Title
Phase III Study of Local or Systemic Therapy INtensification DIrected in Prostate CAncer Patients with Post-ProstaTEctomy Biochemical Recurrence (INDICATE)

Description
Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE).

Objective

Progression-free survival (PFS) [ Time Frame: From randomization to radiographic progression by conventional imaging, symptomatic disease or death, whichever occurs first, assessed up to 10 years ]
The power of the PFS analysis is 85% using one-sided 0.025 level stratified logrank test. The overall type I error will be controlled using an O'Brien-Fleming boundary function


PFS prolongation in patients without positron emission tomography (PET)-evidence of extrapelvic metastases [ Time Frame: Up to 10 years ]
Will evaluate whether the addition of enhanced systemic therapy to standard of care salvage therapy could prolong PFS in this patient population. Will be an intention-to-treat analysis of all randomized patients and performed in parallel with patients with PET-evidence of extrapelvic metastases.


PFS prolongation in patients with PET-evidence of extrapelvic metastases [ Time Frame: Up to 10 years ]
Will evaluate whether the addition of metastasis-directed radiation therapy to standard of care salvage therapy and enhanced systemic therapy could prolong PFS in this patient population. Will be an intention-to-treat analysis of all randomized patients and performed in parallel without patients with PET-evidence of extrapelvic metastases.

Treatment

Radiation: 3-Dimensional Conformal Radiation Therapy

Drug: Apalutamide

Procedure: Computed Tomography

Radiation: External Beam Radiation Therapy

Radiation: Fluciclovine F18

Drug: Goserelin Acetate

Procedure: Intensity-Modulated Proton Therapy

Radiation: Intensity-Modulated Radiation Therapy

Drug: Leuprolide Acetate

Procedure: Positron Emission Tomography

Radiation: Stereotactic Body Radiation Therapy

Radiation: Volume Modulated Arc Therapy

Key Eligibility See ClinicalTrials.gov record for full eligibility criteria

Applicable Disease Sites
Prostate

Participating Institutions
Johnson Creek, UW Cancer Center; UW Health Carbone Cancer Center Rockford; UW Health Eastpark Medical Center; UW Health University Hospital; Wm. S. Middleton Memorial VA Hospital