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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oligomet-DK. National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT04086290
- Acronym / sponsor ID
- Oligomet_DK / Oligomet_DK
- Conditions
- Prostate Cancer Metastatic
- Keywords
- radiotherapy, prostatectomy, androgen deprivation therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peter Busch ØstergrenUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RARP + SBRT + ADT | Experimental | Procedure: RARP, Radiation: SBRT, Drug: ADTRadical 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 years or older and willing and able to provide informed consent;
- Stage cT1 ≤ cT3b, Clinical resectable
- Gleason score ≥ 6
- M1
- Eligible for surgery
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RARPAlso: Robot assisted Radical ProstatectomyRadical prostatectomy + extended pelvic lymph node dissection | Procedure or surgery | RARP + SBRT + ADT |
| SBRTAlso: Stereotactic body radiotherapyStereotactic body radiotherapy to osseous lesions | Radiation | RARP + SBRT + ADT |
| ADTAlso: Androgen deprivation therpaysix month of neo-adjuvant/concomitant medical castration therapy using a gonadotropin-releasing hormone antagonist or agonist. | Drug | RARP + SBRT + ADT |
Primary outcome
Proportion of men with Grade ≥ 3 adverse events the first year
Time frame: 1 year
Proportion of men with Grade ≥ 3 adverse events the first year
2 secondary outcomes
Proportion of men achieving prostatic specific antigen (PSA) < 0.1 ng/ml
Time frame: 1 year
Feasibility of radical prostatectomy in the oligometastatic setting
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter B Østergren, MD principal investigator
Herlev and Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter B Østergren, MD (+4538681505, peter.busch.oestergren@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of men with Grade ≥ 3 adverse events the first year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.