Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging

Actively Recruiting

Phase 3

Age: 18Years +

MALE

NCT04423211

Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging

Led by ECOG-ACRIN Cancer Research Group · Updated on 2026-05-05

804

Participants Needed

303

Research Sites

638 weeks

Total Duration

AI-Summary

What this Trial 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 standard of care (prostate radiation therapy and short term androgen deprivation) is more effective compared to standard of care 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 prostate cancer). A second question tests treatment in patients with biochemical recurrence who show prostate cancer spreading outside the pelvis (metastasis) by positron emission tomography (PET) imaging. In these patients, the benefit of adding metastasis-directed radiation to enhanced therapy (apalutamide in combination with abiraterone + prednisone) is tested. Diagnostic procedures, such as PET, may help doctors look for cancer that has spread to the pelvis. Androgens are hormones that may cause the growth of prostate cancer cells. Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor cells. Metastasis-directed targeted radiation therapy uses high energy rays to kill tumor cells and shrink tumors that have spread. This trial may help doctors determine if using PET results to deliver more tailored treatment (i.e., adding apalutamide, with or without targeted radiation therapy, to standard of care treatment) works better than standard of care treatment alone in patients with biochemical recurrence of prostate cancer.

CONDITIONS

Official Title

Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging

Who Can Participate

Age: 18Years +

MALE

Eligibility Criteria

You may qualify if you...

Male patients aged 18 years or older
Must have had radical prostatectomy for confirmed prostate adenocarcinoma
Evidence of biochemical recurrence after surgery with specific PSA criteria depending on time since surgery
No clear evidence of extrapelvic metastases by conventional imaging within 26 weeks before registration
Eligible baseline PET scan done with FDA-approved tracer within 16 weeks before registration
Candidates for standard prostate bed and pelvic radiation therapy with androgen deprivation therapy
Ability to understand and sign informed consent; patients with impaired decision-making may participate with authorized representative
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Have not started androgen deprivation therapy for recurrence before baseline PET imaging
Not enrolled in another therapeutic clinical trial
Ability to lie flat and remain still for required scans and radiation planning
Meet safety guidelines for MRI if undergoing PET/MR
Hemoglobin ≥ 9.0 g/dL, leukocytes ≥ 3,000/mcL, neutrophils ≥ 1,500/mcL, and platelets ≥ 100,000/mcL within 8 weeks prior to registration
Total bilirubin less than 1.5 times normal limit (with exceptions for Gilbert's syndrome)
AST/ALT less than or equal to 2.5 times normal limit
Creatinine less than 1.5 times normal limit or creatinine clearance over 30 mL/min
HIV patients on effective treatment with undetectable viral load within 6 months
Cardiac function assessed as class I or II by symptoms or A or B by tests
No prior pelvic radiation therapy
Agree not to father children during study
English or Spanish speaking for quality-of-life assessments
Completed baseline PET scan with results known for extrapelvic metastases
For negative extrapelvic metastases, status of intrapelvic nodes known
For positive extrapelvic metastases, number of lesions known (1-5 or more)

You will not qualify if you...

History of seizures or conditions increasing seizure risk within 1 year before registration
History of inflammatory bowel disease or gastrointestinal disorders increasing radiation risk
Completed prior pelvic radiation therapy
Started androgen deprivation therapy for recurrence before baseline PET imaging
Enrollment in another therapeutic clinical trial
Unable to lie flat and still for scans and radiation treatment
Unable to meet MRI safety guidelines if PET/MR is required
Hemoglobin, leukocyte, neutrophil, platelet, bilirubin, liver enzyme, or creatinine levels outside specified limits
Cardiac function worse than class II symptoms or B by objective assessment
Non-English or non-Spanish speaking patients for quality-of-life components
Inability to provide informed consent or lack of authorized representative if decision-making capacity is impaired
Definite evidence of extrapelvic metastatic disease by conventional imaging prior to baseline PET scan
Missing or incomplete baseline PET scan or unknown extrapelvic metastases status
Unknown intrapelvic node status if extrapelvic metastases are negative
For patients with positive extrapelvic metastases, unknown number of lesions (1-5 or more)

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Trial Site Locations

Total: 303 locations

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States, 98508

Actively Recruiting

Alaska Breast Care and Surgery LLC