TRELSTAR - Testing and Diagnosis

Digital Rectal Exam (DRE)
A common way prostate cancer may be found is through a DRE. This procedure involves the doctor inserting a lubricated, gloved finger into the rectum to feel for unusual hard spots or bumps that could indicate cancer.

While it may be a little uncomfortable, this examination may not be painful and lasts only a short time.

Prostate-Specific Antigen (PSA)
The PSA is a blood test. American Cancer Society (ACS) recommends that physicians should offer it annually along with a DRE to men who are 50 years of age or older. Those at high risk, including African Americans and men with a father or brother who were diagnosed with prostate cancer before the age of 65, should start testing at 45. Men with several close relatives who had the cancer at an early age should begin testing at age 40.

PSA blood test results are reported as nanograms per milliliter (ng/mL). Normal results are under 4 ng/mL. If the level is between four and 10 ng/mL, there is one chance in four of having prostate cancer. If the results are above 10, the chances are higher.

The PSA test can also be used to help decide the types of treatment that might be helpful. It can determine if current treatment is working or if the cancer has returned following prior treatment. ACS recommends that both the DRE and PSA tests should be used in screening for prostate cancer.

Prostate Biopsy
A biopsy is the only way to determine for sure if someone has prostate cancer. During the biopsy, the physician removes cells from the gland so the laboratory can determine if cancer cells are present. This is usually performed in the doctor’s office and takes only about 15 minutes.

A core needle biopsy is most often used. In this procedure, the doctor places a small probe in the rectum. The probe emits sound waves that serve to create a picture of the prostate that is then projected on a video screen. This is called a transrectal ultrasound.

A narrow needle is inserted through the rectal wall and into the prostate gland. Small pieces of tissue from several areas are removed. The test is performed quickly, and there is usually little discomfort. The area where the procedure is being performed can also be numbed, if necessary.

Sometimes, cancer cells may only be present in a small area of the prostate, and the biopsy may miss it, causing a “false negative” reading. A repeat biopsy may be necessary.

Stages of Prostate Cancer

Indications and Usage
TRELSTAR^® Depot and TRELSTAR^® LA are indicated in the palliative treatment of advanced prostate cancer. TRELSTAR Depot or TRELSTAR LA offer an alternative treatment for prostate cancer when orchiectomy or estrogen administration are either not indicated or unacceptable to the patient.

Safety Information

The most commonly reported adverse events associated with the use of TRELSTAR^® Depot/TRELSTAR^® LA included hot flushes (58.6%/73.0%), skeletal pain (12.1%/13.2%), impotence (7.1%/2.3%), headache (5.0%/6.9%), leg pain (2.1%/5.2%), and edema in legs (0.0%/6.3%) . TRELSTAR is contraindicated in women who are or may become pregnant as well as patients who are hypersensitive to triptorelin, other LHRH agonists, or LHRH . Infrequent postmarketing reports of anaphylactic shock and angioedema have been received since 1986 (global experience) . As with all LHRH agonists, triptorelin causes an initial transient increase in testosterone levels. Patients may experience the onset or exacerbation of symptoms during this period, including bone pain, neuropathy, hematuria, spinal cord compression, or urethral or bladder outlet obstruction. Patients with metastatic vertebral lesions and/or urinary tract obstruction should be closely observed.