Clinical Trials /

A 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

NCT01317043

Description:

The pupose of this study is to assess the effectiveness of Samarium 153 administration, as determined by a 30% decline in the PSA within 12 weeks, as compared to baseline, in a population of men with high risk, clinically non-metastatic prostate cancer after a radical prostatectomy.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title:A 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
  • 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 IDs

  • ORG STUDY ID: RTOG 0622
  • NCT ID: NCT01317043

Trial Conditions

  • Non-metastatic Prostate Cancer
  • Post Radical Prostatectomy

Trial Interventions

DrugSynonymsArms
Samarium/IMRTSamarium/IMRT (Intensity Modulated Radiotherapy)
Samarium ethylenediaminetetramethylenephosphonateSamarium/IMRT (Intensity Modulated Radiotherapy)

Trial Purpose

The pupose of this study is to assess the effectiveness of Samarium 153 administration, as determined by a 30% decline in the PSA within 12 weeks, as compared to baseline, in a population of men with high risk, clinically non-metastatic prostate cancer after a radical prostatectomy.

Detailed Description

Patients with high-risk and clinically non-metastatic cancer who have a rising PSA level after a radical prostatectomy are elgible to enter this phase II trial. Initially, patients will receive Samarium 153 2.0 mCi/kg as an IV injection by the radiation oncologist one time. Twelve weeks later toxicity and PSA response will be evaluated. Next patients will receive 3D-CRT or IMRT 64.8-70.2 Gy to the prostatic fossa. If there is no PSA response at 24 weeks, patients will begin hormonal therapy at the discretion of their physicians for a suggested 2 year period.

Trial Arms

NameTypeDescriptionInterventions
Samarium/IMRT (Intensity Modulated Radiotherapy)ExperimentalPatients with high-risk and clinically non-metastatic cancer who have a rising PSA level after a radical prostatectomy are elgible to enter this phase II trial. Initially, patients will receive Samarium 153 2.0 mCi/kg as an IV injection by the radiation oncologist one time. Twelve weeks later toxicity and PSA response will be evaluated. Next patients will receive 3D-CRT or IMRT 64.8-70.2 Gy to the prostatic fossa. If there is no PSA response at 24 weeks, patients will begin hormonal therapy at the discretion of their physicians for a suggested 2 year period.
  • Samarium/IMRT
  • Samarium ethylenediaminetetramethylenephosphonate

Eligibility Criteria

Inclusion Criteria:

Pathologically (histologically) proven diagnosis of prostate cancer progressing after radical prostatectomy as indictated by one of the following:

- Postoperative PSA rising above 2.0ng/ml; or

- Postoperative PSA rising above 0.2 ng/ml with a surgical tumor Gleason score of 9 or 10; or

- Rapidly rising PSA profile with a doubling time less than 6 months.

- PSA Doubling Time (PSADT) should be calculated via the Calculation of PSA Doubling Time page on the RTOG web site http://www.rtog.org/psadt.html

- Pathologic stage T2 - T4 N0 - N1, including no distant metastases, based upon the following minimum diagnostic workup:

- History/physical examination within 8 weeks prior to registration

- Bone scan negative for bone metastases within 4 months prior to registration

- Abdominal imaging negative for metastases within 6 mothns prior to registration

- Zubrod Performance Status 0-1

- Age greater than or equal to 18 years.

- CBC/differential and PSA obtained within 4 weeks prior to registration, with adequate bone marrow function defined as follows:

- Absolute Neutrophil Count (ANC) greater than or equal to 1,800 cells/mm³

- Platelets greater than or equal to 100,000 cells/mm³

- Hemoglobin (Hgb) greater than or equal to 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb greater than or equal to 8.0 g/dl is permitted)

- Patients must be able to provide study specific informed consent prior to study entry.

Exclusion Criteria:

- Biopsy evidence of M1 disease

- Presence of neuroendocrine features in any prostate cancer specimen

- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years

- Prior systemic chemotherapy for the study cancer (Note: Prior chemotherapy for a different cancer is permitted.)

- Hormonal therapy initiated within the last 3 months

- Prior radiotherapy to the pelvic region that would result in overlap of radiation therapy fields

- Severe, active co-morbidity, 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 (Note: Laboratory tests for liver function and coagulation parameters, however, are not required for entry into this protocol.)

- Renal failure (Note: Laboratory tests for renal function, however, are not required for entry into this protocol.)

- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition (Note: HIV testing is not required). The need to exclude patients with AIDS is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.

Maximum Eligible Age:89 Years
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:Accepts Healthy Volunteers

Primary Outcome Measures

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Secondary Outcome Measures

Trial Keywords