Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
MALE
NCT04086290

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

Led by Peter Busch Østergren · Updated on 2020-02-12

20

Participants Needed

1

Research Sites

468 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older and willing and able to provide informed consent
  • Clinical stage cT1 to cT3b, resectable prostate cancer
  • Gleason score of 6 or higher
  • Metastatic prostate cancer (M1) with 3 or fewer bone metastases localized to spine, pelvis, or humeral/femoral bones as shown by 68Ga-PSMA PET/CT and MRI
  • No PSMA uptake in retroperitoneal lymph nodes outside extended pelvic lymph node dissection area
  • No visceral metastases
  • Bone metastases suitable for stereotactic body radiotherapy
  • Bone lesions are non-symptomatic
  • Eligible for surgery
Not Eligible

You will not qualify if you...

  • Prior curative treatment for prostate cancer
  • Prior androgen deprivation therapy (ADT)
  • History of another invasive cancer within 3 years, except fully treated cancers with low recurrence risk
  • Eastern Cooperative Oncology Group (ECOG) Performance Status greater than 1
  • Unable to comply with study protocol
  • Contraindications to MRI

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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2
3
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Trial Site Locations

Total: 1 location

1

Herlev and Gentofte Hospital

Herlev, Denmark, 2730

Actively Recruiting

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Research Team

P

Peter B Østergren, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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