Prostate Cancer RecurrentNCT03604211
SBRT for Oligometastatic Lymph Node Recurrence in Prostate Cancer: a Single Institution Experience
An observational study of Prostate Cancer Recurrent and Prostate Cancer, run by Kantonsspital Graubünden at 1 site in Switzerland.
Trial summary
Single-institution retrospective analysis for predictive factors of prostate cancer patients presenting with isolated or limited lymph node (LN) recurrence (1-3 lesions) on F-Ccholine PET-CT (CholPET) treated with SBRT between January 2010 and July 2015. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate Cancer Recurrent, Prostate Cancer, Lymph Node Metastases
- What is being tested?
- Cyberknife Radiation Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 85 years
- Men only
- Adult, Older adult
Study population: single-Institution cohort of male patients 18-85 years of age, with recurrent prostate cancer after radical prostatectomy in 1-3 lymphnodes, prospectively registered in a local institutional database
Who may be able to join
- histologically proven diagnosis of prostate cancer
- Radical prostatectomy (± salvage radiotherapy)
- PSA relapse (defined by two consecutive rising PSA values >0.2 ug/l)
- one to three lymphnodes positive on Choline-PET
- no recurrence in prostatic bed on Choline-PET
- WHO performance status of 0-1
- no previous chemotherapy or ADT for prostate cancer.
Who cannot join
- primary treatment for prostate cancer by RT or brachytherapy
- bone (M1b) metastases
- visceral (M1c) metastases
- any symptomatic nodal lesion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Factors for the Benefit of Stereotactic Body Radiotherapy for Oligometastatic Lymph Node Recurrence in Prostate Cancer: a Single Institution Experience
Single-institution retrospective analysis for predictive factors of prostate cancer patients presenting with isolated or limited lymph node (LN) recurrence (1-3 lesions) on F-Ccholine PET-CT (CholPET) treated with SBRT between January 2010 and July 2015.
Read the detailed description
Single-institution retrospective analysis of consecutive prostate cancer patients after definitive primary treatment, without local recurrence, presenting with isolated or limited lymph node (LN) recurrence (1-3 lesions) on F-Ccholine PET-CT (CholPET) treated with SBRT between January 2010 and July 2015.
Endpoints of interest are biochemical response rate (defined as a reduction by at least 10% of the initial PSA value), time to biochemical recurrence (TBR) (defined as the time interval from SBRT until second PSA rise), and time interval between SBRT and ADT start. Univariate analysis is used to identify prognostic factors.
- Being tested
- Cyberknife Radiation Therapy
- Medical subject headings
- Prostatic Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyberknife Radiation TherapyRadiation
Stereotactic Radiotherapy of lymphnode recurrence after prostatectomy +/- salvage radiotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
time to biochemical recurrence
time interval from SBRT until second PSA rise
Measured: 18 months
Secondary outcomes (2)
biochemical response rate
reduction by at least 10% of the initial PSA value
Measured: 18 months
time interval between SBRT and ADT start
time interval between SBRT and ADT start
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study startJan 2010
- Primary completionJul 2015
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer RecurrentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Graubünden
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Daniel R Zwahlen, MD, Study director, Kantonsspital Graubünden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604211
- Sponsor's protocol ID
- KGraubuenden
- Status last verified
- Aug 2018
- First submitted
- 19 Jul 2018
- Last updated
- 17 Aug 2018
- 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 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors for the Benefit of Stereotactic Body Radiotherapy for Oligometastatic Lymph Node Recurrence in Prostate Cancer: a Single Institution Experience
- ClinicalTrials.gov ID
- NCT03604211
- Acronym / sponsor ID
- KGraubuenden
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Kantonsspital GraubündenUniversity, hospital or other
- Collaborators
- Swiss Cancer Institute
- Study start
- Jan 2010 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 27 Jul 2018 (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.
Single-institution retrospective analysis for predictive factors of prostate cancer patients presenting with isolated or limited lymph node (LN) recurrence (1-3 lesions) on F-Ccholine PET-CT (CholPET) treated with SBRT between January 2010 and July 2015.
Detailed description
Single-institution retrospective analysis of consecutive prostate cancer patients after definitive primary treatment, without local recurrence, presenting with isolated or limited lymph node (LN) recurrence (1-3 lesions) on F-Ccholine PET-CT (CholPET) treated with SBRT between January 2010 and July 2015.
Endpoints of interest are biochemical response rate (defined as a reduction by at least 10% of the initial PSA value), time to biochemical recurrence (TBR) (defined as the time interval from SBRT until second PSA rise), and time interval between SBRT and ADT start. Univariate analysis is used to identify prognostic factors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- single-Institution cohort of male patients 18-85 years of age, with recurrent prostate cancer after radical prostatectomy in 1-3 lymphnodes, prospectively registered in a local institutional database
Key inclusion criteria (7 listed)
- histologically proven diagnosis of prostate cancer
- Radical prostatectomy (± salvage radiotherapy)
- PSA relapse (defined by two consecutive rising PSA values >0.2 ug/l)
- one to three lymphnodes positive on Choline-PET
- no recurrence in prostatic bed on Choline-PET
Key exclusion criteria (4 listed)
- primary treatment for prostate cancer by RT or brachytherapy
- bone (M1b) metastases
- visceral (M1c) metastases
- any symptomatic nodal lesion
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 |
|---|---|---|
| Cyberknife Radiation TherapyStereotactic Radiotherapy of lymphnode recurrence after prostatectomy +/- salvage radiotherapy | Radiation | – |
Primary outcome
time to biochemical recurrence
Time frame: 18 months
time interval from SBRT until second PSA rise
2 secondary outcomes
biochemical response rate
Time frame: 18 months
time interval between SBRT and ADT start
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- 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. This study is not recruiting at the moment.
Daniel R Zwahlen, MD study director
Kantonsspital Graubünden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer Recurrent and Prostate Cancer, run by Kantonsspital Graubünden at 1 site in Switzerland.
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 17 Aug 2018. 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 Switzerland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to biochemical recurrence (time frame: 18 months). 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 17 Aug 2018.