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

NCT00551525 | Completed Phase 2 Results DMC

• 3 other identifiers: RTOG-0622CDR0000570622NCI-2009-01094
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 29

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.

Conditions

Prostate Cancer

Keywords

stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With PSA Response (pt) Within 12 Weeks of Samarium 153 Administration

  A PSA response for each patient is calculated by (baseline PSA-current PSA)/baseline PSA. A decline of at least 30% is considered a response. Null hypothesis (H0): Samarium 153 is not effective (pt ≤ 0.1) vs alternative hypothesis (HA): Samarium 153 is effective (pt ≥ 0.25). The sample size of 69 analyzable patients (eligible patients receiving any protocol treatment with ≥ 12 weeks follow-up from the Samarium 153 injection) was calculated based on Fleming's Multiple Testing Procedure at a significance level of 0.019 and 91% statistical power requiring 69 patients to conclude either the null or alternative hypotheses. With only 52 analyzable patients this study had only 78% power and needed at least 11 patients with a PSA response to reject H0.

  Twelve weeks from the date of Samarium 153 infusion.

Secondary Outcomes (5)

• Completion of Therapy

  90 days from the end of radiation therapy.

• Number of Patients With Hematologic Toxicity at 12 Weeks

  Twelve weeks from the date of Samarium 153 infusion.

• Samarium 153-related Adverse Events at 12 Weeks (Percentage of Patients)

  Twelve weeks from the date of Samarium 153 infusion

• Acute and Late Radiotherapy-Related Adverse Events

  90 days from start of radiotherapy

• Freedom From Progression (FFP) Rate at 2 Years

  From randomization to 2 years

Study Arms (1)

Radiotherapy + Samarium 153

EXPERIMENTAL

Samarium 153 infusion followed by radiotherapy 12 weeks later

Radiation: Radiotherapy; Drug: Samarium 153

Interventions

Radiotherapy RADIATION

3D-CRT or IMRT 64.8-70.2 Gy to the prostatic fossa begins 12 weeks (+/- 1 week) after Samarium 153 administration. Daily tumor doses of 1.8 - 2.0 Gy per day, 5 days per week x 7-8 weeks.

Also known as: 3D-CRT, IMRT, Intensity-modulated radiation therapy

Radiotherapy + Samarium 153

Samarium 153 DRUG

Samarium 153 lexidronam dose 2.0 mCi/kg by IV injection one time within 2 weeks (+/- 3days) after registration.

Also known as: Samarium sm 153 lexidronam pentasodium, Quadramet

Radiotherapy + Samarium 153

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Biopsy evidence of M1 disease
• Presence of neuroendocrine features in any prostate cancer specimen
• PATIENT CHARACTERISTICS:
• 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)
• 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)

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• NRG Oncology: collaborator

Study Sites (29)

Arizona Oncology Services Foundation

Phoenix, Arizona, 85013, United States

Location

Auburn Radiation Oncology

Auburn, California, 95603, United States

Location

Radiation Oncology Centers - Cameron Park

Cameron Park, California, 95682, United States

Location

Mercy Cancer Center at Mercy San Juan Medical Center

Carmichael, California, 95608, United States

Location

Kaiser Permanente Medical Center - Los Angeles

Los Angeles, California, 90027, United States

Location

Radiation Oncology Center - Roseville

Roseville, California, 95661, United States

Location

Radiological Associates of Sacramento Medical Group, Incorporated

Sacramento, California, 95815, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

Solano Radiation Oncology Center

Vacaville, California, 95687, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

University of Florida Shands Cancer Center

Gainesville, Florida, 32610-0232, United States

Location

John B. Amos Cancer Center

Columbus, Georgia, 31904, United States

Location

Tulane Cancer Center Office of Clinical Research

Alexandria, Louisiana, 71315-3198, United States

Location

Hudner Oncology Center at Saint Anne's Hospital - Fall River

Fall River, Massachusetts, 02721, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

Regional Cancer Center at Singing River Hospital

Pascagoula, Mississippi, 39581, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

David C. Pratt Cancer Center at St. John's Mercy

St Louis, Missouri, 63141, United States

Location

Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Stony Brook University Cancer Center

Stony Brook, New York, 11794-9446, United States

Location

McDowell Cancer Center at Akron General Medical Center

Akron, Ohio, 44307, United States

Location

Summa Center for Cancer Care at Akron City Hospital

Akron, Ohio, 44309-2090, United States

Location

Barberton Citizens Hospital

Barberton, Ohio, 44203, United States

Location

Robinson Radiation Oncology

Ravenna, Ohio, 44266, United States

Location

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Sentara Cancer Institute at Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Coastal Cancer Center at Sentara Virginia Beach General Hospital

Virginia Beach, Virginia, 23454, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy; Radiotherapy, Conformal; Radiotherapy, Intensity-Modulated; Samarium-153; samarium Sm-153 lexidronam

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Radiotherapy, Computer-Assisted

Limitations and Caveats

Comparison of freedom from progression rate at two years with Kattan Nomograms was not possible because the pretreatment data needed for the Kattan Nomograms was not collected.

Results Point of Contact

• Title: Wendy Seiferheld, M.S.
• Organization: NRG Oncology

seiferheldw@nrgoncology.org

Study Officials

• Richard K. Valicenti, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

• Oliver Sartor, MD

  Dana-Farber Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2007
• First Posted: October 31, 2007
• Study Start: April 1, 2008
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2016
• Last Updated: July 25, 2017
• Results First Posted: July 25, 2017

Record last verified: 2017-06

Locations

US (29)