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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00551525
• Other study ID #: RTOG-0622
• Secondary ID: CDR0000570622NCI
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 30, 2007
• Last updated: March 3, 2016
• Start date: April 2008

Study information

• Verified date: March 2016
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 67
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• 3-dimensional conformal radiation therapy (3D-CRT)

• intensity-modulated radiation therapy (IMRT)

• samarium Sm 153 lexidronam pentasodium

Locations

Country	Name	City	State
United States	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio
United States	Summa Center for Cancer Care at Akron City Hospital	Akron	Ohio
United States	Tulane Cancer Center Office of Clinical Research	Alexandria	Louisiana
United States	Auburn Radiation Oncology	Auburn	California
United States	Barberton Citizens Hospital	Barberton	Ohio
United States	Billings Clinic - Downtown	Billings	Montana
United States	Radiation Oncology Centers - Cameron Park	Cameron Park	California
United States	Mercy Cancer Center at Mercy San Juan Medical Center	Carmichael	California
United States	John B. Amos Cancer Center	Columbus	Georgia
United States	Hudner Oncology Center at Saint Anne's Hospital - Fall River	Fall River	Massachusetts
United States	University of Florida Shands Cancer Center	Gainesville	Florida
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Kaiser Permanente Medical Center - Los Angeles	Los Angeles	California
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	Sentara Cancer Institute at Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma
United States	Regional Cancer Center at Singing River Hospital	Pascagoula	Mississippi
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Arizona Oncology Services Foundation	Phoenix	Arizona
United States	Robinson Radiation Oncology	Ravenna	Ohio
United States	Radiation Oncology Center - Roseville	Roseville	California
United States	Mercy General Hospital	Sacramento	California
United States	Radiological Associates of Sacramento Medical Group, Incorporated	Sacramento	California
United States	University of California Davis Cancer Center	Sacramento	California
United States	David C. Pratt Cancer Center at St. John's Mercy	Saint Louis	Missouri
United States	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri
United States	Stony Brook University Cancer Center	Stony Brook	New York
United States	Solano Radiation Oncology Center	Vacaville	California
United States	Coastal Cancer Center at Sentara Virginia Beach General Hospital	Virginia Beach	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	National Cancer Institute (NCI), NRG Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effectiveness of Samarium 153		Twelve weeks fro the date of Samarium 153 infusion.	No
Secondary	Completion of therapy		At least 90 days of follow-up from the end of radiation therapy.	No
Secondary	Hematologic toxicity at 12 weeks		Twelve weeks from the date of Samarium 153 infusion.	Yes
Secondary	Samarium Sm 153 lexidronam pentasodium-related adverse events at 12 weeks		Twelve weeks from the date of Samarium 153 infusion.	Yes
Secondary	Acute radiotherapy-related adverse events		At least 90 days of follow-up from the end of radiation therapy.	Yes
Secondary	Compare the freedom from progression rate at 2 years with that predicted by the Kattan Nomograms		The first occurrence of biochemical failure by PSA >= 0.4ng/ml over the nadir PSA, clinical failure (local, regional or distant) and death from any cause within 2 years from the date of registration.	No