Prostate Biomarker Study
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 35 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2007 |
| End Date: | May 2011 |
Multi-Institutional Inter-SPORE Prostate Biomarker Study
Radical Prostatectomy (removal of the prostate) or radiation therapy provide excellent
outcomes for patients with localized (confined to one area) disease, yet there is still no
effective treatment once the disease has spread beyond the prostate gland. Typically, a
serum PSA test is done to diagnose prostate cancer. Following diagnosis, a prostate biopsy
and other tests help to classify the patient's disease according to the likelihood of a
recurrence. However, these assessments are imperfect. There is a need to identify and
evaluate prostate biomarkers that will provide exact information regarding the likelihood of
a recurrence (prediction) of prostate cancer.
outcomes for patients with localized (confined to one area) disease, yet there is still no
effective treatment once the disease has spread beyond the prostate gland. Typically, a
serum PSA test is done to diagnose prostate cancer. Following diagnosis, a prostate biopsy
and other tests help to classify the patient's disease according to the likelihood of a
recurrence. However, these assessments are imperfect. There is a need to identify and
evaluate prostate biomarkers that will provide exact information regarding the likelihood of
a recurrence (prediction) of prostate cancer.
The Inter-SPORE Prostate Biomarkers Study (IPBS) was established to prospectively collect
and analyze biological specimens to predict and validate outcomes after treatment for
prostate cancer. The study population will consist of patients scheduled to receive standard
of care therapy for localized prostate cancer, either radical prostatectomy (RP) or
radiation therapy (XRT; includes external beam radiation, brachytherapy, or both). Seven
hundred (700) patients (350 RP, 350 XRT) will be recruited from 11 SPORE sites over a
two-year interval. We will collect serum, plasma, lymphocytes, and prostate tissue samples
for distribution to collaborating biomarker validation sites at other prostate SPOREs, along
with clinical and epidemiologic data.
and analyze biological specimens to predict and validate outcomes after treatment for
prostate cancer. The study population will consist of patients scheduled to receive standard
of care therapy for localized prostate cancer, either radical prostatectomy (RP) or
radiation therapy (XRT; includes external beam radiation, brachytherapy, or both). Seven
hundred (700) patients (350 RP, 350 XRT) will be recruited from 11 SPORE sites over a
two-year interval. We will collect serum, plasma, lymphocytes, and prostate tissue samples
for distribution to collaborating biomarker validation sites at other prostate SPOREs, along
with clinical and epidemiologic data.
Inclusion Criteria:
- Males, 35 years of age or older, with histologically confirmed prostate
adenocarcinoma, that is clinically localized to the prostate gland.
- Biopsy performed at the SPORE institution.
- No prior therapy for prostate cancer (patients who receive neoadjuvant therapy after
collection of blood and biopsy samples are eligible).
- The patient should have 2 or more cores involved with carcinoma. The minimum amount
of tumor submitted should be 5 mm, or at least 40% of the core involved with tumor.
(This amount can be made up from 2 positive cores if 1 core is insufficient).
- Patients with clinical stage T1-T2a NXM0 prostate cancer who elect to be treated with
RP or XRT (includes external beam radiation, brachytherapy, or both) at the SPORE
institution.
- Patients with a nomogram predicted 5-year probability of freedom from biochemical
recurrence (Kattan 1998) of less than or equal to 85% (patients with intermediate
risk of recurrence).
- Ability and willingness to sign informed consent
Exclusion Criteria:
- Participation in a therapeutic clinical trial with an experimental agent.
- Previous cancer of any kind except non-melanoma skin cancer
- Previous surgical or minimally invasive treatment for enlarged prostate (e.g. TURP,
TUNA, TUIP, laser, microwave)
- Use of anti-androgen drugs during the 6 months prior to diagnosis
- Use of 5-alpha-reductase inhibitors during the 6 months prior to diagnosis
We found this trial at
2
sites
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
Click here to add this to my saved trials
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
Click here to add this to my saved trials