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

NCT ID: NCT04086290

Last Updated: 2020-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-10
• Study Completion Date: 2028-10-31

Brief 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.

Conditions

Prostate Cancer Metastatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RARP + SBRT + ADT

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.

Group Type: EXPERIMENTAL

RARP

Intervention Type: PROCEDURE

Radical prostatectomy + extended pelvic lymph node dissection

SBRT

Intervention Type: RADIATION

Stereotactic body radiotherapy to osseous lesions

ADT

Intervention Type: DRUG

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

Interventions

RARP

Radical prostatectomy + extended pelvic lymph node dissection

Intervention Type: PROCEDURE

SBRT

Stereotactic body radiotherapy to osseous lesions

Intervention Type: RADIATION

ADT

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

Intervention Type: DRUG

Other Intervention Names

Robot assisted Radical Prostatectomy; Stereotactic body radiotherapy; Androgen deprivation therpay

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Peter Busch Østergren

OTHER

Sponsor Role: lead

Responsible Party

Peter Busch Østergren

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Peter B Østergren, MD

Role: PRINCIPAL_INVESTIGATOR

Herlev and Gentofte Hospital

Locations

Herlev and Gentofte Hospital

Herlev, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Peter B Østergren, MD

Role: CONTACT

peter.busch.oestergren@regionh.dk

+4538681505

Facility Contacts

Peter B Østergren, MD

Role: primary

+4538681505

Other Identifiers

Oligomet_DK

Identifier Type: -

Identifier Source: org_study_id