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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer Metastatic
• Intervention / Treatment: Procedure: RARP; Radiation: SBRT; Drug: ADT

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Peter B Østergren, MD; Phone Number: +4538681505; Email: peter.busch.oestergren@regionh.dk

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Recruiting
    • Herlev and Gentofte Hospital
    • Contact: Peter B Østergren, MD; Phone Number: +4538681505
    • Principal Investigator: Peter B Østergren

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Procedure: RARP; Radical prostatectomy + extended pelvic lymph node dissection; Other Names: Robot assisted Radical Prostatectomy; Radiation: SBRT; Stereotactic body radiotherapy to osseous lesions; Other Names: Stereotactic body radiotherapy; Drug: ADT; six month of neo-adjuvant/concomitant medical castration therapy using a gonadotropin-releasing hormone antagonist or agonist.; Other Names: Androgen deprivation therpay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Peter Busch Østergren
• Investigators: Principal Investigator: Peter B Østergren, MD, Herlev and Gentofte Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2019
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2028

Study Registration Dates

• First Submitted: September 2, 2019
• First Submitted That Met QC Criteria: September 10, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: radiotherapy; androgen deprivation therapy; prostatectomy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens
• Other Study ID Numbers: Oligomet_DK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No