National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients (Oligomet_DK)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04086290|
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Metastatic||Procedure: RARP Radiation: SBRT Drug: ADT||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Oligomet-DK. National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients|
|Estimated Study Start Date :||September 9, 2019|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||October 2028|
Experimental: RARP + SBRT + ADT
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.
Radical prostatectomy + extended pelvic lymph node dissection
Other Name: Robot assisted Radical Prostatectomy
Stereotactic body radiotherapy to osseous lesions
Other Name: Stereotactic body radiotherapy
six month of neo-adjuvant/concomitant medical castration therapy using a gonadotropin-releasing hormone antagonist or agonist.
Other Name: Androgen deprivation therpay
- Proportion of men with Grade ≥ 3 adverse events the first year [ Time Frame: 1 year ]Proportion of men with Grade ≥ 3 adverse events the first year
- Proportion of men achieving prostatic specific antigen (PSA) < 0.1 ng/ml [ Time Frame: 1 year ]Proportion of men achieving prostatic specific antigen (PSA) < 0.1 ng/ml
- Feasibility of radical prostatectomy in the oligometastatic setting [ Time Frame: 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.
- Time to castrate resistance (TCR) [ Time Frame: 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) [ Time Frame: 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:
- 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"
- 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".
- 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 [ Time Frame: 5 yrs ]
Number of participants undergoing with interventions on lower or upper urinary tract, i.e.:
- Bladder catheter
- Ureteric stent
- Transurethral resection of the prostate (TURP) or related procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086290
|Contact: Peter B Østergren, MDemail@example.com|
|Herlev and Gentofte Hospital||Recruiting|
|Herlev, Denmark, 2730|
|Contact: Peter B Østergren, MD +4538681505|
|Principal Investigator: Peter B Østergren|
|Principal Investigator:||Peter B Østergren, MD||Herlev and Gentofte Hospital|