Prostate CancerCAPS2NCT01763944
Carbohydrate Restriction and Prostate Cancer Growth
A study testing Low carbohydrate diet in people with Prostate Cancer, run by Duke University at 3 sites in United States.
Trial summary
No treatments have been shown to slow prostate cancer progression after radical prostatectomy. We hypothesize that a carbohydrate restricted diet will slow prostate cancer growth. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Low carbohydrate diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Dec 2013to 20 Aug 2018
- Phase
- Interventional
- 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 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Received prior radical prostatectomy or definitive local radiation for prostate cancer (either external beam radiation, brachytherapy, or combination)
- PSA within the past 3 months is between 0.4 and 20 if prior radical prostatectomy, or between 3 and 20 ng/ml if prior radiation therapy.
- PSA doubling time (PSADT) >3 months and <36 months
- Calculated based at least 2 values (at least 0.2) in the prior 2 years with the first and last PSA separated by at least 3 months
- Use all values in the last 2 years to calculate PSADT
- PSADT calculated while NOT on androgen deprivation therapy (ADT).
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- If prior ADT use, then documented either A) normal testosterone or B) a testosterone within 50 points of normal and stable (defined as a second testosterone at least 6 weeks later that is equal or lower than the first testosterone) is required before starting to calculate PSADT.
- BMI >=24 kg/m2
- Willing to be randomized to a no-diet control or a low-carbohydrate diet
- Reads, writes, and understands English
Who cannot join
- Anticipate needing secondary prostate cancer therapy within the next 6 months (i.e. radiation, or hormonal therapy)
- Current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program
- Currently on therapy aimed at lowering testosterone levels (includes gonadotropin-releasing hormone (GnRH) agonist/antagonist, prior bilateral orchiectomy, oral anti-androgens, or 5-alpha reductase inhibitors). Testosterone replacement is allowed but treatment should be stable during the entire study.
- Known distant metastatic disease
- Already consuming a carbohydrate-restricted or vegetarian diet
- Unable or unwilling to adhere to a carbohydrate-restricted dietary intervention
- Weight loss >5% of body weight in the last 6 months
- Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Duke University Medical Center
Durham, North Carolina, 27702
Durham VA Medical Center
Durham, North Carolina, 27705
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men With A Rising PSA After Failed Primary Therapy for Prostate Cancer
No treatments have been shown to slow prostate cancer progression after radical prostatectomy. We hypothesize that a carbohydrate restricted diet will slow prostate cancer growth. A total of 60 men with a rising prostate-specific antigen (PSA) after failed primary treatment will be recruited and randomized to either a low-carbohydrate diet (<20 grams carbohydrates/day) or a no-diet control (standard of care) for 6 months. The primary outcome is PSA doubling time.
- Conditions
- Prostate Cancer
- Being tested
- Low carbohydrate diet
- Keywords
- diet, prostate cancer, carbohydrate, lifestyle
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low carbohydrate dietBehavioural
The Low carbohydrate diet intervention recommends patients to limit carbohydrate intake to less than 20 gram per day.
| Study group | Role | What they receive |
|---|---|---|
| Low carbohydrate, lifestyle counseling | Active comparator | The Low carbohydrate arm will receive counseling to follow a carbohydrate restriction diet (<20 grams per day) for 6 months. Receives: Behavioral: Low carbohydrate diet |
| Control | No intervention | The control arm will receive no dietary intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA doubling time (change in PSA over time)
PSA doubling time will be estimated from PSA measured at baseline, 3 and 6 months post randomization.
Measured: Baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study start16 Dec 2013
- Primary completion20 Aug 2018
- Study completion20 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), Robert C. Atkins Foundation, Cedars-Sinai Medical Center, Durham VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Pao-Hwa Lin, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763944
- Sponsor's protocol ID
- Pro00041857
- Other IDs
- 1K24CA160653-01A1, 192822
- Acronym
- CAPS2
- Status last verified
- Oct 2018
- First submitted
- 14 Dec 2012
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Lin PH, Howard L, Freedland SJ. Weight loss via a low-carbohydrate diet improved the intestinal permeability marker, zonulin, in prostate cancer patients. Ann Med. 2022 Dec;54(1):1221-1225. doi: 10.1080/07853890.2022.2069853.
PubMed 35486445Lin PH, Howard L, Freedland SJ. Impact of Low Carbohydrate Diet on Self-Report Fatigue and Weakness in Prostate Cancer Patients. J Urol. 2021 Sep;206(3):499-501. doi: 10.1097/JU.0000000000001780. Epub 2021 Apr 5. No abstract available.
PubMed 33819069Freedland SJ, Allen J, Jarman A, Oyekunle T, Armstrong AJ, Moul JW, Sandler HM, Posadas E, Levin D, Wiggins E, Howard LE, Wu Y, Lin PH. A Randomized Controlled Trial of a 6-Month Low-Carbohydrate Intervention on Disease Progression in Men with Recurrent Prostate Cancer: Carbohydrate and Prostate Study 2 (CAPS2). Clin Cancer Res. 2020 Jun 15;26(12):3035-3043. doi: 10.1158/1078-0432.CCR-19-3873. Epub 2020 Feb 27.
PubMed 32108029
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men With A Rising PSA After Failed Primary Therapy for Prostate Cancer
- ClinicalTrials.gov ID
- NCT01763944
- Acronym / sponsor ID
- CAPS2 / Pro00041857
- Conditions
- Prostate Cancer
- Keywords
- diet, prostate cancer, carbohydrate, lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), Robert C. Atkins Foundation, Cedars-Sinai Medical Center, Durham VA Medical Center
- Study start
- 16 Dec 2013 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 9 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.
No treatments have been shown to slow prostate cancer progression after radical prostatectomy. We hypothesize that a carbohydrate restricted diet will slow prostate cancer growth. A total of 60 men with a rising prostate-specific antigen (PSA) after failed primary treatment will be recruited and randomized to either a low-carbohydrate diet (<20 grams carbohydrates/day) or a no-diet control (standard of care) for 6 months. The primary outcome is PSA doubling time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low carbohydrate, lifestyle counseling | Active comparator | Behavioral: Low carbohydrate dietThe Low carbohydrate arm will receive counseling to follow a carbohydrate restriction diet (<20 grams per day) for 6 months. |
| Control | No intervention | –The control arm will receive no dietary intervention. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Received prior radical prostatectomy or definitive local radiation for prostate cancer (either external beam radiation, brachytherapy, or combination)
- PSA within the past 3 months is between 0.4 and 20 if prior radical prostatectomy, or between 3 and 20 ng/ml if prior radiation therapy.
- PSA doubling time (PSADT) >3 months and <36 months
- BMI >=24 kg/m2
- Willing to be randomized to a no-diet control or a low-carbohydrate diet
Key exclusion criteria (8 listed)
- Anticipate needing secondary prostate cancer therapy within the next 6 months (i.e. radiation, or hormonal therapy)
- Current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program
- Currently on therapy aimed at lowering testosterone levels (includes gonadotropin-releasing hormone (GnRH) agonist/antagonist, prior bilateral orchiectomy, oral anti-androgens, or 5-alpha reductase inhibitors). Testosterone replacement is allowed but treatment should be stable during the entire study.
- Known distant metastatic disease
- Already consuming a carbohydrate-restricted or vegetarian diet
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 |
|---|---|---|
| Low carbohydrate dietThe Low carbohydrate diet intervention recommends patients to limit carbohydrate intake to less than 20 gram per day. | Behavioural | Low carbohydrate, lifestyle counseling |
Primary outcome
PSA doubling time (change in PSA over time)
Time frame: Baseline, 3 and 6 months
PSA doubling time will be estimated from PSA measured at baseline, 3 and 6 months post randomization.
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 12 Oct 2018.
- Derived from this study: PubMed 35486445Lin PH, Howard L, Freedland SJ. Weight loss via a low-carbohydrate diet improved the intestinal permeability marker, zonulin, in prostate cancer patients. Ann Med. 2022 Dec;54(1):1221-1225. doi: 10.1080/07853890.2022.2069853.
- Derived from this study: PubMed 33819069Lin PH, Howard L, Freedland SJ. Impact of Low Carbohydrate Diet on Self-Report Fatigue and Weakness in Prostate Cancer Patients. J Urol. 2021 Sep;206(3):499-501. doi: 10.1097/JU.0000000000001780. Epub 2021 Apr 5. No abstract available.
- Derived from this study: PubMed 32108029Freedland SJ, Allen J, Jarman A, Oyekunle T, Armstrong AJ, Moul JW, Sandler HM, Posadas E, Levin D, Wiggins E, Howard LE, Wu Y, Lin PH. A Randomized Controlled Trial of a 6-Month Low-Carbohydrate Intervention on Disease Progression in Men with Recurrent Prostate Cancer: Carbohydrate and Prostate Study 2 (CAPS2). Clin Cancer Res. 2020 Jun 15;26(12):3035-3043. doi: 10.1158/1078-0432.CCR-19-3873. Epub 2020 Feb 27.
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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.
Pao-Hwa Lin principal investigator
Duke University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low carbohydrate diet in people with Prostate Cancer, run by Duke University at 3 sites in United States.
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 8 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 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
PSA doubling time (change in PSA over time) (time frame: Baseline, 3 and 6 months). 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 NCT01763944, which also lists 3 linked publications.
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 Oct 2018.