Clinical trial · Interventional
National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients
Oligomet-DK. National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients
NCT04086290CI-TRIAL-00043351Oligomet_DKrecruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A prospective, open label phase 2 clinical trial assessing safety, complications and feasibility of radical prostatectomy (RARP) plus local stereotactic body radiotherapy (SBRT) to bone metastases in combination with short-term medical castration to a select population of prostate cancer patients with oligometastatic disease.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADT | Drug | — | UNRESOLVED |
| RARP | Procedure | — | UNRESOLVED |
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RARP + SBRT + ADT
- description
- Radical prostatectomy + extended pelvic lymph node dissection according to EAU guidelines followed by stereotactic body radiotherapy to osseous lesions with six month of neo-adjuvant/concomitant medical castration therapy using a gonadotropin-releasing hormone antagonist or agonist.
- interventionNames
- Procedure: RARP
- Radiation: SBRT
- Drug: ADT
Primary outcomes (1)
- measure
- Proportion of men with Grade ≥ 3 adverse events the first year
- timeFrame
- 1 year
- description
- Proportion of men with Grade ≥ 3 adverse events the first year
Secondary outcomes (2)
- measure
- Proportion of men achieving prostatic specific antigen (PSA) < 0.1 ng/ml
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.