What is apalutamide studying for prostate cancer that has returned after surgery?

Apalutamide is being studied to see if adding it to standard radiation and hormone therapy improves outcomes for men whose prostate cancer has returned, as indicated by rising PSA levels. This trial also evaluates if targeted radiation based on PET imaging can better treat cancer that has spread outside the pelvis. The research is led by the ECOG-ACRIN Cancer Research Group.

Who may be eligible for this prostate cancer clinical trial?

Men aged 18 or older who have had prostate surgery and now show rising PSA levels indicating recurrence may be eligible. Participants must not have started hormone therapy before baseline imaging and must have no prior pelvic radiation. Good overall health and ability to complete imaging and treatments are required. Please review eligibility criteria for more details.

Is there any cost to participate in this prostate cancer clinical trial?

Study-related care, including the study drugs, imaging, radiation, and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 3

Age: 18Years +

MALE

ID04423211

Study of Apalutamide and Targeted Radiation Based on PET Imaging for Men with Recurrent Prostate Cancer After Surgery

Led by ECOG-ACRIN Cancer Research Group · Updated on 2026-06-18

804

Participants Needed

342

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating treatments for men with prostate cancer that has returned after surgery, focusing on those who experience a rise in prostate-specific antigen PSA levels, indicating biochemical recurrence. The study examines whether adding enhanced systemic therapy apalutamide combined with abiraterone and prednisone to standard care, which includes prostate radiation therapy and short-term androgen deprivation, improves outcomes. Additionally, for patients whose cancer has spread beyond the pelvis as detected by PET imaging, the study evaluates the benefit of adding metastasis-directed radiation therapy. Participants undergo baseline PETCT or PETMR scans to determine the extent of cancer spread. Based on these results, they are randomized into one of four treatment arms standard radiation with androgen deprivation, enhanced therapy including apalutamide, or enhanced therapy plus targeted radiation for metastatic disease. Treatments involve various forms of radiation therapy, androgen deprivation drugs, and oral apalutamide, administered over six months in the absence of disease progression or unacceptable side effects. Some patients may receive repeat PET scans to assess treatment response. During the study, participants have scheduled assessments including imaging, blood tests measuring PSA levels, and quality-of-life questionnaires over up to ten years. Follow-up visits occur every three months for the first two years, then less frequently up to ten years. Researchers monitor progression-free survival, overall survival, event-free survival, PSA progression, adverse events, and quality of life measures including cognitive function and fatigue. This long-term monitoring aims to determine the effectiveness of the added therapies compared to standard treatment alone.

CONDITIONS

Brief 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
Histopathologically confirmed prostate adenocarcinoma treated with radical prostatectomy
Biochemical recurrence after prostate surgery with specific PSA levels based on time since surgery
No definite evidence of extrapelvic metastases on conventional imaging within 26 weeks prior to registration
Eligible baseline PET scan using FDA-approved radiotracer within 16 weeks prior to registration
Candidate for standard post-prostatectomy radiation therapy with androgen deprivation therapy
Ability and willingness to sign informed consent; patients with impaired decision-making may participate with authorized representative
ECOG performance status 0-2
No prior androgen deprivation therapy for biochemical recurrence before baseline PET
Not enrolled in another therapeutic clinical trial
Ability to lie flat and tolerate PET scan and radiation planning
Meet institutional safety guidelines for MRI if undergoing PET/MR
Hemoglobin ≥ 9.0 g/dL, leukocytes ≥ 3,000/mcL, neutrophils ≥ 1,500/mcL, platelets ≥ 100,000/mcL within 8 weeks prior to registration
Liver function tests and creatinine within specified limits
HIV patients on effective therapy with undetectable viral load within 6 months
Cardiac function classified as NYHA class I or II or equivalent
No prior pelvic radiation therapy
Agreement to avoid fathering children during study
English or Spanish speaking for quality of life assessments
Completed baseline PET/CT or PET/MR scan with known extrapelvic metastases status prior to randomization
Known pelvic node status for PET-negative patients and number of extrapelvic lesions for PET-positive patients

You will not qualify if you...

History of seizures or conditions predisposing to seizures within 1 year prior to registration
Inflammatory bowel disease or gastrointestinal disorders increasing radiation risk
Prior pelvic radiation therapy
Started androgen deprivation therapy for biochemical recurrence before baseline PET
Enrollment in another therapeutic clinical trial
Inability to tolerate imaging or radiation procedures
Non-English or non-Spanish speaking patients for quality of life component
Cardiac function worse than NYHA class II or equivalent
Laboratory values outside specified limits
Unwillingness to avoid fathering children during study

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Study of Apalutamide and Targeted Radiation Based on PET Imaging for Men with Recurrent Prostate Cancer After Surgery

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria