Prostate CancerPhase 2NCT01483586
Safety and Efficacy of Kanglaite Gelcaps in Prostate Cancer
A Phase 2 study testing kanglaite gelcap in people with Prostate Cancer, run by KangLaiTe USA at 5 sites in United States.
Trial summary
This research is being done to evaluate the safety and efficacy of the investigational Kanglaite gelcap (KLTc) on PSA in men with prostate cancer when given for twelve months. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- kanglaite gelcap
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2011to Dec 2013
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed adenocarcinoma of the prostate
- undergone definitive treatment (surgery, surgery with radiation therapy, cryotherapy, radiation therapy or brachytherapy) for the primary prostate tumor with a rising PSA
- life expectancy greater than 6 months
- has Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- use of other dietary/herbal supplements (e.g. saw palmetto, selenium, etc.) has been stable for at least 2 months prior to screening and the patient agrees not to stop or change the dose while participating in the study.
- Adequate hepatic function with serum bilirubin ≤ 1.5 times the upper institutional limits of normal, ALT and AST ≤ 2.5 times the upper institutional limits of normal
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- Adequate renal function with serum creatinine ≤ 1.5 times the upper institutional limits of normal
- Adequate hematologic function (absolute neutrophil counts ≥ 1,500 mm3 and platelets ≥ 100,000 mm3)
- All electrolytes (including potassium, sodium, and serum or ionized calcium) must be within normal limits
Who cannot join
- Patients with evidence of metastatic disease would be excluded, except for presence of positive lymph nodes from the surgical pathology. Similarly, patients with radiological evidence of lymph nodes < 2 cm that lack pathological confirmation would be eligible
- Patients with a PSA doubling time of <6months at screening would be excluded
- Patients meeting Phoenix criteria for biochemical failure (nadir + ≥2ng/mL increase in serum PSA) who wish additional conventional therapy
- Any concurrent malignancy other than adequately treated basal or squamous cell skin cancer or superficial bladder cancer
- Any psychiatric or other disorders such as dementia that would prohibit the patient from understanding or rendering informed consent or from fully complying with protocol treatment and follow-up
- Inability to swallow capsules
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- Patients with a known history of gastrointestinal disease, surgery or malabsorption that could potentially impact the absorption of the study drug
- Patients requiring the use of a feeding tube
- Receipt of prior chemotherapy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
Northwestern University
Chicago, Illinois, 60611
Duke University
Durham, North Carolina, 27710
North Shore University
Evanston, Illinois, 60201
The Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
About this study
Official title: Efficacy and Safety of Oral Kanglaite (KLTc)in Men With Prostate Cancer: Randomized, Dose-Ranging Study of the Effects of KLTc on Prostate Specific Antigen (PSA) Doubling Time Among Men With Rising PSA Levels After Definitive Local Therapy
This research is being done to evaluate the safety and efficacy of the investigational Kanglaite gelcap (KLTc) on PSA in men with prostate cancer when given for twelve months.
- Conditions
- Prostate Cancer
- Being tested
- kanglaite gelcap
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kanglaite gelcapDrug
3 KLTc gelcap capsules four times a day throughout the study (12 months). Each gelcap contains .45g KLT per capsule
Kanglaite gelcapDrug
6 KLTc gelcaps taken four times a day throughout the study (12 months). Each gelcap contains .45g KLT
| Study group | Role | What they receive |
|---|---|---|
| KLTc high dose | Experimental | 6 KLTc gelcaps taken four times a day Receives: Drug: Kanglaite gelcap |
| KLTc low dose | Experimental | 3 KLTc gelcaps taken four times a day Receives: Drug: kanglaite gelcap |
What is being measured
The primary outcome is the main question the study is designed to answer.
prostate specific antigen doubling time (PSADT)
PSADT is defined as the natural log of 2 (0.693)divided by the slope (beta- rate of change) of the relationship between the log of PSA and the time of PSA measurement using linear regression model
Measured: over 12 months on study drug
Secondary outcomes (2)
PSA objective response
a 50% or more decline in PSA level compared to baseline
Measured: over 12 months on study drug
KLTc intake compliance
actual number of capsules taken divided by the expected number of capsules taken multiplied by 100 to get a percentage of compliance
Measured: each month, up to 12 months on study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- KangLaiTe USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483586
- Sponsor's protocol ID
- C10-069
- Status last verified
- Apr 2014
- First submitted
- 28 Nov 2011
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Oral Kanglaite (KLTc)in Men With Prostate Cancer: Randomized, Dose-Ranging Study of the Effects of KLTc on Prostate Specific Antigen (PSA) Doubling Time Among Men With Rising PSA Levels After Definitive Local Therapy
- ClinicalTrials.gov ID
- NCT01483586
- Acronym / sponsor ID
- C10-069
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 90 participants (actual)
- Lead sponsor
- KangLaiTe USAIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 1 Dec 2011 (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.
This research is being done to evaluate the safety and efficacy of the investigational Kanglaite gelcap (KLTc) on PSA in men with prostate cancer when given for twelve months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KLTc high dose | Experimental | Drug: Kanglaite gelcap6 KLTc gelcaps taken four times a day |
| KLTc low dose | Experimental | Drug: kanglaite gelcap3 KLTc gelcaps taken four times a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- confirmed adenocarcinoma of the prostate
- undergone definitive treatment (surgery, surgery with radiation therapy, cryotherapy, radiation therapy or brachytherapy) for the primary prostate tumor with a rising PSA
- life expectancy greater than 6 months
- has Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- use of other dietary/herbal supplements (e.g. saw palmetto, selenium, etc.) has been stable for at least 2 months prior to screening and the patient agrees not to stop or change the dose while participating in the study.
Key exclusion criteria (9 listed)
- Patients with evidence of metastatic disease would be excluded, except for presence of positive lymph nodes from the surgical pathology. Similarly, patients with radiological evidence of lymph nodes < 2 cm that lack pathological confirmation would be eligible
- Patients with a PSA doubling time of <6months at screening would be excluded
- Patients meeting Phoenix criteria for biochemical failure (nadir + ≥2ng/mL increase in serum PSA) who wish additional conventional therapy
- Any concurrent malignancy other than adequately treated basal or squamous cell skin cancer or superficial bladder cancer
- Any psychiatric or other disorders such as dementia that would prohibit the patient from understanding or rendering informed consent or from fully complying with protocol treatment and follow-up
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 |
|---|---|---|
| kanglaite gelcap3 KLTc gelcap capsules four times a day throughout the study (12 months). Each gelcap contains .45g KLT per capsule | Drug | KLTc low dose |
| Kanglaite gelcap6 KLTc gelcaps taken four times a day throughout the study (12 months). Each gelcap contains .45g KLT | Drug | KLTc high dose |
Primary outcome
prostate specific antigen doubling time (PSADT)
Time frame: over 12 months on study drug
PSADT is defined as the natural log of 2 (0.693)divided by the slope (beta- rate of change) of the relationship between the log of PSA and the time of PSA measurement using linear regression model
2 secondary outcomes
PSA objective response
Time frame: over 12 months on study drug
KLTc intake compliance
Time frame: each month, up to 12 months on study drug
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing kanglaite gelcap in people with Prostate Cancer, run by KangLaiTe USA at 5 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 9 inclusion and 9 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: stopped early, as of the sponsor's last update on 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
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 was stopped early (reason given: Sponsor decision). Results are not available in the source record.
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?
prostate specific antigen doubling time (PSADT) (time frame: over 12 months on study drug). 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 14 Apr 2014.