Prostate Cancer MetastaticPhase 1/2Oligomet_DKNCT04086290
National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients
A Phase 1/2 study testing RARP, SBRT and ADT in people with Prostate Cancer Metastatic, run by Peter Busch Østergren at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic
- What is being tested?
- RARP, SBRT and ADT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Oct 2019to Oct 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older and willing and able to provide informed consent;
- Stage cT1 ≤ cT3b, Clinical resectable
- Gleason score ≥ 6
- M1
- ≤ 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.
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- No visceral metastasis
- Metastases suitable for stereotactic body radiotherapy
- Non symptomatic bone lesions
- Eligible for surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Herlev and Gentofte Hospital
Herlev, 2730
Peter B Østergren, MD, +4538681505
Peter B Østergren
About this study
Official title: 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.
- Conditions
- Prostate Cancer Metastatic
- Being tested
- RARP, SBRT, ADT
- Keywords
- radiotherapy, prostatectomy, androgen deprivation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RARPProcedure or surgery
Also called Robot assisted Radical Prostatectomy
Radical prostatectomy + extended pelvic lymph node dissection
SBRTRadiation
Also called Stereotactic body radiotherapy
Stereotactic body radiotherapy to osseous lesions
ADTDrug
Also called Androgen deprivation therpay
six month of neo-adjuvant/concomitant medical castration therapy using a gonadotropin-releasing hormone antagonist or agonist.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: RARP; Radiation: SBRT; Drug: ADT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of men with Grade ≥ 3 adverse events the first year
Proportion of men with Grade ≥ 3 adverse events the first year
Measured: 1 year
Secondary outcomes (2)
Proportion of men achieving prostatic specific antigen (PSA) < 0.1 ng/ml
Proportion of men achieving prostatic specific antigen (PSA) < 0.1 ng/ml
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start10 Oct 2019
- Primary completionOct 2023 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter Busch Østergren
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Busch Østergren, Herlev Hospital
- Investigators
- Peter B Østergren, MD, Principal investigator, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086290
- Sponsor's protocol ID
- Oligomet_DK
- Acronym
- Oligomet_DK
- Status last verified
- Feb 2020
- First submitted
- 2 Sep 2019
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No