Loading clinical trials...

Sorafenib in Hormone Naïve Biochemical Recurrence of Prostate Cancer | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

Sorafenib in Hormone Naïve Biochemical Recurrence of Prostate Cancer

Phase II Double Blind Randomized Placebo Controlled Study of Sorafenib in Hormone Naïve Biochemical Recurrence of Prostate Cancer

NCT00694291•Fox Chase Cancer Center

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•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:
•* 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
+12 more criteria

Exclusion Criteria

•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.
•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.
+9 more criteria

Locations (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

June 1, 2008

Primary Completion Date

June 1, 2010

Last Updated

March 6, 2015

Conditions

Prostate Cancer

Interventions

Sorafenib

DRUG

Placebo

DRUG

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

View study

RECRUITINGPHASE2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Sorafenib in Hormone Naïve Biochemical Recurrence of Prostate Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC