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Advanced Molecular Imaging With Anti-3-[18F]FACBC PET-CT to Improve the Selection and Outcomes of Prostate Cancer Patients Receiving Post-prostatectomy Radiotherapy


Phase 2/Phase 3
18 Years
95 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Advanced Molecular Imaging With Anti-3-[18F]FACBC PET-CT to Improve the Selection and Outcomes of Prostate Cancer Patients Receiving Post-prostatectomy Radiotherapy


Inclusion Criteria:



- Adenocarcinoma of the prostate, post radical-prostatectomy Detectable PSA

- ECOG/Zubrod Performance Status of 0-2

- Negative technetium 99-m MDP or F-18 PET bone scan for skeletal metastasis

- CT or MR scan of abdomen and pelvis which does not suggest presence of metastatic
disease outside of the pelvis

- Willingness to undergo pelvic radiotherapy.

Exclusion Criteria:

- Contraindications to radiotherapy (including active inflammatory bowel disease or
prior pelvic XRT)

- Inability to undergo anti-3-[18F]FACBC PET-CT

- Age under 18

- Metastatic disease outside of pelvis on any imaging or biopsy

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

- Severe acute co-morbidity, defined as follows:

- Unstable angina and/or congestive heart failure requiring hospitalization in the
last 3 months

- Transmural myocardial infarction within the last 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics at the
time of registration

- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of
registration

- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition;
note, however, that HIV testing is not required for entry into this protocol.
The need to exclude patients with AIDS from this protocol is necessary because
the treatments involved in this protocol may be significantly immunosuppressive.
Protocol-specific requirements may also exclude immunocompromised patients

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Failure-free Survival

Outcome Description:

Definition of failure is: serum PSA value of 0.2ng/mL or more above the postradiotherapy nadir followed by another higher value, a continued rise in the serum PSA despite radiotherapy (RT), initiation of systemic therapy after completion of RT, or clinical progression.

Outcome Time Frame:

3-Year

Safety Issue:

No

Principal Investigator

Ashesh B Jani, MD, MSEE

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University

Authority:

United States: Food and Drug Administration

Study ID:

1R01CA169188-01

NCT ID:

NCT01666808

Start Date:

September 2012

Completion Date:

June 2017

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Emory UniversityAtlanta, Georgia  30322