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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
N/A
Open (Enrolling)
Male
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


OBJECTIVES:

Primary

- 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
cancer.

Secondary

- 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
Nomograms.

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


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 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

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

Type of Study:

Interventional

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:

No

Principal Investigator

Richard K. Valicenti, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Kimmel Cancer Center (KCC)

Authority:

United States: Federal Government

Study ID:

RTOG-0622

NCT ID:

NCT00551525

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

Name

Location

CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Kaiser Permanente Medical Center - Los AngelesLos Angeles, California  90027
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of California Davis Cancer CenterSacramento, California  95817
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Tulane Cancer Center Office of Clinical ResearchAlexandria, Louisiana  71315-3198
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
John B. Amos Cancer CenterColumbus, Georgia  31904
Billings Clinic - DowntownBillings, Montana  59107-7000
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Barberton Citizens HospitalBarberton, Ohio  44203
Arizona Oncology Services FoundationPhoenix, Arizona  85013
Radiological Associates of Sacramento Medical Group, IncorporatedSacramento, California  95815
Sentara Cancer Institute at Sentara Norfolk General HospitalNorfolk, Virginia  23507
Solano Radiation Oncology CenterVacaville, California  95687
Mercy General HospitalSacramento, California  95819
Hudner Oncology Center at Saint Anne's Hospital - Fall RiverFall River, Massachusetts  02721
Auburn Radiation OncologyAuburn, California  95603
Radiation Oncology Centers - Cameron ParkCameron Park, California  95682
Radiation Oncology Center - RosevilleRoseville, California  95661
Mercy Cancer Center at Mercy San Juan Medical CenterCarmichael, California  95608
Robinson Radiation OncologyRavenna, Ohio  44266
Coastal Cancer Center at Sentara Virginia Beach General HospitalVirginia Beach, Virginia  23454