National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients
Oligomet-DK. National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients
About This Trial
- This clinical trial is studying a treatment combination that includes surgery to remove the prostate, targeted radiation to areas where cancer has spread to the bones, and short-term hormone therapy.
- Researchers want to see if combining these treatments is safe and practical for patients.
- It is designed for people whose prostate cancer has spread to only a few bone spots (up to three) and has not spread to other organs.
- Before considering this study, patients should know that it involves major surgery and is only for those who have not yet received prior hormone therapy or curative treatments for their cancer.
More Information
- 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.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This clinical trial is studying a treatment combination that includes surgery to remove the prostate, targeted radiation to areas where cancer has spread to the bones, and short-term hormone therapy.
Study Details
- Start Date: October 10, 2019
- Lead Sponsor: Peter Busch Østergren
Full Eligibility Criteria
Inclusion Criteria
- Age 18 years or older and willing and able to provide informed consent;
- Stage cT1 ≤ cT3b, Clinical resectable
- Gleason score ≥ 6
- M1
- ≤ 3 bone metastases localized to the spine, pelvis or humeral/femoral bones as evaluated by 68Ga-PSMA PET/CT and magnetic resonance imaging (MRi)
- 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.
- No visceral metastasis
- Metastases suitable for stereotactic body radiotherapy
- Non symptomatic bone lesions
- Eligible for surgery
Exclusion Criteria
- Prior curative intended treatment for prostate cancer
- Prior androgen deprivation therapy (ADT)
- 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.
- Eastern Cooperative Oncology Group (ECOG) Performance Status > 1
- Evaluated not able to fulfil the study protocol.
- Contraindications against MRI
Treatments
- Procedure: RARP
- Radiation: SBRT
- Drug: ADT