Combining surgery and targeted radiotherapy for advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and feasibility of combining radical prostatectomy with stereotactic body radiotherapy (SBRT) for patients with oligometastatic prostate cancer. The study focuses on patients with a limited number of bone metastases and aims to assess the effectiveness of this combined approach alongside short-term androgen deprivation therapy. Participants will undergo imaging to confirm eligibility and will be monitored for complications and treatment outcomes throughout the trial.

Why it matters

Who can join: the full rules

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

Where it's running

• Herlev and Gentofte Hospital
  Herlev, Denmark Recruiting

Study contacts

• Principal investigator: Peter B Østergren, MD — Herlev and Gentofte Hospital
• Study coordinator: Peter B Østergren, MD
• Email: peter.busch.oestergren@regionh.dk
• Phone: +4538681505

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.