Oligomet_DK: National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Procedure: RARP
Radical prostatectomy + extended pelvic lymph node dissection
Other Names:
Radiation: SBRT
Stereotactic body radiotherapy to osseous lesions
Other Names:
Drug: ADT
six month of neo-adjuvant/concomitant medical castration therapy using a gonadotropin-releasing hormone antagonist or agonist.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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: 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 [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 years or older and willing and able to provide informed consent;
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Stage cT1 ≤ cT3b, Clinical resectable
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Gleason score ≥ 6
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M1
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≤ 3 bone metastases localized to the spine, pelvis or humeral/femoral bones as evaluated by 68Ga-PSMA PET/CT and magnetic resonance imaging (MRi)
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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.
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No visceral metastasis
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Metastases suitable for stereotactic body radiotherapy
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Non symptomatic bone lesions
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Eligible for surgery
Exclusion Criteria:
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Prior curative intended treatment for prostate cancer
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Prior androgen deprivation therapy (ADT)
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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.
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Eastern Cooperative Oncology Group (ECOG) Performance Status > 1
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Evaluated not able to fulfil the study protocol.
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Contraindications against MRI
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Herlev and Gentofte Hospital | Herlev | Denmark | 2730 |
Sponsors and Collaborators
- Peter Busch Østergren
Investigators
- Principal Investigator: Peter B Østergren, MD, Herlev and Gentofte Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Oligomet_DK