NCT00480623

Brief Summary

This study is designed to measure the impact of Satraplatin plus radiation therapy to the bed of the prostate in patients who have developed biochemical failure of their prostate cancer. The main objective of this study is to determine the maximum tolerated dose and dose limiting toxicity for the combination of satraplatin and radiation therapy and to determine the recommended dose for subsequent Phase II trials.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started May 2007

Shorter than P25 for phase_1 prostate-cancer

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

March 23, 2012

Status Verified

March 1, 2012

Enrollment Period

10 months

First QC Date

May 29, 2007

Last Update Submit

March 21, 2012

Conditions

Prostate Cancer

Keywords

Prostate CancerBiochemical FailureRadical Prostatectomy

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (1)

  • PSA Response, Time to PSA Response, Duration of PSA response, Secondary Biochemical Recurrence Free Survival, Time to Biochemical Recurrence, Effect of Satraplatin on Serum Testosterone Levels, Safety and Tolerability.

    PSA level will be evaluated on Day on of week 5. There will be an end of treatment visit within 30 days of the last RT-Satraplatin treatment. PSA will be drawn every 3 m for 2 years, then every 6 m until evidence of either PSA or clinical progression.

Interventions

Satraplatin plus radiation therapyDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of California San Francisco

San Francisco, California, 94143, United States

Location

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78230, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

satraplatinRadiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Howard Sandler, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2007

First Posted

May 31, 2007

Study Start

May 1, 2007

Primary Completion

March 1, 2008

Study Completion

April 1, 2008

Last Updated

March 23, 2012

Record last verified: 2012-03

Locations

US(4)