RAD4516-18: Advanced PET-CT Directed Post-Prostatectomy Radiotherapy to Enhance Prostate Cancer Outcomes

RAD4516-18: Advanced PET-CT Directed Post-Prostatectomy Radiotherapy to Enhance Prostate Cancer Outcomes

Gender
Minimum Age
Maximum Age
Adults
Physicians
Jani, Ashesh
Phases
II
Drugs
F-FACBC (260)
Disease Sites
Prostate
Locations
Winship Cancer Institute of Emory University Georgia Cancer Center for Excellence at Grady Winship at Emory Saint Joseph's Hospital
NCT ID
NCT03762759
Protocol Number
RAD4516-18
Contact
If interested in learning more about this clinical trial, please contact winshipcto@emory.edu or (404) 778-1868.

Title

RAD4516-18: Advanced PET-CT Directed Post-Prostatectomy Radiotherapy to Enhance Prostate Cancer Outcomes

Summary

Primary Objective:

-To improve the outcomes of post-prostatectomy radiotherapy prostate cancer patients via selection and treatment optimization with advanced molecular imaging with dose escalation.

Secondary Objectives:

-To establish the role of advanced molecular imaging with fluciclovine (18F) and 68Ga PSMA PET/CT in influencing post-prostatectomy radiotherapy decision-making.

-To establish the role of advanced molecular imaging with fluciclovine (18F) or 68Ga PSMA in altering radiotherapy treatment volumes.

Exploratory Objectives:

-To explore whether positive specific tissue biomarker signatures, when combined with standard risk criteria and findings from molecular imaging with fluciclovine or PSMA PET, have added value in predicting successful salvage radiotherapy outcome.

Detail

Primary Objective:

-To improve the outcomes of post-prostatectomy radiotherapy prostate cancer patients via selection and treatment optimization with advanced molecular imaging with dose escalation.

Secondary Objectives:

-To establish the role of advanced molecular imaging with fluciclovine (18F) and 68Ga PSMA PET/CT in influencing post-prostatectomy radiotherapy decision-making.

-To establish the role of advanced molecular imaging with fluciclovine (18F) or 68Ga PSMA in altering radiotherapy treatment volumes.

Exploratory Objectives:

-To explore whether positive specific tissue biomarker signatures, when combined with standard risk criteria and findings from molecular imaging with fluciclovine or PSMA PET, have added value in predicting successful salvage radiotherapy outcome.

Eligibility

Eligibility

Inclusion Criteria:

Adenocarcinoma of the prostate, post radical-prostatectomy

Detectable prostate-specific antigen (PSA)

Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2

No definitive findings for skeletal metastasis on technetium 99-m methyl diphosphonate (MDP) or F-18 PET bone scan

No definitive findings of systemic (extrapelvic) metastasis on CT and/or magnetic resonance (MR) scan of abdomen and pelvis

Willingness to undergo pelvic radiotherapy

Exclusion Criteria:

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

Inability to undergo fluciclovine or Ga-PSMA PET-CT

Definitive findings of systemic metastasis on conventional 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 Center for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (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