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

Prostate Cancer Metastatic Clinical Trial

— Oligomet_DK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04086290
• Other study ID #: Oligomet_DK
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 10, 2019
• Est. completion date: October 2028

Study information

• Verified date: February 2020
• Source: Herlev Hospital
• Contact: Peter B Østergren, MD
• Phone: +4538681505
• Email: peter.busch.oestergren[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2028
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer Metastatic
• Prostatic Neoplasms

Intervention

Procedure:
• RARP
Radical prostatectomy + extended pelvic lymph node dissection

Radiation:
• SBRT
Stereotactic body radiotherapy to osseous lesions

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

Locations

Country	Name	City	State
Denmark	Herlev and Gentofte Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Peter Busch Østergren

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to castrate resistance (TCR)	Time to castrate resistance (TCR) measured from the primary initiation of ADT to Castrate Resistant Prostate Cancer (CRPC) defined as: Three consecutive rises in PSA one week apart resulting in two 50% increases over the nadir, with PSA > 1 ng/mL or the appearance of two or more new bone lesions on bone scan or enlargement of a soft tissue lesion using RECIST. At the same time serum testosterone is <50ng/dL (<1.70 nnmol/L).	5 yrs
Other	Quality of life (FACT-P-DK)	Changes in Quality of life assessed by the questionaire FACT-P-DK and calculated using the FACT-P Scoring Guidelines (Version 4). The following scores will be evaluated: FACT-P Trial Outcome Index (TOI). Score range: 0-104 (The higher score the better). Combines the subscales "Physical well-being", "Functional Well-being" and "Prostate Cancer Subscale"; FACT-G total score. Score range: 0-108 (the higher score the better QoL). Combines the subscales: "Physical well-being", "Social well-being", "Emotional well-being" and "Functional well-being".; FACT-P total score. Score range: 0-156 (the higher score the better QoL). Combines the subscales: "Physical well-being", "Social well-being", "Emotional well-being", "Prostate Cancer Subscale" and "Functional well-being".	5 yrs
Other	Number of participants with Interventions on lower or upper urinary tract	Number of participants undergoing with interventions on lower or upper urinary tract, i.e.: Bladder catheter; Ureteric stent; Nephrostomy; Transurethral resection of the prostate (TURP) or related procedure	5 yrs
Primary	Proportion of men with Grade = 3 adverse events the first year	Proportion of men with Grade = 3 adverse events the first year	1 year
Secondary	Proportion of men achieving prostatic specific antigen (PSA) < 0.1 ng/ml	Proportion of men achieving prostatic specific antigen (PSA) < 0.1 ng/ml	1 year
Secondary	Feasibility of radical prostatectomy in the oligometastatic setting	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.	1 year