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

Non-metastatic Prostate Cancer Clinical Trial

— 0622  

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT01317043
• Other study ID #: RTOG 0622
• Status: Recruiting
• Phase: Phase 2
• First received: March 11, 2011
• Last updated: March 16, 2011
• Start date: July 2007

Study information

• Verified date: March 2011
• Source: Sentara Norfolk General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 89 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

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.
• Samarium ethylenediaminetetramethylenephosphonate

Locations

Country	Name	City	State
United States	Sentara Norfolk General Hospital	Norfolk	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Sentara Norfolk General Hospital	Radiation Therapy Oncology Group

Country where clinical trial is conducted

United States,