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Spots Global Cancer Trial Database for 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

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Trial Identification

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 3D-CRT or IMRT Irradiation in High-Risk, Clinically Non-Metastatic Prostate Cancer After Radical Prostatectomy

Study ID: NCT00551525

Conditions

Prostate Cancer

Study Description

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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Arizona Oncology Services Foundation, Phoenix, Arizona, United States

Auburn Radiation Oncology, Auburn, California, 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

Kaiser Permanente Medical Center - Los Angeles, Los Angeles, California, United States

Radiation Oncology Center - Roseville, Roseville, California, United States

Radiological Associates of Sacramento Medical Group, Incorporated, Sacramento, California, United States

University of California Davis Cancer Center, Sacramento, California, United States

Mercy General Hospital, Sacramento, California, United States

Solano Radiation Oncology Center, Vacaville, California, United States

CCOP - Christiana Care Health Services, Newark, Delaware, United States

University of Florida Shands Cancer Center, Gainesville, Florida, United States

John B. Amos Cancer Center, Columbus, Georgia, United States

Tulane Cancer Center Office of Clinical Research, Alexandria, Louisiana, United States

Hudner Oncology Center at Saint Anne's Hospital - Fall River, Fall River, Massachusetts, United States

West Michigan Cancer Center, Kalamazoo, Michigan, United States

Regional Cancer Center at Singing River Hospital, Pascagoula, Mississippi, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, Saint Louis, Missouri, United States

David C. Pratt Cancer Center at St. John's Mercy, Saint Louis, Missouri, United States

Billings Clinic - Downtown, Billings, Montana, United States

Stony Brook University Cancer Center, Stony Brook, New York, 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

Barberton Citizens Hospital, Barberton, Ohio, United States

Robinson Radiation Oncology, Ravenna, Ohio, United States

Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, United States

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States

Sentara Cancer Institute at Sentara Norfolk General Hospital, Norfolk, Virginia, United States

Coastal Cancer Center at Sentara Virginia Beach General Hospital, Virginia Beach, Virginia, United States

Contact Details

Name: Richard K. Valicenti, MD

Affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University

Role: PRINCIPAL_INVESTIGATOR

Name: Oliver Sartor, MD

Affiliation: Dana-Farber Cancer Institute

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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