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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

Phase 2
18 Years
89 Years
Open (Enrolling)
Non-metastatic Prostate Cancer, Post Radical Prostatectomy

Thank you

Trial Information

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

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.

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

- 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

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

- 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.

Type of Study:


Study Design:

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

Principal Investigator

Marc E Shaves, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:

RTOG 0622



Start Date:

July 2007

Completion Date:

Related Keywords:

  • Non-Metastatic Prostate Cancer
  • Post Radical Prostatectomy
  • Prostatic Neoplasms



Sentara Norfolk General Hospital Norfolk, Virginia  23507