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Not yet recruiting NCT07644754

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

No phase Interventional Prostate Cancer Prostate Cancer Metastatic Disease Prostate Cancer Metastatic to Bone

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiotherapy to the prostate and to PSMA-PET positive metastases.
Who it may be relevant to
Registry conditions: Prostate Cancer, Prostate Cancer Metastatic Disease, Prostate Cancer Metastatic to Bone. Basic parameters: 18 years — 85 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

RIALTO: Radiotherapy in Primarily Metastasized Prostate Cancer - Image-guided Local AbLaTion of Prostate and Oligoresidual Disease

Overview

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

Interventions

  • Radiation Radiotherapy to the prostate and to PSMA-PET positive metastases
    Patients will receive radiotherapy to the prostate and to PSMA-PET postivie Metastases

Primary outcome measures

  • Radiological Progression-Free Survival [Time frame: 12 months after radiotherapy of metastases]
Secondary outcome measures (9)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07644754 · 430/2025BO1 · DRKS00038018

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗