Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer With Rising PSA After Radical Prostatectomy

Launched by JONSSON COMPREHENSIVE CANCER CENTER · Jun 1, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to treat prostate cancer in men whose prostate-specific antigen (PSA) levels are rising after they have had surgery to remove their prostate (radical prostatectomy). The treatment being studied is a type of radiation therapy called extremely hypofractionated intensity-modulated stereotactic body radiotherapy. This method uses advanced technology to deliver targeted radiation to the cancer cells while minimizing damage to surrounding healthy tissues. The goal is to see if this approach can effectively kill more cancer cells in fewer sessions, potentially leading to fewer side effects.

To participate in the trial, men aged 18 and older must have a confirmed history of prostate cancer and meet specific criteria, such as having rising PSA levels above 0.03 ng/mL or certain adverse features found during their surgery. Participants should also be generally healthy and able to understand the study details. Throughout the trial, they can expect to receive this innovative radiation treatment and be closely monitored for its effects. This study is important because it aims to improve treatment options for patients with prostate cancer that continues to progress after surgery.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent
• * Presence of any ONE of the following:
• • Adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, OR presence of tertiary Gleason grade 5 disease)
• • Documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng/mL
• • Intermediate- or high-risk Decipher genomic classifier score
• • Identification of prostate cancer in \>= 1 lymph node at the time of prostatectomy (pN+ disease)
• • CT scan and MRI of the pelvis within 120 days prior to enrollment \[note: (a) if patient has medical contraindication to MRI, an exemption will be granted and enrollment can proceed; (b) for patients with PSA \< 1.0 ng/mL, the treatment planning CT can substitute for a diagnostic CT scan; (c) a low-field, radiation planning MRI can replace the diagnostic MRI if the patient refuses or cannot obtain a high-field MRI\]
• • Bone scan OR advanced nuclear imaging study within 120 days prior to enrollment for patients with PSA \> 1.0 ng/mL
• • Age \>= 18
• • Karnofsky performance status (KPS) \>= 70 and/or Eastern Cooperative Oncology Group (ECOG) =\< 2
• • Ability to understand, and willingness to sign, the written informed consent
• Exclusion Criteria:
• • Patients with any evidence of distant metastases. Note, evidence of lymphadenopathy below the level of the renal arteries can be deemed loco regional per the discretion of the investigator
• • Patients with neuroendocrine or small cell carcinoma of the prostate
• • Prior pelvic radiotherapy
• • History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia