Prostate CancerPhase 2NCT00694291
Sorafenib in Hormone Naïve Biochemical Recurrence of Prostate Cancer
A Phase 2 study testing Sorafenib in people with Prostate Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to measure the benefit of sorafenib in patients with a rising PSA after treatment with radiation therapy or surgery who are NOT receiving with androgen ablation therapy. 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?
- Sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jun 2010
- 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
- Histologically confirmed adenocarcinoma of the prostate
- Prior definitive treatment with radical prostatectomy and/or radiation therapy (external beam or brachytherapy). Patients may have received post prostatectomy radiation therapy in the adjuvant setting or for biochemical recurrence.
- Hormone sensitive prostate cancer as evidence by a serum total testosterone level within the institution's normal range £4 weeks of registration. (Patients may have received hormonal therapy in the adjuvant setting provided the last dose was ³ one year from the date of enrollment.)
- All patients must have evidence of biochemical progression as determined by 3 PSA measures. (PSA-2, PSA-1 and PSA 0) The most recent PSA value (PSA0) will serve as the baseline. All of these PSA values must be obtained at the same reference lab and the earliest (PSA-2) ≥ eight weeks prior to registration, but ≤ six months prior to enrollment.
- The most recent PSA value (PSA 0) must be drawn £ seven days of treatment and must be greater than 0.4 ng/ml (after prostatectomy) or greater than ³1.5 ng ml (after radiation therapy) at the time of registration.
- The patient must be at high risk for developing distant metastases by one of the following criteria:
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- Gleason score 8-10 on original tumor specimen or
- Prostate specific antigen doubling time (PSADT) less than nine months calculated using the following formula PSADT in days = 0.693 (t) ln( PSA-1)-ln (PSA-2)
- where t = number of days between PSA- 2 and PSA-1 PSA-1 is the most recent PSA value PSA-2 is the next most recent PSA value Ln = natural log PSADT in months = PSADT divided by 30.4
- Age > 18 years old
- ECOG Performance Status 0 or 1
- Adequate bone marrow, liver and renal function as assessed by the following:
- Hemoglobin > 9.0 g/dl
- Absolute neutrophil count (ANC) > 1,500/mm3
- Platelet count > 100,000/mm3
- Total bilirubin < 1.5 times ULN
- ALT and AST < 2.5 times the ULN
- Creatinine < 1.5 times ULN
- INR < 1.5 or a PT/PTT within normal limits in patients not on therapeutic anticoagulation. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR should be measured prior to initiation of Sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable.
- Men should agree to use adequate birth control during and for at least three months after the last administration of Sorafenib.
- Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
- Consideration must be given to definitive local therapy; patient may either refuse or not be considered a candidate.
Who cannot join
- Therapy modulating testosterone levels (such as leuteinizing-hormone releasing hormone agonists/antagonists and antiandrogens) for treatment of biochemical recurrence of prostate cancer. Treatment in the neoadjuvant setting is permissible if greater than 1 year prior to registration. Agents such as 5 alpha reductase inhibitors, ketoconazole, megestrol acetate, systemic steroids, or herbal supplements that are known to affect PSA (PC Spes, saw palmetto oil) are not permitted at any time during the period that the PSA values are being collected during screening or treatment
- Evidence of measurable or evaluable metastatic disease on chest x-ray bone scan or CT scan performed ≤ four weeks of registration.
- Patients must not have received any other investigational agents or concurrent anti cancer therapy £4 weeks from treatment.
- Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began ≤ the last 3 months) or myocardial infarction ≤ the past 6 months.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
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- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
- Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Sorafenib. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies may be undertaken in patients receiving combination antiretroviral therapy in the future
- Active clinically serious infection > CTCAE Grade 2.
- Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks ≤ the past 6 months.
- Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 £4 weeks of registration.
- Any other hemorrhage/bleeding event >CTCAE Grade 3 £ 4 weeks of registration.
- Evidence or history of bleeding diathesis or coagulopathy
- Major surgery, open biopsy or significant traumatic injury ≤ 4 weeks of registration.
- Concurrent use of cytochrome P450 enzyme inducing antiepileptic drugs (phenytoin, carbamazepine, and phenobarbital), rifampin or St Johns Wort. Patients must have discontinued these medications ³14 days from starting protocol therapy
- Known or suspected allergy to Sorafenib or any agent given in the course of this trial.
- Any condition that impairs patient's ability to swallow whole pills.
- Any malabsorption problem.
- Prior history of cancer (except basal cell or squamous cell skin cancer) ≤ the past five years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Phase II Double Blind Randomized Placebo Controlled Study of Sorafenib in Hormone Naïve Biochemical Recurrence of Prostate Cancer
The purpose of this study is to measure the benefit of sorafenib in patients with a rising PSA after treatment with radiation therapy or surgery who are NOT receiving with androgen ablation therapy.
Read the detailed description
This is a placebo controlled double blind study of sorafenib versus placebo of in patients with high risk biochemical recurrence of prostate cancer. High risk characteristics include a short PSADT (<9 months) or high Gleason score (>8), characteristics, which correspond to a higher risk of prostate cancer specific mortality in patients with biochemical recurrence following radiation therapy or radical prostatectomy.
- Conditions
- Prostate Cancer
- Being tested
- Sorafenib, Placebo
- Keywords
- Rising PSA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Also called Nexavar
400 mg orally twice daily
PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Sorafenib 400 mg orally twice daily Receives: Drug: Sorafenib |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the median PSA slope of patients with non-castrate, high risk biochemical recurrence of prostate cancer following definitive local therapy treated with Sorafenib for six months compared to those treated with placebo.
Measured: 6 months
Secondary outcomes (3)
To determine the response rate based on PSA criteria and duration of PSA response.
Measured: 6 months
To compare the time to PSA progression between the Sorafenib arm and the placebo arm.
Measured: 6 months
To document the safety and tolerability of Sorafenib in this patient population.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2010 (estimated)
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.
- More trials run by Fox Chase Cancer 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Investigators
- Yu-Ning Wong, MD MSCE, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694291
- Sponsor's protocol ID
- FCCC 07-038
- Status last verified
- Mar 2015
- First submitted
- 5 Jun 2008
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Double Blind Randomized Placebo Controlled Study of Sorafenib in Hormone Naïve Biochemical Recurrence of Prostate Cancer
- ClinicalTrials.gov ID
- NCT00694291
- Acronym / sponsor ID
- FCCC 07-038
- Conditions
- Prostate Cancer
- Keywords
- Rising PSA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Jun 2008
- Primary completion
- Jun 2010 (estimated)
- First posted
- 10 Jun 2008 (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.
The purpose of this study is to measure the benefit of sorafenib in patients with a rising PSA after treatment with radiation therapy or surgery who are NOT receiving with androgen ablation therapy.
Detailed description
This is a placebo controlled double blind study of sorafenib versus placebo of in patients with high risk biochemical recurrence of prostate cancer. High risk characteristics include a short PSADT (<9 months) or high Gleason score (>8), characteristics, which correspond to a higher risk of prostate cancer specific mortality in patients with biochemical recurrence following radiation therapy or radical prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SorafenibSorafenib 400 mg orally twice daily |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Histologically confirmed adenocarcinoma of the prostate
- Prior definitive treatment with radical prostatectomy and/or radiation therapy (external beam or brachytherapy). Patients may have received post prostatectomy radiation therapy in the adjuvant setting or for biochemical recurrence.
- Hormone sensitive prostate cancer as evidence by a serum total testosterone level within the institution's normal range £4 weeks of registration. (Patients may have received hormonal therapy in the adjuvant setting provided the last dose was ³ one year from the date of enrollment.)
- All patients must have evidence of biochemical progression as determined by 3 PSA measures. (PSA-2, PSA-1 and PSA 0) The most recent PSA value (PSA0) will serve as the baseline. All of these PSA values must be obtained at the same reference lab and the earliest (PSA-2) ≥ eight weeks prior to registration, but ≤ six months prior to enrollment.
- The most recent PSA value (PSA 0) must be drawn £ seven days of treatment and must be greater than 0.4 ng/ml (after prostatectomy) or greater than ³1.5 ng ml (after radiation therapy) at the time of registration.
Key exclusion criteria (19 listed)
- Therapy modulating testosterone levels (such as leuteinizing-hormone releasing hormone agonists/antagonists and antiandrogens) for treatment of biochemical recurrence of prostate cancer. Treatment in the neoadjuvant setting is permissible if greater than 1 year prior to registration. Agents such as 5 alpha reductase inhibitors, ketoconazole, megestrol acetate, systemic steroids, or herbal supplements that are known to affect PSA (PC Spes, saw palmetto oil) are not permitted at any time during the period that the PSA values are being collected during screening or treatment
- Evidence of measurable or evaluable metastatic disease on chest x-ray bone scan or CT scan performed ≤ four weeks of registration.
- Patients must not have received any other investigational agents or concurrent anti cancer therapy £4 weeks from treatment.
- Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began ≤ the last 3 months) or myocardial infarction ≤ the past 6 months.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic 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 |
|---|---|---|
| SorafenibAlso: Nexavar400 mg orally twice daily | Drug | 1 |
| PlaceboMatching Placebo | Drug | 2 |
Primary outcome
To compare the median PSA slope of patients with non-castrate, high risk biochemical recurrence of prostate cancer following definitive local therapy treated with Sorafenib for six months compared to those treated with placebo.
Time frame: 6 months
3 secondary outcomes
To determine the response rate based on PSA criteria and duration of PSA response.
Time frame: 6 months
To compare the time to PSA progression between the Sorafenib arm and the placebo arm.
Time frame: 6 months
To document the safety and tolerability of Sorafenib in this patient population.
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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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.
Yu-Ning Wong, MD MSCE principal investigator
Fox Chase Cancer Center
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 Sorafenib in people with Prostate Cancer, run by Fox Chase Cancer Center 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 22 inclusion and 19 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: withdrawn, as of the sponsor's last update on 6 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
To compare the median PSA slope of patients with non-castrate, high risk biochemical recurrence of prostate cancer following definitive local therapy treated with Sorafenib for six months compared to those treated with placebo. (time frame: 6 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 6 Mar 2015.