects
Tidsramme: up to 36 months after radiotherapy of the prostate
|
CTCAEv5
|
up to 36 months after radiotherapy of the prostate
|
|
Organ function
Tidsramme: up to 36 months after radiotherapy of the prostate
|
IPS-Score
|
up to 36 months after radiotherapy of the prostate
|
|
Choice of next systemic therapy
Tidsramme: up to 36 months after radiotherapy to the prostate
|
Documentation of systemic treatment in case of progression
|
up to 36 months after radiotherapy to the prostate
|
|
Reason for change in systemic therapy
Tidsramme: up to 36 months after radiotherapy to the prostate
|
Documentation in case of change in systemic therapy
|
up to 36 months after radiotherapy to the prostate
|
|
Quality of Life questionnaire
Tidsramme: up to 36 months after end of radiotherapy of the prostate
|
QLQ-PR25
|
up to 36 months after end of radiotherapy of the prostate
|
|
Quality of life questionnaire
Tidsramme: up to 36 months after radiotherapy to the prostate
|
EQ-D5
|
up to 36 months after radiotherapy to the prostate
|
|
Organ-specific side effects
Tidsramme: up to 36 months after end of radiotherapy
|
RTOG questionnaire
|
up to 36 months after end of radiotherapy
|
|
Organ function
Tidsramme: up to 36 months after radiotherapy to the prostate
|
ICIQScore
|
up to 36 months after radiotherapy to the prostate
|
|
Organ-specific function
Tidsramme: up to 36 months after radiotherapy to the prostate
|
NCI-PRO-CTCAE
|
up to 36 months after radiotherapy to the prostate
|
|
Organ-specific function
Tidsramme: up to 36 months after radiotherapy to the prostate
|
IIEF
|
up to 36 months after radiotherapy to the prostate
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Elgin Hoffmann, MD, Department of Radiation Oncology, University Hospital Tübingen
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juli 2026
Primær færdiggørelse (Anslået)
1. juli 2027
Studieafslutning (Anslået)
1. februar 2031
Datoer for studieregistrering
Først indsendt
1. juni 2026
Først indsendt, der opfyldte QC-kriterier
8. juni 2026
Først opslået (Faktiske)
12. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 430/2025BO1
- DRKS00038018 (Registry Identifier: Deutsches Register Klinischer Studien (German clinical trial registry))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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