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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

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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



- To assess the effectiveness of samarium Sm 153 lexidronam pentasodium (as determined by
a 30% decline in the PSA level within 12 weeks) followed by either three-dimensional
conformal radiation therapy or intensity-modulated radiation therapy in patients with
rising prostate-specific antigen levels (PSA) after radical prostatectomy prostate


- To assess the proportion of patients completing protocol treatment.

- To evaluate hematological toxicity at 12 weeks.

- To evaluate samarium Sm 153 lexidronam pentasodium-related adverse events at 12 weeks.

- To evaluate the "acute" and "late" radiation therapy-related events having occurred up
to 24 weeks from the end of radiation therapy.

- To compare the freedom from progression rate at 2 years to that predicted by the Kattan

OUTLINE: Patients receive samarium Sm 153 lexidronam pentasodium (SM) IV on day 1. Patients
are closely monitored for prostate-specific antigen (PSA) level and SM-associated toxicity
for 12 weeks. After the 12 weeks, patients undergo either intensity-modulated radiation
therapy or 3-dimensional conformal radiation therapy 5 days a week for 7-8 weeks. Patients
may receive hormonal therapy (after radiation therapy) at the discretion of their physician.

Treatment continues in the absence of disease progression (defined as a PSA doubling time
less than 3 months), severe thrombocytopenia (defined as a platelet count of 25,000
cells/mm³ or less), or unacceptable toxicity.

After completion of study treatment, patients are followed up at 3 months, 6 months, and 12
months, every 6 months for 2 years, and then annually thereafter.

Inclusion Criteria


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 2.0 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


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

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)


- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The effectiveness of Samarium 153

Outcome Time Frame:

Twelve weeks fro the date of Samarium 153 infusion.

Safety Issue:


Principal Investigator

Richard K. Valicenti, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Kimmel Cancer Center (KCC)


United States: Federal Government

Study ID:




Start Date:

April 2008

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms



CCOP - Christiana Care Health Services Wilmington, Delaware  19899
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Kaiser Permanente Medical Center - Los Angeles Los Angeles, California  90027
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of California Davis Cancer Center Sacramento, California  95817
McDowell Cancer Center at Akron General Medical Center Akron, Ohio  44307
University of Florida Shands Cancer Center Gainesville, Florida  32610-0232
Stony Brook University Cancer Center Stony Brook, New York  11794-8174
David C. Pratt Cancer Center at St. John's Mercy St. Louis, Missouri  63141
Tulane Cancer Center Office of Clinical Research Alexandria, Louisiana  71315-3198
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Regional Cancer Center at Singing River Hospital Pascagoula, Mississippi  39581
John B. Amos Cancer Center Columbus, Georgia  31904
Billings Clinic - Downtown Billings, Montana  59107-7000
Summa Center for Cancer Care at Akron City Hospital Akron, Ohio  44309-2090
Barberton Citizens Hospital Barberton, Ohio  44203
Arizona Oncology Services Foundation Phoenix, Arizona  85013
Radiological Associates of Sacramento Medical Group, Incorporated Sacramento, California  95815
Sentara Cancer Institute at Sentara Norfolk General Hospital Norfolk, Virginia  23507
Solano Radiation Oncology Center Vacaville, California  95687
Mercy General Hospital Sacramento, California  95819
Hudner Oncology Center at Saint Anne's Hospital - Fall River Fall River, Massachusetts  02721
Auburn Radiation Oncology Auburn, California  95603
Radiation Oncology Centers - Cameron Park Cameron Park, California  95682
Radiation Oncology Center - Roseville Roseville, California  95661
Mercy Cancer Center at Mercy San Juan Medical Center Carmichael, California  95608
Robinson Radiation Oncology Ravenna, Ohio  44266
Coastal Cancer Center at Sentara Virginia Beach General Hospital Virginia Beach, Virginia  23454