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

Phase 1

Recruiting

• Conditions: Prostate Cancer Metastatic
• Interventions: Procedure: RARP; Radiation: SBRT; Drug: ADT

• Registration Number: NCT04086290
• Lead Sponsor: Peter Busch Østergren

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-02
• Study First Submitted QC: 2019-09-10
• Study First Posted: 2019-09-11
• Study Start: 2019-10-10
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-12
• Primary Completion: 2023-10
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RARP + SBRT + ADT	RARP	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.
RARP + SBRT + ADT	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.
RARP + SBRT + ADT	SBRT	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.

Primary Outcome Measures

Name	Time	Method
Proportion of men with Grade ≥ 3 adverse events the first year	1 year	Proportion of men with Grade ≥ 3 adverse events the first year

Secondary Outcome Measures

Name	Time	Method
Proportion of men achieving prostatic specific antigen (PSA) < 0.1 ng/ml	1 year	Proportion of men achieving prostatic specific antigen (PSA) \< 0.1 ng/ml
Feasibility of radical prostatectomy in the oligometastatic setting	1 year	Feasibility of radical prostatectomy in the oligometastatic setting measured as number of patients who successfully undergo radical prostatectomy with pelvic lymphnode disection and 30 days (post-operative) morbidity according to the Clavian Dindo Classification.

Trial Locations

Locations (1)

Herlev and Gentofte Hospital; 🇩🇰 Herlev, Denmark