Actively Recruiting
Oligometastatic Directed Radiotherapy for Patients With Castration Resistant Prostate Cancer
Led by University Medical Center Groningen · Updated on 2025-06-26
35
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the addition of metastasis-directed radiotherapy (MDRT) to the standard care for patients with metastatic castration-resistant prostate cancer (mCRPC) who show oligoprogression, defined as progression in up to three lesions seen on PSMA PET scans. This condition arises when prostate cancer becomes resistant to hormone therapy, leading to limited treatment options and a median survival of 2-3 years. The study aims to determine if MDRT can delay the need for next line systemic therapy (NEST) and improve radiological progression-free survival (rPFS). This is a single-arm, multicenter phase II trial involving 35 patients. Participants will receive MDRT targeting up to three progressive metastatic or local lesions, preferably using stereotactic body radiotherapy (SBRT). Patients included have an indication to start NEST and are currently treated with androgen deprivation therapy (ADT), alone or combined with chemotherapy or androgen receptor-targeted agents (ARTA). The study focuses on well-selected patients with oligoprogressive disease to test whether adding MDRT postpones further systemic treatment. During the study, patients will be monitored for radiological progression using PSMA PET imaging and assessed for quality of life, biochemical progression, overall survival, and treatment-related toxicities up to 36 months. Primary outcomes include NEST-free survival and radiological progression-free survival measured at 6, 12, and 24 months. Safety assessments will track gastrointestinal and genitourinary toxicities for up to two years after radiotherapy. This comprehensive follow-up aims to evaluate the potential benefits and risks of MDRT in this patient group.
CONDITIONS
Brief Title
The Impact of Metastatic Directed Radiotherapy (MDRT) on Oligoprogressive Castration Resistant Prostate Cancer (CRPC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with adenocarcinoma of the prostate.
- Have metastatic castration-resistant prostate cancer with testosterone level below 50 ng/dl or 1.7 nmol/l.
- Have oligoprogressive disease shown on PSMA scan with up to 3 lesions including metastases or local relapse.
- Currently receiving androgen deprivation therapy, alone or combined with androgen receptor-targeted agents or chemotherapy.
- Completed or stopped chemotherapy before starting this study.
- If treated with androgen receptor-targeted agents, have at least 3 months of response.
- Have a WHO performance status of 0-2.
- Are 18 years of age or older.
- Presented at a multidisciplinary tumor board at the treating hospital.
- Able to provide written informed consent according to regulations.
You will not qualify if you...
- Serum testosterone level above 50 ng/ml or 1.7 nmol/l.
- More than 3 progressive or new metastatic lesions and/or local recurrence.
- Active cancer other than prostate cancer that may interfere with trial results, except certain skin or urothelial cancers.
- Local recurrence in the prostate after previous radiotherapy.
- Previous treatments or health conditions that prevent receiving new metastasis-directed radiotherapy.
- Inability to understand or sign informed consent.
- Presence of PSMA-negative disease.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of radiotherapy treatment period
Participants receive metastasis directed radiotherapy (MDRT) to up to 3 oligometastatic lesions or local recurrence to delay the start of next line systemic therapy and prolong radiological progression-free survival.
Approximately 1 to 3 radiotherapy sessions depending on lesions treated
Duration - Up to 36 months after treatment
Participants are monitored for progression, quality of life, and possible toxicities for up to 36 months after treatment.
Visits at baseline, 6 months, 12 months, and 24 months; additional visits as needed for safety monitoring
Trial Site Locations
Total: 2 locations
1
UMC Groningen
Groningen, Netherlands
Actively Recruiting
2
Radboud Umc
Nijmegen, Netherlands
Not Yet Recruiting
Research Team
S
Shafak Aluwini
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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