Hormone Refractory Prostate CancerPhase 2NCT00629525
RAD001 in Patients With Metastatic, Hormone-Refractory Prostate Cancer
A Phase 2 study testing RAD001 in people with Hormone Refractory Prostate Cancer, run by Daniel George, MD at 1 site in United States.
Trial summary
The purpose of this study is to determine the biochemical response rate (PSA) to single agent RAD001 in patients with metastatic hormone-refractory prostate cancer (HRPC). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hormone Refractory Prostate Cancer
- What is being tested?
- RAD001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Jan 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically confirmed diagnosis of adenocarcinoma of the prostate
- Clinical or radiographic evidence of metastatic disease
- ADT using LHRH agonist (eg leuprolide, goserelin) must continue on therapy. However, ketoconazole, estrogens, and all other forms of hormonal manipulation are not permitted on study.
- Evidence of disease progression on ADT as evidenced by:
- 2 consecutive PSA levels 50% or greater above the PSA nadir achieved on ADT and separated at least 1 week apart, or
- Radiographic evidence of disease progression defined by RECIST criteria and compared to prior studies on ADT.
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- A minimum of 6 weeks has elapsed off of anti-androgen therapy without withdrawal response.
- A minimum of 4 weeks from any prior radiation therapy, surgery, chemotherapy or other investigational agent
- Biopsies will not be performed if platelet counts < 75,000/ ul, PTT, PT or INR > 1.4 times control
- Patients must have normal organ and marrow function as defined below:
- hemoglobin > 9.0g/dL
- absolute neutrophil count > 1,500/μl
- platelets > 100,000/μl
- total bilirubin < 1.5 X upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) < 2.5 X ULN
- creatinine < 1.5 X ULN
- total fasting cholesterol < 350
- total triglycerides < 300
- Patients on antilipid therapy may participate in this study.
- Age > 18 years
- ECOG performance status 0 or 1
- Ability to swallow and retain oral medication
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- History of solid organ or stem cell transplantation
- Also, no current use of chronic immunosuppressive therapy is allowed
- Patients with known brain metastases (or history of brain metastases)
- History of HIV, hepatitis B, or hepatitis C infection
- Patients who have received investigational, biologic, hormonal (other than ADT), immunotherapy, or chemotherapy less than 4 weeks prior to entry on this study or have not recovered from the toxic effects of such therapy
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (requiring antifungal, antibiotic or antiviral therapy), symptomatic congestive heart failure (NYHC III or greater), unstable angina pectoris, cardiac arrhythmia (uncontrolled SVT or any VT), or psychiatric illness/social situations that would limit compliance with study requirements
- History of malabsorption syndrome, disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel that could affect absorption, distribution, metabolism or excretion of study drugs.
- Any unresolved bowel obstruction or diarrhea
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University MEdical Center
Durham, North Carolina, 27710
About this study
Official title: A Single Arm, Two Center, Phase II Study of RAD001 in Patients With Metastatic, Hormone-Refractory Prostate Cancer
The purpose of this study is to determine the biochemical response rate (PSA) to single agent RAD001 in patients with metastatic hormone-refractory prostate cancer (HRPC).
Read the detailed description
This is a single center, Phase II study of RAD001 in men with HRPC. The study design is a straight forward, two-stage design with tumor biopsies scheduled at screening and again at 4 weeks. FLT-PET scans are performed at screening and again at day 28, following initiation of treatment in the first 10 patients. Patients are assessed for adverse events every two weeks for the first month and monthly thereafter. Patients are assessed for response by PSA every 4 weeks and when applicable, for objective response every 2 months. If 4 or more responses are seen in the first 39 patients then the study will expand to 60 patients.
- Conditions
- Hormone Refractory Prostate Cancer
- Being tested
- RAD001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAD001Drug
Also called Everolimus
RAD001 at a dose of 10 mg PO daily
| Study group | Role | What they receive |
|---|---|---|
| RAD001 | Experimental | RAD001 at a dose of 10 mg PO daily Receives: Drug: RAD001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical Response Rate
Number of participants with 50% decline in serum PSA from baseline was pre-set as the primary measure of disease response.
Measured: Patients were followed for a median of 315 days
Secondary outcomes (4)
Pathologic Response
Number of participants with either a 50% or greater decrease in proliferation index or a 50% or greater increase in apoptotic index
Measured: Patients were followed for a median of 315 days
Progression Free Survival
Time in months from the start of study treatment to the date of first progression according to RECIST 1.0, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.
Measured: Patients were followed for a median of 315 days, with the last patient censored at 1309 days.
Molecular Response
Functional extent of mTOR inhibition by changes in the phosphorylation status of pS6 in prostate tumors.
Measured: Patients were followed for a median of 315 days
Clinical Response
The percentage of participants with a complete or partial response as defined by RECIST 1.0. Response Criteria are defined below:
Complete Response: Disappearance of all target lesions Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD
Measured: Patients were followed for a median of 315 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startAug 2005
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hormone Refractory 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel George, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor-investigator, Daniel George, MD, Duke University
- Investigators
- Daniel J George, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629525
- Sponsor's protocol ID
- Pro00009495
- Other IDs
- 7521
- Status last verified
- Feb 2015
- First submitted
- 27 Feb 2008
- Last updated
- 3 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Two Center, Phase II Study of RAD001 in Patients With Metastatic, Hormone-Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00629525
- Acronym / sponsor ID
- Pro00009495
- Conditions
- Hormone Refractory Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Daniel George, MDUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Aug 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 6 Mar 2008 (estimated)
- Results
- Posted 7 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the biochemical response rate (PSA) to single agent RAD001 in patients with metastatic hormone-refractory prostate cancer (HRPC).
Detailed description
This is a single center, Phase II study of RAD001 in men with HRPC. The study design is a straight forward, two-stage design with tumor biopsies scheduled at screening and again at 4 weeks. FLT-PET scans are performed at screening and again at day 28, following initiation of treatment in the first 10 patients. Patients are assessed for adverse events every two weeks for the first month and monthly thereafter. Patients are assessed for response by PSA every 4 weeks and when applicable, for objective response every 2 months. If 4 or more responses are seen in the first 39 patients then the study will expand to 60 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAD001 | Experimental | Drug: RAD001RAD001 at a dose of 10 mg PO daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Histologically confirmed diagnosis of adenocarcinoma of the prostate
- Clinical or radiographic evidence of metastatic disease
- ADT using LHRH agonist (eg leuprolide, goserelin) must continue on therapy. However, ketoconazole, estrogens, and all other forms of hormonal manipulation are not permitted on study.
- Evidence of disease progression on ADT as evidenced by:
- A minimum of 6 weeks has elapsed off of anti-androgen therapy without withdrawal response.
Key exclusion criteria (8 listed)
- History of solid organ or stem cell transplantation
- Also, no current use of chronic immunosuppressive therapy is allowed
- Patients with known brain metastases (or history of brain metastases)
- History of HIV, hepatitis B, or hepatitis C infection
- Patients who have received investigational, biologic, hormonal (other than ADT), immunotherapy, or chemotherapy less than 4 weeks prior to entry on this study or have not recovered from the toxic effects of such therapy
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 |
|---|---|---|
| RAD001Also: EverolimusRAD001 at a dose of 10 mg PO daily | Drug | RAD001 |
Primary outcome
Biochemical Response Rate
Time frame: Patients were followed for a median of 315 days
Number of participants with 50% decline in serum PSA from baseline was pre-set as the primary measure of disease response.
4 secondary outcomes
Pathologic Response
Time frame: Patients were followed for a median of 315 days
Progression Free Survival
Time frame: Patients were followed for a median of 315 days, with the last patient censored at 1309 days.
Molecular Response
Time frame: Patients were followed for a median of 315 days
Clinical Response
Time frame: Patients were followed for a median of 315 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 J George, MD principal investigator
Duke Health
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 RAD001 in people with Hormone Refractory Prostate Cancer, run by Daniel George, MD at 1 site 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 23 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 3 Mar 2015. 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 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?
Yes. Results are posted in the registry (first posted 7 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Biochemical Response Rate (time frame: Patients were followed for a median of 315 days). 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 3 Mar 2015.