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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RARP + SBRT + ADT | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RARP | Procedure | Radical prostatectomy + extended pelvic lymph node dissection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of men with Grade ≥ 3 adverse events the first year | Proportion of men with Grade ≥ 3 adverse events the first year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of men achieving prostatic specific antigen (PSA) < 0.1 ng/ml | Proportion of men achieving prostatic specific antigen (PSA) < 0.1 ng/ml | 1 year |
| Feasibility of radical prostatectomy in the oligometastatic setting |
| Measure | Description | Time Frame |
|---|---|---|
| Time to castrate resistance (TCR) | 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). |
Inclusion Criteria:
Age 18 years or older and willing and able to provide informed consent;
Stage cT1 ≤ cT3b, Clinical resectable
Gleason score ≥ 6
M1
Eligible for surgery
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter B Østergren, MD | Contact | +4538681505 | peter.busch.oestergren@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Peter B Østergren, MD | Herlev and Gentofte Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev and Gentofte Hospital | Recruiting | Herlev | 2730 | Denmark |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| SBRT | Radiation | Stereotactic body radiotherapy to osseous lesions |
|
|
| ADT | Drug | six month of neo-adjuvant/concomitant medical castration therapy using a gonadotropin-releasing hormone antagonist or agonist. |
|
|
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.
| 1 year |
| 5 yrs |
| Quality of life (FACT-P-DK) | 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:
| 5 yrs |
| Number of participants with Interventions on lower or upper urinary tract | Number of participants undergoing with interventions on lower or upper urinary tract, i.e.:
| 5 yrs |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |