Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04086290

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Prostate Cancer Metastatic

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Herlev and Gentofte Hospital

Herlev, 2730, Denmark

Location status: Recruiting

Location contact

Peter B Østergren

PRINCIPAL_INVESTIGATOR

Peter B Østergren, MD

CONTACT

+4538681505

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RARP

Procedure

Radical prostatectomy + extended pelvic lymph node dissection

Other names: Robot assisted Radical Prostatectomy

SBRT

Radiation

Stereotactic body radiotherapy to osseous lesions

Other names: Stereotactic body radiotherapy

ADT

Drug

six month of neo-adjuvant/concomitant medical castration therapy using a gonadotropin-releasing hormone antagonist or agonist.

Other names: Androgen deprivation therpay

Primary outcomes

  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 outcomes

  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 outcomes

  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:

    • 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".

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Peter B Østergren, MD

CONTACT

[email protected]

+4538681505

Sponsors and collaborators

Lead sponsor

Peter Busch Østergren

Other

Registry information

Official study title

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

Acronym: Oligomet_DK

Important dates

Study start
2019
Primary completion
2023
Study completion
2028
First posted
Sep 11, 2019
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.