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 oppdatert av: 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
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
27
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Elgin Hoffmann, MD, Dr. med.
- Telefonnummer: 4970712982165
- E-post: ROinfo@med.uni-tuebingen.de
Studer Kontakt Backup
- Navn: Maximilian Niyazi, MD, Prof. Dr. Dipl.-Phys.
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Elgin Hoffmann, MD, Department of Radiation Oncology, University Hospital Tübingen
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
1. juli 2027
Studiet fullført (Antatt)
1. februar 2031
Datoer for studieregistrering
Først innsendt
1. juni 2026
Først innsendt som oppfylte QC-kriteriene
8. juni 2026
Først lagt ut (Faktiske)
12. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 430/2025BO1
- DRKS00038018 (Registeridentifikator: Deutsches Register Klinischer Studien (German clinical trial registry))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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