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National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients (Oligomet_DK)

Primary Purpose

Prostate Cancer Metastatic

Status
Recruiting
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
RARP
SBRT
ADT
Sponsored by
Peter Busch Østergren
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer Metastatic focused on measuring radiotherapy, prostatectomy, androgen deprivation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Herlev and Gentofte HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RARP + SBRT + ADT

Arm Description

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.

Outcomes

Primary Outcome Measures

Proportion of men with Grade ≥ 3 adverse events the first 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
Proportion of men achieving prostatic specific antigen (PSA) < 0.1 ng/ml
Feasibility of radical prostatectomy in the oligometastatic setting
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.

Full Information

First Posted
September 2, 2019
Last Updated
February 10, 2020
Sponsor
Peter Busch Østergren
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1. Study Identification

Unique Protocol Identification Number
NCT04086290
Brief Title
National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients
Acronym
Oligomet_DK
Official Title
Oligomet-DK. National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter Busch Østergren

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Metastatic
Keywords
radiotherapy, prostatectomy, androgen deprivation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RARP + SBRT + ADT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
RARP
Other Intervention Name(s)
Robot assisted Radical Prostatectomy
Intervention Description
Radical prostatectomy + extended pelvic lymph node dissection
Intervention Type
Radiation
Intervention Name(s)
SBRT
Other Intervention Name(s)
Stereotactic body radiotherapy
Intervention Description
Stereotactic body radiotherapy to osseous lesions
Intervention Type
Drug
Intervention Name(s)
ADT
Other Intervention Name(s)
Androgen deprivation therpay
Intervention Description
six month of neo-adjuvant/concomitant medical castration therapy using a gonadotropin-releasing hormone antagonist or agonist.
Primary Outcome Measure Information:
Title
Proportion of men with Grade ≥ 3 adverse events the first year
Description
Proportion of men with Grade ≥ 3 adverse events the first year
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Proportion of men achieving prostatic specific antigen (PSA) < 0.1 ng/ml
Description
Proportion of men achieving prostatic specific antigen (PSA) < 0.1 ng/ml
Time Frame
1 year
Title
Feasibility of radical prostatectomy in the oligometastatic setting
Description
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 Frame
1 year
Other Pre-specified Outcome Measures:
Title
Time to castrate resistance (TCR)
Description
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).
Time Frame
5 yrs
Title
Quality of life (FACT-P-DK)
Description
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".
Time Frame
5 yrs
Title
Number of participants with Interventions on lower or upper urinary tract
Description
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
Time Frame
5 yrs

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older and willing and able to provide informed consent; Stage cT1 ≤ cT3b, Clinical resectable Gleason score ≥ 6 M1 ≤ 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter B Østergren, MD
Phone
+4538681505
Email
peter.busch.oestergren@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter B Østergren, MD
Organizational Affiliation
Herlev and Gentofte Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev and Gentofte Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter B Østergren, MD
Phone
+4538681505
First Name & Middle Initial & Last Name & Degree
Peter B Østergren

12. IPD Sharing Statement

Plan to Share IPD
No

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National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients

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