PSMA-PET Guided De-escalated Radiation Therapy for the Treatment of Recurrent Prostate Cancer after Radical Prostatectomy

Status: approved

This clinical trial studies the side effects of giving radiation therapy at a lower dose (de-escalated) with a focused dose to only spots seen on imaging (prostate-specific membrane antigen [PSMA]-positron emission tomography [PET] guided) and to see how well it works in treating patients with prostate cancer that has come back after a period of improvement (recurrent) after the surgical removal of the entire prostate (radical prostatectomy). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Standard radiation therapy for the treatment of recurrent prostate cancer includes giving radiation therapy to the prostate bed, often at a higher dose. This approach can lead to many side effects including urinary symptoms, bowel symptoms, tiredness, and erectile dysfunction. During PSMA-PET guided de-escalated radiation therapy, images are obtained using a PSMA-PET, which is a technique that uses a PET-sensitive drug to bind to tumor cells and locate the areas where tumors have recurred. Doctors then use these images to guide the radiation therapy and lower the dose given to the general prostate bed and give a focused dose to the areas identified on the PSMA-PET. PSMA-PET guided radiation therapy may be safe, tolerable, and/or effective in treating patients with recurrent prostate cancer after radical prostatectomy.

Inclusion Criteria

Prior biopsy proven prostate cancer for which they underwent a radical prostatectomy with curative intent
Evidence of biochemical recurrence as defined by National Comprehensive Cancer Network (NCCN): Persistent positive prostate-specific antigen (PSA) post-radical prostatectomy (RP) or an undetectable PSA after RP with a subsequent detectable PSA that increases on ≥ 2 determinations (PSA recurrence) or increases to PSA > 0.1 ng/mL
Targetable PSMA-avid lesion within the prostate bed, pelvic lymph nodes, or both and/or targetable lesion in prostate bed defined on MRI suspicious for local recurrence
If lesions are amenable for biopsy this may be attempted, but biopsy proven recurrence/persistence is not required for trial enrollment
Life expectancy greater than 5 years
Karnofsky performance status ≥ 80 or Eastern Cooperative Oncology Group performance status ≤ 2 within 14 days prior to registration
Age ≥ 30 years
Patient must be able to provide study-specific informed consent prior to study entry

Exclusion Criteria

Evidence of distant metastatic disease outside the pelvic lymph nodes (including osseous pelvic disease)
Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse
Relative or absolute contraindications to radiation therapy as determined by the treating physician. These include but are not limited to inflammatory bowel disease, connective tissue disorders (systemic lupus erythematosus, scleroderma, etc.), and genetic disorders that risk increased sensitivity to radiation therapy

PRIMARY OBJECTIVE:

I. Determine the impact of de-escalated PSMA-guided salvage radiation on grade 2+ acute toxicity (i.e., < 4 months) compared to historical controls.

SECONDARY OBJECTIVES:

I. Determine if 2-year biochemical progression-free survival with de-escalated PSMA-guided salvage radiation is comparable to historical post-salvage radiation treatment.

II. Evaluate chronic toxicity and patient-reported symptom outcomes from de-escalated PSMA-guided salvage radiation from 4 months to 2 years.

III. Evaluate 24-month local control, locoregional control, distant metastasis, and overall survival.

OUTLINE:

Within one month of initiating standard of care (SOC) androgen deprivation therapy (ADT), patients undergo de-escalated external beam radiation therapy of the pelvis for 25 daily treatment fractions per standard schedule followed by a sequential radiation boost to PET-avid disease for an additional 10-14 daily treatment fractions in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo PSMA-PET and magnetic resonance imaging (MRI) during screening, computed tomography (CT) on study, blood sample collection throughout the study, and PSMA-PET, CT, and/or MRI during follow-up. Patients may also undergo biopsy during screening.

After completion of study treatment, patients are followed up at 1 and 4 months and then every 3 months until 24 months after completion of ADT.

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PSMA-PET Guided De-escalated Radiation Therapy for the Treatment of Recurrent Prostate Cancer after Radical Prostatectomy

Inclusion Criteria

Exclusion Criteria

United States

Nebraska

Omaha

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PSMA-PET Guided De-escalated Radiation Therapy for the Treatment of Recurrent Prostate Cancer after Radical Prostatectomy

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