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Phase 3 N=165 Randomized Treatment

FACBC Outcomes for Post Prostatectomy

Prostate Cancer

Enrolled (actual)
165
Serious AEs
7.9%
Results posted
Aug 2023
Primary outcome: Primary: Failure-free Survival — 75.5; 63.0 Percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
FACBC (Drug); Radiation therapy (Radiation)
Age
Adult, Older Adult · 18+ yrs
Sex
Male
Sponsor
Emory University
Primary completion
Apr 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Failure-free Survival
75.5; 63.0
SECONDARY
Decision Changes Regarding Radiotherapy Versus no Radiotherapy
4
SECONDARY
Decision Changes Regarding Whole-pelvis Versus Local Fields
24
SECONDARY
Total Number of Decision Changes
28
SECONDARY
Prostate Bed Clinical Target Volume (CTV)
134.14; 137.18; 135.61
SECONDARY
Prostate Bed Planning Target Volume (PTV)
324.50; 327.71; 329.54
SECONDARY
PTV Dosimetric Endpoints
96.98; 96.36; 96.62; 2.60; 0.42; 1.09
SECONDARY
Rectum Dosimetric Endpoints
45.01; 45.03; 45.07; 18.35; 19.31; 18.48
SECONDARY
Bladder Dosimetric Endpoints
68.92; 68.95; 69.10; 49.68; 50.99; 50.29
SECONDARY
Rate of ≥ Grade 2 GU (Genitourinary [Renal or Urinary]) Toxicity
18; 21; 36; 42
SECONDARY
Rate of ≥ Grade 2 GI (Gastrointestinal) Toxicity
16; 11; 6; 10
SECONDARY
Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC) GU (Genitourinary) Domain Score
2.99; 3.50; 1.80; 2.66
SECONDARY
Expanded Prostate Cancer Index Composite (EPIC) GI (Gastrointestinal) Domain Score
1.20; 1.41
SECONDARY
Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Score
6.04; 7.37
SECONDARY
Expanded Prostate Cancer Index Composite (EPIC) Total Score
13.90; 17.02

Summary

Investigators will perform a study with 162 patients in whom there is a strong suspicion of prostate cancer that has returned to the body after having a prostatectomy. Half of these patients will have radiotherapy decision-making and delivery per the usual routine, and half of these patients will have the radiotherapy decision and volumes guided by the FACBC test (anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (anti-3- [18F]FACBC). The major goal of the investigation is to see whether the FACBC improves the selection and the cancer control rates of post-surgery patients with a rising PSA who undergo radiotherapy.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01666808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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