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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
Sponsor:
Information provided by (Responsible Party):
Peter Busch Østergren, Herlev Hospital

Study Description
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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
Prostate Cancer Metastatic Procedure: RARP Radiation: SBRT Drug: ADT Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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 Name: Robot assisted Radical Prostatectomy

Radiation: SBRT
Stereotactic body radiotherapy to osseous lesions
Other Name: Stereotactic body radiotherapy

Drug: ADT
six month of neo-adjuvant/concomitant medical castration therapy using a gonadotropin-releasing hormone antagonist or agonist.
Other Name: Androgen deprivation therpay


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.


Other Outcome Measures:
  1. 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).

  2. 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:

    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".

  3. 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
    • Nephrostomy
    • Transurethral resection of the prostate (TURP) or related procedure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Peter B Østergren, MD +4538681505 peter.busch.oestergren@regionh.dk

Locations
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Denmark
Herlev and Gentofte Hospital Recruiting
Herlev, Denmark, 2730
Contact: Peter B Østergren, MD    +4538681505      
Principal Investigator: Peter B Østergren         
Sponsors and Collaborators
Peter Busch Østergren
Investigators
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Principal Investigator: Peter B Østergren, MD Herlev and Gentofte Hospital
More Information
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Responsible Party: Peter Busch Østergren, Principal Investigator, Herlev Hospital
ClinicalTrials.gov Identifier: NCT04086290    
Other Study ID Numbers: Oligomet_DK
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter Busch Østergren, Herlev Hospital:
radiotherapy
prostatectomy
androgen deprivation therapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs