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

February 10, 2020 updated by: Peter Busch Østergren

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Recruiting
        • Herlev and Gentofte Hospital
        • Contact:
          • Peter B Østergren, MD
          • Phone Number: +4538681505
        • Principal Investigator:
          • Peter B Østergren

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:
  • Robot assisted Radical Prostatectomy
Radiation: SBRT
Stereotactic body radiotherapy to osseous lesions
Other Names:
  • Stereotactic body radiotherapy
Drug: ADT
six month of neo-adjuvant/concomitant medical castration therapy using a gonadotropin-releasing hormone antagonist or agonist.
Other Names:
  • Androgen deprivation therpay

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
1 year
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.
1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
5 yrs
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".
5 yrs
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
5 yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peter Busch Østergren

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter B Østergren, MD, Herlev and Gentofte Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Oligomet_DK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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