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Clinical Trials in Denmark / NCT04086290
Recruiting Phase 1/2

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

NCT04086290 · tracked via the Priya Life Science Denmark tracker
Sponsor
Peter Busch Østergren
Phase
Phase 1/2
Started
2019-10-10
Last updated
2020-02-12

Condition(s) studied

Prostate Cancer Metastatic

Investigational drug(s) / intervention(s)

RARPSBRTADT

RARP: Radical prostatectomy + extended pelvic lymph node dissection

SBRT: Stereotactic body radiotherapy to osseous lesions

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

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Proportion of men with Grade ≥ 3 adverse events the first year — 1 year
    Proportion of men with Grade ≥ 3 adverse events the first year

Trial sites (1)

FacilityCityRegionStatus
Herlev and Gentofte Hospital Herlev Denmark Recruiting

Other trials for the same condition

Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04086290 on ClinicalTrials.gov ↗ ← All trials in Denmark