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

Peter Busch Østergren

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Prostate Cancer Metastatic

Treatments: Radiation: SBRT; Drug: ADT; Procedure: RARP

Study type: Interventional

Funder types: Other

Identifiers

NCT04086290

Oligomet_DK

Details and patient eligibility

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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

RARP + SBRT + ADT

Experimental group

Description:

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.

Treatment:

Procedure: RARP

Drug: ADT

Radiation: SBRT