National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients (Oligomet_DK)
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|ClinicalTrials.gov Identifier: NCT04086290|
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : February 12, 2020
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|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|
|Actual Study Start Date :||October 10, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- Age 18 years or older and willing and able to provide informed consent;
- Stage cT1 ≤ cT3b, Clinical resectable
- Gleason score ≥ 6
- ≤ 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
- 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
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|
|Responsible Party:||Peter Busch Østergren, Principal Investigator, Herlev Hospital|
|Other Study ID Numbers:||
|First Posted:||September 11, 2019 Key Record Dates|
|Last Update Posted:||February 12, 2020|
|Last Verified:||February 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
androgen deprivation therapy
Genital Neoplasms, Male
Neoplasms by Site
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs