Prostate Cancer Metastatic
Conditions
Keywords
radiotherapy, prostatectomy, androgen deprivation therapy
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.
Interventions
PROCEDURERARP
Radical prostatectomy + extended pelvic lymph node dissection
RADIATIONSBRT
Stereotactic body radiotherapy to osseous lesions
DRUGADT
six month of neo-adjuvant/concomitant medical castration therapy using a gonadotropin-releasing hormone antagonist or agonist.
Sponsors
Peter Busch Østergren
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of men with Grade ≥ 3 adverse events the first year | 1 year | Proportion of men with Grade ≥ 3 adverse events the first year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of men achieving prostatic specific antigen (PSA) < 0.1 ng/ml | 1 year | Proportion of men achieving prostatic specific antigen (PSA) \< 0.1 ng/ml |
| Feasibility of radical prostatectomy in the oligometastatic setting | 1 year | Feasibility of radical prostatectomy in the oligometastatic setting measured as number of patients who successfully undergo radical prostatectomy with pelvic lymphnode disection and 30 days (post-operative) morbidity according to the Clavian Dindo Classification. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to castrate resistance (TCR) | 5 yrs | Time to castrate resistance (TCR) measured from the primary initiation of ADT to Castrate Resistant Prostate Cancer (CRPC) defined as: Three consecutive rises in PSA one week apart resulting in two 50% increases over the nadir, with PSA \> 1 ng/mL or the appearance of two or more new bone lesions on bone scan or enlargement of a soft tissue lesion using RECIST. At the same time serum testosterone is \<50ng/dL (\<1.70 nnmol/L). |
| Quality of life (FACT-P-DK) | 5 yrs | Changes in Quality of life assessed by the questionaire FACT-P-DK and calculated using the FACT-P Scoring Guidelines (Version 4). The following scores will be evaluated: 1. FACT-P Trial Outcome Index (TOI). Score range: 0-104 (The higher score the better). Combines the subscales Physical well-being, Functional Well-being and Prostate Cancer Subscale 2. FACT-G total score. Score range: 0-108 (the higher score the better QoL). Combines the subscales: Physical well-being, Social well-being, Emotional well-being and Functional well-being. 3. FACT-P total score. Score range: 0-156 (the higher score the better QoL). Combines the subscales: Physical well-being, Social well-being, Emotional well-being, Prostate Cancer Subscale and Functional well-being. |
| Number of participants with Interventions on lower or upper urinary tract | 5 yrs | Number of participants undergoing with interventions on lower or upper urinary tract, i.e.: * Bladder catheter * Ureteric stent * Nephrostomy * Transurethral resection of the prostate (TURP) or related procedure |
Countries
Denmark
Contacts
Primary ContactPeter B Østergren, MD
Outcome results
None listed