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Clinical Trial Name - Samarium Sm 153 Lexidronam Pentasodium and 3-Dimensional Conformal Radiation Therapy or Intensity-

 
Original Study ID : CDR0000570622
Secondary ID : RTOG-0622
NCT ID : NCT00551525
Brief Title : Samarium Sm 153 Lexidronam Pentasodium and 3-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Rising Prostate-Specific Antigen Levels After Radical Prostatectomy for Prostate Cancer
Official Title : A Phase II Trial of Samarium 153 Followed by Salvage Prostatic Fossa 3DCRT or IMRT Irradiation in High-Risk, Clinically Non-Metastatic Prostate Cancer After Radical Prostatectomy
Brief Summary :

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.

Source : National Cancer Institute (NCI)
Detailed Description :

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 concurrent hormonal therapy (at the start of 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 at 3 months, 6 months, and 12 months, every 6 months for 2 years, and then annually thereafter.

Overall Status : Recruiting
Start Date : April 2008
Official Title : Phase 2
Phase : Interventional
Study Design : Treatment, Open Label
Enrollment : 76
Verification Date : May 2009
First Received Date : October 30, 2007
Trial Eligibility
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

- Rapidly rising PSA profile with a doubling time of less than 6 months

- 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

- 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 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
Minimum Age : 18 Years
Maximum Age : N/A
Healthy Volunteers : No
Facilities
Facility Name : Enloe Cancer Center at Enloe Medical Center
Status : Recruiting
City : Chico
State : California
Zip Code : 95926
Country : United States
Facility Name : CCOP - Christiana Care Health Services
Status : Recruiting
City : Newark
State : Delaware
Zip Code : 19713
Country : United States
Facility Name : Baptist Cancer Institute - Jacksonville
Status : Recruiting
City : Jacksonville
State : Florida
Zip Code : 32207
Country : United States
Facility Name : Baptist Medical Center South
Status : Recruiting
City : Jascksonville
State : Florida
Zip Code : 32258
Country : United States
Facility Name : Flagler Cancer Center
Status : Recruiting
City : Saint Augustine
State : Florida
Zip Code : 32086
Country : United States
Facility Name : Florida Cancer Center - Palatka
Status : Recruiting
City : Palatka
State : Florida
Zip Code : 32177
Country : United States
Facility Name : Integrated Community Oncology Network - Orange Park
Status : Recruiting
City : Orange Park
State : Florida
Zip Code : 32073
Country : United States
Facility Name : Integrated Community Oncology Network at Southside Cancer Center
Status : Recruiting
City : Jacksonville
State : Florida
Zip Code : 32207
Country : United States
Facility Name : Integrated Community Oncology Network
Status : Recruiting
City : Jacksonville Beach
State : Florida
Zip Code : 32250
Country : United States
Facility Name : University of Florida Shands Cancer Center
Status : Recruiting
City : Gainesville
State : Florida
Zip Code : 32610-0232
Country : United States
Facility Name : CCOP - Carle Cancer Center
Status : Recruiting
City : Urbana
State : Illinois
Zip Code : 61801
Country : United States
Facility Name : Tulane Cancer Center Office of Clinical Research
Status : Recruiting
City : Alexandria
State : Louisiana
Zip Code : 71315-3198
Country : United States
Facility Name : Hudner Oncology Center at Saint Anne's Hospital - Fall River
Status : Recruiting
City : Fall River
State : Massachusetts
Zip Code : 02721
Country : United States
Facility Name : Barberton Citizens Hospital
Status : Recruiting
City : Barberton
State : Ohio
Zip Code : 44203
Country : United States
Facility Name : Cancer Treatment Center
Status : Recruiting
City : Wooster
State : Ohio
Zip Code : 44691
Country : United States
Facility Name : Charles F. Kettering Memorial Hospital
Status : Recruiting
City : Kettering
State : Ohio
Zip Code : 45429
Country : United States
Facility Name : Middletown Regional Hospital
Status : Recruiting
City : Franklin
State : Ohio
Zip Code : 45005-1066
Country : United States
Facility Name : Summa Center for Cancer Care at Akron City Hospital
Status : Recruiting
City : Akron
State : Ohio
Zip Code : 44309-2090
Country : United States
Facility Name : Oklahoma University Cancer Institute
Status : Recruiting
City : Oklahoma City
State : Oklahoma
Zip Code : 73104
Country : United States
Facility Name : Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Status : Recruiting
City : Philadelphia
State : Pennsylvania
Zip Code : 19107-5541
Country : United States
Facility Name : Mercy Hospital Cancer Center - Scranton
Status : Recruiting
City : Scranton
State : Pennsylvania
Zip Code : 18501
Country : United States
Facility Name : Sentara Cancer Institute at Sentara Norfolk General Hospital
Status : Recruiting
City : Norfolk
State : Virginia
Zip Code : 23507
Country : United States
OutComes
Primary OutComes
Measure : Disease response
Safety issue : No
Secondary OutComes
Measure : Completion of therapy
Safety issue : No
Measure : Hematologic toxicity at 12 weeks
Safety issue : Yes
Measure : Samarium Sm 153 lexidronam pentasodium-related adverse events at 12 weeks
Safety issue : Yes
Measure : Acute and late radiotherapy-related adverse events at 24 weeks
Safety issue : Yes
Measure : Compare the freedom from progression rate at 2 years with that predicted by the Kattan Nomograms
Safety issue : No
Interventions
Type : Radiation
Name : 3-dimensional conformal radiation therapy
Type : Radiation
Name : intensity-modulated radiation therapy
Type : Radiation
Name : samarium Sm 153 lexidronam pentasodium
 
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