Know Cancer

forgot password

Multi-Institutional Inter-SPORE Prostate Biomarker Study

35 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

Multi-Institutional Inter-SPORE Prostate Biomarker Study

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.

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

- 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

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Coll & contrib bio spec to Inter-SPORE Prostate Biomarker Study men with clinical localized prostate ca sched to get standard of care therapy for localized prost ca, either radical prostatectomy, RT therapy

Outcome Time Frame:

pre-treatment and at yearly intervals during follow-up.

Safety Issue:


Principal Investigator

James Eastham, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2007

Completion Date:

May 2011

Related Keywords:

  • Prostate Cancer
  • Prostate
  • Prostatic Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
UCLA Los Angeles, California  90095