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A Phase I Trial of Satraplatin Plus Radiation Therapy for Prostate Cancer Patients With Biochemical Recurrence Following Radical Prostatectomy

Phase 1
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

A Phase I Trial of Satraplatin Plus Radiation Therapy for Prostate Cancer Patients With Biochemical Recurrence Following Radical Prostatectomy

****Please Note: Dr.Howard Sandler's site will be open to accrual shortly, Dr.
Sarantopoulos's site in San Antonio is open and recruiting patients.****

There were approximately 232,000 cases of prostate cancer diagnosed in the US in 2005. Most
patients present with localized disease and undergo curative therapy, either radical
prostatectomy (RP) or radiation therapy (RT). Although most men are cured after this
therapy, approximately 30,000-50,000 annually in the US will develop recurrence after RP.
For most of these patients, recurrence will be defined by biochemical recurrence (BCR), a
rise in PSA with no other documented evidence of recurrence. Patients with BCR typically
receive radiation therapy to the prostate bed. However, about 50% of these patients will
develop distant recurrence outside of the pelvis and require systemic therapy.

Satraplatin is a third generation orally administered platinum compound. Early clinical
studies demonstrated activity in tumors of the ovary and lung in addition to prostate
cancer. Satraplatin has shown activity in prostate cancer in Phase II studies and has been
evaluated in a pivotal Phase III study (The SPARC trial)as a single agent as second line

Inclusion Criteria:

- Over or equal to 18 years of age.

- ECOG performance status less than or equal to 1

- Adequate organ function.

- History of radical prostatectomy with histopathologic documentation of adenocarcinoma
of the prostate.

- PSA over or equal to 0.2 ng/ml or less than or equal to 0.4 ng/ml. This includes
patients whose PSA never becomes detectable. PSA progression must be measured by two
consecutive samples, each separated by over or equal to 7 days. The PSA values of the
two consecutive sample values must be greater than the previous (baseline) value, not
greater than each other.

Exclusion Criteria:

- Known sites of measurable prostate cancer or bone scan positive for metastatic
prostate cancer. (patients with a positive Prostascint scan will not be excluded)

- Prior therapy for prostate cancer except RP and neoadjuvant hormonal therapy. This
includes chemo, hormonal (except neoadjuvant), RT, and biologic therapy.

- Lack of physical integrity of the upper GI tract, malabsorption syndromes, or
inability to tolerate or absorb oral medications, including Crohn's disease and
ulcerative colitis.

- Other concurrent immunotherapy, RT, chemotherapy,or ancillary therapy considered
investigational (utilized for non-FDA approved indications and the context of a
research investigation)and any chemotherapy not included in the study protocol.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine maximum tolerated dose and dose limiting toxicity for the combination of Satraplatin and radiation therapy.

Outcome Time Frame:

Serum chemistry and CBC will be evaluated weekly. PSA level will be evaluated on Day on of week 5.

Principal Investigator

Howard Sandler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan


United States: Food and Drug Administration

Study ID:




Start Date:

May 2007

Completion Date:

April 2008

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Biochemical Failure
  • Radical Prostatectomy
  • Prostatic Neoplasms
  • Recurrence



Medical College of Wisconsin Milwaukee, Wisconsin  53226
University of California San Francisco San Francisco, California  941104206
The University of Texas Health Science Center at San Antonio San Antonio, Texas  78229
UT Southwestern Medical Center at Dallas Dallas, Texas  75390