NCT04423211 · ECOG-ACRIN Cancer Research Group
Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
What this study is about
This phase III trial tests two questions by two separate comparisons of therapies. The first question is whether enhanced therapy (apalutamide in combination with abiraterone + prednisone) added to the usual treatment (prostate radiation therapy and short term androgen deprivation) is more effective compared to the usual treatment alone in patients with prostate cancer who experience biochemical recurrence (a rise in the blood level of prostate specific antigen \[PSA\] after surgical removal of the pr
View original scientific description
This phase III trial tests two questions by two separate comparisons of therapies.
Interventions
RADIATION
3-Dimensional Conformal Radiation Therapy
Undergo 3D CRT
DRUG
Apalutamide
Given PO
PROCEDURE
Computed Tomography
Undergo PET/CT
DRUG
Degarelix
Given SC
RADIATION
External Beam Radiation Therapy
Undergo EBRT
OTHER
Fluciclovine F18
Given IV
DRUG
Goserelin Acetate
Given SC
PROCEDURE
Intensity-Modulated Proton Therapy
Undergo IMPT
RADIATION
Intensity-Modulated Radiation Therapy
Undergo IMRT
DRUG
Leuprolide Acetate
Given IM
PROCEDURE
Magnetic Resonance Imaging
Undergo PET/MR
PROCEDURE
Positron Emission Tomography
Undergo PET/CT or PET/MR
OTHER
Quality-of-Life Assessment
Ancillary studies
OTHER
Questionnaire Administration
Ancillary studies
DRUG
Relugolix
Given PO
RADIATION
Stereotactic Body Radiation Therapy
Undergo SBRT
DRUG
Triptorelin
Given IM
RADIATION
Volume Modulated Arc Therapy
Undergo VMAT
Primary outcome measures
Progression-free survival (PFS)
Time frame: From randomization to radiographic progression by conventional imaging or positron emission tomography (PET), 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 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.
Quality of life (QOL)
Time frame: Up to 24 months
Descriptive statistics will be used to characterize QOL over time in each arm.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- STEP 0: REGISTRATION ELIGIBILITY CRITERIA
- Patient must be male and \>= 18 years of age.
- Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma
- Patient must have biochemical recurrence (BCR) after RP, defined as follows:
- If time to BCR, defined as time to first detectable PSA ( \> lower limit of normal for assay used) after RP, is \< 12 months, a minimum PSA level of \>= 0.2 ng/mL and a confirmatory reading of \>= 0.2 ng/mL is required, per the American Urological Association (AUA) definition (Note: patients with a persistent PSA reading of at least 0.2 ng/mL are eligible)
- If time to BCR, defined as time to first detectable PSA (\> lower limit of normal for assay used) after RP, is \>= 12 months, a minimum absolute PSA of 0.5 ng/mL is required
- If the patient has a detectable PSA (\> lower limit of normal for assay used) at any time after RP AND has an eligible baseline SOC
Where
- Anchorage, Alaska
- Fairbanks, Alaska
- Phoenix, Arizona
- Fort Smith, Arkansas
- Arroyo Grande, California
- Burbank, California
- Carmichael, California
- Corona, California
- Duarte, California
- Elk Grove, California
- Encinitas, California
- La Jolla, California
And 231 more locations — see the full list below.
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations