NCT04086290 National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients
| NCT ID | NCT04086290 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Peter Busch Østergren |
| Condition | Prostate Cancer Metastatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2019-10-10 |
| Primary Completion | 2023-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2019-10-10 with a primary completion date of 2023-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Peter B Østergren, MD
PRINCIPAL INVESTIGATOR
Herlev and Gentofte Hospital
Frequently Asked Questions
Who can join the NCT04086290 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04086290 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04086290 currently recruiting?
Yes, NCT04086290 is actively recruiting participants. Contact the research team at peter.busch.oestergren@regionh.dk for enrollment information.
Where is the NCT04086290 trial being conducted?
This trial is being conducted at Herlev, Denmark.
Who is sponsoring the NCT04086290 clinical trial?
NCT04086290 is sponsored by Peter Busch Østergren. The principal investigator is Peter B Østergren, MD at Herlev and Gentofte Hospital. The trial plans to enroll 20 participants.
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