Return to Results

A Phase II Trial of Samarium 153 Followed by Salvage Prostatic Fossa 3D-CRT or IMRT Irradiation in High-Risk, Clinically Non-Metastatic Prostate Cancer After Radical Prostatectomy

new search

Trial Conditions
  • Prostate Cancer
What is the purpose of this trial?

RATIONALE: Giving samarium Sm 153 lexidronam pentasodium and 3-dimensional (3-D) conformal radiation therapy or intensity-modulated radiation therapy may keep prostate cancer from growing in patients with rising prostate-specific antigen (PSA) levels after radical prostatectomy for prostate cancer. PURPOSE: This phase II trial is studying how well samarium Sm 153 lexidronam pentasodium and 3-D conformal radiation therapy or intensity-modulated radiation therapy work in treating patients with rising PSA levels after radical prostatectomy for prostate cancer.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Male

Eligibility

DISEASE CHARACTERISTICS:

Inclusion criteria:

- Histologically proven diagnosis of prostate cancer progressing after prior radical
prostatectomy as indicated by one of the following:

- Postoperative prostate-specific antigen (PSA) rising above 1.0 ng/mL

- Postoperative PSA rising above 0.2 ng/mL with a surgical tumor Gleason score of
9 or 10

- Postoperative PSA rising above 0.2 ng/ml with nodal disease

- Stage II-IV disease (T2 -T4, N0-N1)

- No distant metastases based on the following minimum diagnostic work up:

- History or physical examination within the past 8 weeks

- Bone scan negative for bone metastases within the past 4 months

- Abdominal imaging negative for metastases within the past 6 months

Exclusion criteria:

- Biopsy evidence of M1 disease

- Presence of neuroendocrine features in any prostate cancer specimen

PATIENT CHARACTERISTICS:

Inclusion criteria:

- Zubrod Performance Status 0-1

- Absolute neutrophil count (ANC) ≥ 1,800 cells/mm³

- Platelet count ≥ 100,000 cells/mm³

- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is
permitted)

Exclusion criteria:

- Prior invasive malignancy (except nonmelanoma skin cancer) unless disease free for a
minimum of 3 years

- Severe, active comorbidity, defined as follows:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the last 6 months

- Transmural myocardial infarction within the last 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics at the
time of registration

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
(laboratory tests for liver function and coagulation parameters, however, are
not required for entry into this protocol)

- Renal failure (laboratory tests for renal function, however, are not required
for entry into this protocol)

- AIDS based upon current Centers for Disease Control (CDC) definition (HIV
testing is not required)

PRIOR CONCURRENT THERAPY:

- No prior systemic chemotherapy for the study cancer

- Prior chemotherapy for a different cancer is permitted

- No hormonal therapy initiated within the last 3 months

- No prior radiotherapy to the pelvic region that would result in overlap of
radiotherapy fields

Gender: Male
Steward Physician(s)
  • Richard K. Valicenti, MD
  • Oliver Sartor, MD
Facilities
  • Saint Anne's Hospital - Active, not recruiting
Trial Interventions
Radiation
  • 3-dimensional conformal radiation therapy (3D-CRT)
  • intensity-modulated radiation therapy (IMRT)
  • samarium Sm 153 lexidronam pentasodium
Physician Researcher

Investigator Name:

  • Richard K. Valicenti, MD
  • Oliver Sartor, MD

Other Information

Sponsor: Radiation Therapy Oncology Group
Phase: Phase 2
Trial ID: NCT00551525
Volunteers:  Not Accepting Healthy Volunteers

new search

Connect with Steward

Visit Our Twitter Feed Visit Our Facebook Page Email This Page Share This Page Print This Page

Subscribe to Believe

Our electronic health news
Copyright © 2014 Steward Health Care
Connect Healthcare Panacea CMS Solutions