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 (0622)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Sentara Norfolk General Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Radiation Therapy Oncology Group
Information provided by:
Sentara Norfolk General Hospital
ClinicalTrials.gov Identifier:
NCT01317043
First received: March 11, 2011
Last updated: March 16, 2011
Last verified: March 2011
  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.


Condition Intervention Phase
Non-metastatic Prostate Cancer
Post Radical Prostatectomy
Drug: Samarium/IMRT
Drug: Samarium ethylenediaminetetramethylenephosphonate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Sentara Norfolk General Hospital:

Estimated Enrollment: 76
Study Start Date: July 2007
Arms Assigned Interventions
Experimental: Samarium/IMRT (Intensity Modulated Radiotherapy)
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.
Drug: Samarium/IMRT
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.
Drug: Samarium ethylenediaminetetramethylenephosphonate

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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01317043

Locations
United States, Virginia
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Jessica L Loring, M.S.    757-388-4393    jlloring@sentara.com   
Sponsors and Collaborators
Sentara Norfolk General Hospital
Radiation Therapy Oncology Group
Investigators
Principal Investigator: Marc E Shaves, M.D. EVMS
  More Information

No publications provided

Responsible Party: Mark E. Shaves, MD, EVMS
ClinicalTrials.gov Identifier: NCT01317043     History of Changes
Other Study ID Numbers: RTOG 0622
Study First Received: March 11, 2011
Last Updated: March 16, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Samarium ethylenediaminetetramethylenephosphonate
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 02, 2014