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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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00551525
First received: October 30, 2007
Last updated: March 3, 2014
Last verified: March 2014

October 30, 2007
March 3, 2014
April 2008
November 2015   (final data collection date for primary outcome measure)
The effectiveness of Samarium 153 [ Time Frame: Twelve weeks fro the date of Samarium 153 infusion. ] [ Designated as safety issue: No ]
Disease response
Complete list of historical versions of study NCT00551525 on ClinicalTrials.gov Archive Site
  • Completion of therapy [ Time Frame: At least 90 days of follow-up from the end of radiation therapy. ] [ Designated as safety issue: No ]
  • Hematologic toxicity at 12 weeks [ Time Frame: Twelve weeks from the date of Samarium 153 infusion. ] [ Designated as safety issue: Yes ]
  • Samarium Sm 153 lexidronam pentasodium-related adverse events at 12 weeks [ Time Frame: Twelve weeks from the date of Samarium 153 infusion. ] [ Designated as safety issue: Yes ]
  • Acute radiotherapy-related adverse events [ Time Frame: At least 90 days of follow-up from the end of radiation therapy. ] [ Designated as safety issue: Yes ]
  • Compare the freedom from progression rate at 2 years with that predicted by the Kattan Nomograms [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Completion of therapy
  • Hematologic toxicity at 12 weeks
  • Samarium Sm 153 lexidronam pentasodium-related adverse events at 12 weeks
  • Acute and late radiotherapy-related adverse events at 24 weeks
  • Compare the freedom from progression rate at 2 years with that predicted by the Kattan Nomograms
Not Provided
Not Provided
 
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
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

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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Radiation: 3-dimensional conformal radiation therapy (3D-CRT)
  • Radiation: intensity-modulated radiation therapy (IMRT)
  • Radiation: samarium Sm 153 lexidronam pentasodium
Experimental: Samarium 153 followed by 3D-CRT or IMRT
Interventions:
  • Radiation: 3-dimensional conformal radiation therapy (3D-CRT)
  • Radiation: intensity-modulated radiation therapy (IMRT)
  • Radiation: samarium Sm 153 lexidronam pentasodium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
76
Not Provided
November 2015   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00551525
RTOG-0622, CDR0000570622, NCI-2009-01094
Yes
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Richard K. Valicenti, MD Kimmel Cancer Center (KCC)
Study Chair: Oliver Sartor, MD Dana-Farber Cancer Institute
Radiation Therapy Oncology Group
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP