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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

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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

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