Prostatic NeoplasmsPhase 2NCT01759836
Impact of Adjuvant Statin Therapy in Patients Who Underwent Radical Prostatectomy for Locally Advanced Prostate Cancer
A Phase 2 study testing Atorvastatin 20mg in people with Prostatic Neoplasms, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Biochemical recurrence develops in approximately 30-40% of men with locally advanced prostate cancer who undergo radical prostatectomy. To date, the effect of statins on prostate cancer recurrence has been investigated in several retrospective studies with inconsistent results. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Atorvastatin 20mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 364 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2012to 30 Sep 2021
- Phase
- Phase 2
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have correspond to one of the following three pathologic criteria.
- Gleason scores 8 or greater B. Positive resection margin C. pT3-T4
- Patients must have pathologically adenocarcinoma
- Patients must be enrolled within 60 days after radical prostatectomy
- Patients must be able to provide written informed consent
Who cannot join
- Patients who have received neoadjuvant androgen deprivation therapy
- Patients who have the participation of other clinical trial within the past 3 months
- Patients who have treated with statin
- Patients who have lymph node metastasis or distant metastasis
- Patients who have 10 year risk of cardiovascular disease over 10% based on NCEP ATP III guideline.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double Blind, Placebo-controlled Study Determining the Role of Adjuvant Statin Therapy in Patients Who Underwent Radical Prostatectomy for Locally Advanced Prostate Cancer
Biochemical recurrence develops in approximately 30-40% of men with locally advanced prostate cancer who undergo radical prostatectomy. To date, the effect of statins on prostate cancer recurrence has been investigated in several retrospective studies with inconsistent results. The purpose of this study is to determine the impact of statin on biochemical recurrence after radical prostatectomy for locally advanced prostate cancer.
Read the detailed description
Estimated Enrollment: 354
Study start date: October 2012
Estimated Study Completion Date: October 2015
Statin Group: Treatment with Atorvastatin 20mg daily after radical prostatectomy during 1 year.
Control Group: Treatment with Placebo daily after radical prostatectomy during 1 year.
Follow up: every 3 months for the first year. Check PSA, Total/LDL-cholesterol and Triglyceride.
Primary End Point Rate of Biochemical recurrence
Secondary End Point Clinical progression of prostate cancer Change of Total/LDL- cholesterol and Triglycerides 5 year-Biochemical recurrence free survival
- Conditions
- Prostatic Neoplasms
- Being tested
- Atorvastatin 20mg
- Keywords
- Prostatectomy, Statins
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 20mgDrug
Atorvastatin 20mg daily for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin 20mg | Experimental | Atorvastatin 20mg daily for 1 year Receives: Drug: Atorvastatin 20mg |
| Placebo | Placebo comparator | Placebo daily for 1 year Receives: Drug: Atorvastatin 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of biochemical recurrence
Measured: One year
Secondary outcomes (1)
Biochemical recurrence free survival
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startOct 2012
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-A Pharmaceutical
- Responsible party
- Principal investigator, In Gab Jeong, MD, Asan Medical Center
- Investigators
- Choung-Soo Kim, MD, Principal investigator, Department of Urology,Asan Medical Center, Seoul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759836
- Sponsor's protocol ID
- AMC-PC2012002
- Status last verified
- Jan 2022
- First submitted
- 1 Jan 2013
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jeong IG, Lim B, Yun SC, Lim JH, Hong JH, Kim CS. Adjuvant Low-dose Statin Use after Radical Prostatectomy: The PRO-STAT Randomized Clinical Trial. Clin Cancer Res. 2021 Sep 15;27(18):5004-5011. doi: 10.1158/1078-0432.CCR-21-0480. Epub 2021 May 19.
PubMed 34011557
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind, Placebo-controlled Study Determining the Role of Adjuvant Statin Therapy in Patients Who Underwent Radical Prostatectomy for Locally Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT01759836
- Acronym / sponsor ID
- AMC-PC2012002
- Conditions
- Prostatic Neoplasms
- Keywords
- Prostatectomy, Statins
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Dong-A Pharmaceutical
- Study start
- Oct 2012
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 3 Jan 2013 (estimated)
- 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.
Biochemical recurrence develops in approximately 30-40% of men with locally advanced prostate cancer who undergo radical prostatectomy. To date, the effect of statins on prostate cancer recurrence has been investigated in several retrospective studies with inconsistent results. The purpose of this study is to determine the impact of statin on biochemical recurrence after radical prostatectomy for locally advanced prostate cancer.
Detailed description
Estimated Enrollment: 354
Study start date: October 2012
Estimated Study Completion Date: October 2015
Statin Group: Treatment with Atorvastatin 20mg daily after radical prostatectomy during 1 year.
Control Group: Treatment with Placebo daily after radical prostatectomy during 1 year.
Follow up: every 3 months for the first year. Check PSA, Total/LDL-cholesterol and Triglyceride.
Primary End Point Rate of Biochemical recurrence
Secondary End Point Clinical progression of prostate cancer Change of Total/LDL- cholesterol and Triglycerides 5 year-Biochemical recurrence free survival
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin 20mg | Experimental | Drug: Atorvastatin 20mgAtorvastatin 20mg daily for 1 year |
| Placebo | Placebo comparator | Drug: Atorvastatin 20mgPlacebo daily for 1 year |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must have correspond to one of the following three pathologic criteria.
- Patients must have pathologically adenocarcinoma
- Patients must be enrolled within 60 days after radical prostatectomy
- Patients must be able to provide written informed consent
Key exclusion criteria (5 listed)
- Patients who have received neoadjuvant androgen deprivation therapy
- Patients who have the participation of other clinical trial within the past 3 months
- Patients who have treated with statin
- Patients who have lymph node metastasis or distant metastasis
- Patients who have 10 year risk of cardiovascular disease over 10% based on NCEP ATP III guideline.
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 |
|---|---|---|
| Atorvastatin 20mgAtorvastatin 20mg daily for 1 year | Drug | Atorvastatin 20mg, Placebo |
Primary outcome
Rate of biochemical recurrence
Time frame: One year
1 secondary outcome
Biochemical recurrence free survival
Time frame: Five years
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 25 Jan 2022.
- Background: PubMed 34011557Jeong IG, Lim B, Yun SC, Lim JH, Hong JH, Kim CS. Adjuvant Low-dose Statin Use after Radical Prostatectomy: The PRO-STAT Randomized Clinical Trial. Clin Cancer Res. 2021 Sep 15;27(18):5004-5011. doi: 10.1158/1078-0432.CCR-21-0480. Epub 2021 May 19.
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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.
Choung-Soo Kim, MD principal investigator
Department of Urology,Asan Medical Center, Seoul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin 20mg in people with Prostatic Neoplasms, run by Asan Medical Center at 1 site in South Korea.
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 5 inclusion and 5 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 25 Jan 2022. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
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?
Rate of biochemical recurrence (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01759836, which also lists 1 linked publication.
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 25 Jan 2022.