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 uppdaterad 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
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
27
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Elgin Hoffmann, MD, Dr. med.
- Telefonnummer: 4970712982165
- E-post: ROinfo@med.uni-tuebingen.de
Studera Kontakt Backup
- Namn: Maximilian Niyazi, MD, Prof. Dr. Dipl.-Phys.
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Radiological Progression-Free Survival
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Lesion-specific response on imaging
Tidsram: 12 months after radiotherapy to metastases
|
12 months after radiotherapy to metastases
|
|
|
Prostate specific antigen (PSA)
Tidsram: up to 36 months after radiotherapy to the prostate
|
Prostate specific antigen
|
up to 36 months after radiotherapy to the prostate
|
|
Objective response rate
Tidsram: 12 months after radiotherapy to metastases
|
12 months after radiotherapy to metastases
|
|
|
Time to next systemic therapy
Tidsram: up to 36 months after radiotherapy to the prostate
|
up to 36 months after radiotherapy to the prostate
|
|
|
Overall survival
Tidsram: up to 36 months after radiotherapy to the prostate
|
up to 36 months after radiotherapy to the prostate
|
|
|
Failure-free survival
Tidsram: up to 36 months after radiotherapy to the prostate
|
up to 36 months after radiotherapy to the prostate
|
|
|
Progression-free survival
Tidsram: up to 36 months after radiotherapy to the prostate
|
up to 36 months after radiotherapy to the prostate
|
|
|
Metastasis-free survival
Tidsram: up to 36 months after radiotherapy to the prostate
|
up to 36 months after radiotherapy to the prostate
|
|
|
Prostate-cancer specific survival
Tidsram: up to 36 months after radiotherapy to the prostate
|
up to 36 months after radiotherapy to the prostate
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Quality of life questionnaires
Tidsram: 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
Tidsram: up to 36 months after radiotherapy of the prostate
|
CTCAEv5
|
up to 36 months after radiotherapy of the prostate
|
|
Organ function
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: up to 36 months after radiotherapy to the prostate
|
EQ-D5
|
up to 36 months after radiotherapy to the prostate
|
|
Organ-specific side effects
Tidsram: up to 36 months after end of radiotherapy
|
RTOG questionnaire
|
up to 36 months after end of radiotherapy
|
|
Organ function
Tidsram: up to 36 months after radiotherapy to the prostate
|
ICIQScore
|
up to 36 months after radiotherapy to the prostate
|
|
Organ-specific function
Tidsram: up to 36 months after radiotherapy to the prostate
|
NCI-PRO-CTCAE
|
up to 36 months after radiotherapy to the prostate
|
|
Organ-specific function
Tidsram: up to 36 months after radiotherapy to the prostate
|
IIEF
|
up to 36 months after radiotherapy to the prostate
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Elgin Hoffmann, MD, Department of Radiation Oncology, University Hospital Tübingen
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juli 2026
Primärt slutförande (Beräknad)
1 juli 2027
Avslutad studie (Beräknad)
1 februari 2031
Studieregistreringsdatum
Först inskickad
1 juni 2026
Först inskickad som uppfyllde QC-kriterierna
8 juni 2026
Första postat (Faktisk)
12 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 430/2025BO1
- DRKS00038018 (Registeridentifierare: Deutsches Register Klinischer Studien (German clinical trial registry))
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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