NCT04086290

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
28mo left

Started Oct 2019

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Oct 2019Oct 2028

First Submitted

Initial submission to the registry

September 2, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
29 days until next milestone

Study Start

First participant enrolled

October 10, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Expected
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

4 years

First QC Date

September 2, 2019

Last Update Submit

February 10, 2020

Conditions

Prostate Cancer Metastatic

Keywords

radiotherapyprostatectomyandrogen deprivation therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Proportion of men achieving prostatic specific antigen (PSA) < 0.1 ng/ml

    1 year

  • Feasibility of radical prostatectomy in the oligometastatic setting

    1 year

Other Outcomes (3)

  • Time to castrate resistance (TCR)

    5 yrs

  • Quality of life (FACT-P-DK)

    5 yrs

  • Number of participants with Interventions on lower or upper urinary tract

    5 yrs

Study Arms (1)

RARP + SBRT + ADT

EXPERIMENTAL

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: RARPRadiation: SBRTDrug: ADT

Interventions

RARPPROCEDURE

Radical prostatectomy + extended pelvic lymph node dissection

Also known as: Robot assisted Radical Prostatectomy
RARP + SBRT + ADT
SBRTRADIATION

Stereotactic body radiotherapy to osseous lesions

Also known as: Stereotactic body radiotherapy
RARP + SBRT + ADT
ADTDRUG

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

Also known as: Androgen deprivation therpay
RARP + SBRT + ADT

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older and willing and able to provide informed consent;
  • Stage cT1 ≤ cT3b, Clinical resectable
  • Gleason score ≥ 6
  • ≤ 3 bone metastases localized to the spine, pelvis or humeral/femoral bones as evaluated by 68Ga-PSMA PET/CT and magnetic resonance imaging (MRi)
  • 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.
  • No visceral metastasis
  • Metastases suitable for stereotactic body radiotherapy
  • Non symptomatic bone lesions
  • Eligible for surgery

You may not qualify if:

  • Prior curative intended treatment for prostate cancer
  • Prior androgen deprivation therapy (ADT)
  • 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.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status \> 1
  • Evaluated not able to fulfil the study protocol.
  • Contraindications against MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev and Gentofte Hospital

Herlev, 2730, Denmark

RECRUITING

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Peter B Østergren, MD

    Herlev and Gentofte Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter B Østergren, MD

CONTACT

+4538681505peter.busch.oestergren@regionh.dk

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 2, 2019

First Posted

September 11, 2019

Study Start

October 10, 2019

Primary Completion

October 1, 2023

Study Completion (Estimated)

October 1, 2028

Last Updated

February 12, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)