Clinical trial NCT00551525: 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 3D-CRT or IMRT Irradiation in High-Risk, Clinically Non-Metastatic Prostate Cancer After Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
Lead sponsor: Radiation Therapy Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: NRG Oncology
First posted: 2007-10-31
Enrollment: 67
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

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 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

Primary outcomes:
measure: Proportion of Patients With PSA Response (pt) Within 12 Weeks of Samarium 153 Administration
timeFrame: Twelve weeks from the date of Samarium 153 infusion.
Secondary outcomes:
measure: Completion of Therapy
timeFrame: 90 days from the end of radiation therapy.
measure: Number of Patients With Hematologic Toxicity at 12 Weeks
timeFrame: Twelve weeks from the date of Samarium 153 infusion.
measure: Samarium 153-related Adverse Events at 12 Weeks (Percentage of Patients)
timeFrame: Twelve weeks from the date of Samarium 153 infusion
measure: Acute and Late Radiotherapy-Related Adverse Events
timeFrame: 90 days from start of radiotherapy
measure: Freedom From Progression (FFP) Rate at 2 Years
timeFrame: From randomization to 2 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Oncology Services Foundation
state: Arizona
city: Auburn
country: United States
facility: Auburn Radiation Oncology
state: California
city: Cameron Park
country: United States
facility: Radiation Oncology Centers - Cameron Park
state: California
city: Carmichael
country: United States
facility: Mercy Cancer Center at Mercy San Juan Medical Center
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Medical Center - Los Angeles
state: California
city: Roseville
country: United States
facility: Radiation Oncology Center - Roseville
state: California
city: Sacramento
country: United States
facility: Radiological Associates of Sacramento Medical Group, Incorporated
state: California
city: Sacramento
country: United States
facility: University of California Davis Cancer Center
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Vacaville
country: United States
facility: Solano Radiation Oncology Center
state: California
city: Newark
country: United States
facility: CCOP - Christiana Care Health Services
state: Delaware
city: Gainesville
country: United States
facility: University of Florida Shands Cancer Center
state: Florida
city: Columbus
country: United States
facility: John B. Amos Cancer Center
state: Georgia
city: Alexandria
country: United States
facility: Tulane Cancer Center Office of Clinical Research
state: Louisiana
city: Fall River
country: United States
facility: Hudner Oncology Center at Saint Anne's Hospital - Fall River
state: Massachusetts
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: Pascagoula
country: United States
facility: Regional Cancer Center at Singing River Hospital
state: Mississippi
city: Saint Louis
country: United States
facility: Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
state: Missouri
city: Saint Louis
country: United States
facility: David C. Pratt Cancer Center at St. John's Mercy
state: Missouri
city: Billings
country: United States
facility: Billings Clinic - Downtown
state: Montana
city: Stony Brook
country: United States
facility: Stony Brook University Cancer Center
state: New York
city: Akron
country: United States
facility: McDowell Cancer Center at Akron General Medical Center
state: Ohio
city: Akron
country: United States
facility: Summa Center for Cancer Care at Akron City Hospital
state: Ohio
city: Barberton
country: United States
facility: Barberton Citizens Hospital
state: Ohio
city: Ravenna
country: United States
facility: Robinson Radiation Oncology
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University Cancer Institute
state: Oklahoma
city: Philadelphia
country: United States
facility: Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
state: Pennsylvania
city: Norfolk
country: United States
facility: Sentara Cancer Institute at Sentara Norfolk General Hospital
state: Virginia
city: Virginia Beach
country: United States
facility: Coastal Cancer Center at Sentara Virginia Beach General Hospital
state: Virginia
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Richard K. Valicenti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dana-Farber Cancer Institute
name: Oliver Sartor, MD
role: STUDY_CHAIR
References: