Combining surgery and targeted radiotherapy for advanced prostate cancer
Oligomet-DK. National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients
This study is testing whether combining surgery with targeted radiotherapy can help men with advanced prostate cancer that has spread to a few bones.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Herlev Hospital Academic / other |
| Locations | 1 site (Herlev) |
| Trial ID | NCT04086290 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and feasibility of combining radical prostatectomy with stereotactic body radiotherapy (SBRT) for patients with oligometastatic prostate cancer. The study focuses on patients with a limited number of bone metastases and aims to assess the effectiveness of this combined approach alongside short-term androgen deprivation therapy. Participants will undergo imaging to confirm eligibility and will be monitored for complications and treatment outcomes throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with oligometastatic prostate cancer, specifically those with 3 or fewer bone metastases and no visceral metastasis.
Not a fit: Patients with prior curative treatment for prostate cancer or those with symptomatic bone lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and quality of life for patients with metastatic prostate cancer.
How similar studies have performed: While there have been studies exploring similar combinations of surgery and radiotherapy, this specific approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 years or older and willing and able to provide informed consent; 2. Stage cT1 ≤ cT3b, Clinical resectable 3. Gleason score ≥ 6 4. M1 1. ≤ 3 bone metastases localized to the spine, pelvis or humeral/femoral bones as evaluated by 68Ga-PSMA PET/CT and magnetic resonance imaging (MRi) 2. Absence of PSMA uptake in retroperitoneal lymph nodes, (outside the anatomical region of extended pelvic lymph node dissection as described in the European Association of Urology (EAU) guidelines. 3. No visceral metastasis 4. Metastases suitable for stereotactic body radiotherapy 5. Non symptomatic bone lesions 5. Eligible for surgery Exclusion Criteria: 1. Prior curative intended treatment for prostate cancer 2. Prior androgen deprivation therapy (ADT) 3. History of another invasive cancer within 3 years of screening, with the exception of fully treated cancers with a remote probability of recurrence. The medical monitor and investigator must agree that the possibility of recurrence is remote for exceptions. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status \> 1 5. Evaluated not able to fulfil the study protocol. 6. Contraindications against MRI
Where this trial is running
Herlev
- Herlev and Gentofte Hospital — Herlev, Denmark (Recruiting)
Study contacts
- Principal investigator: Peter B Østergren, MD — Herlev and Gentofte Hospital
- Study coordinator: Peter B Østergren, MD
- Email: peter.busch.oestergren@regionh.dk
- Phone: +4538681505
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.