RIALTO: Radiotherapy in Primarily Metastasized Prostate Cancer - Image-guided Local AbLaTion of Prostate and Oligoresidual Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 27
Study Overview
Brief 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). 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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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