Image-guided adaptive stereotactic body radiation therapy for localized prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Men with localized prostate adenocarcinoma are randomized to receive either conventional MRI/CT-guided SBRT without daily plan changes or daily, real-time adaptive SBRT that adjusts the plan based on same-day imaging. The primary outcome is acute patient-reported genitourinary toxicity, with secondary outcomes including other acute toxicities, long-term quality of life, physician-scored GU and GI toxicity, and 5-year biochemical recurrence-free survival. The trial also collects biospecimens to correlate reported and observed toxicities with a commercial genetic biomarker (PROSTOX). Treatments are delivered over five fractions with imaging before each session for the adaptive arm.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18
* Histologically confirmed, clinically localized adenocarcinoma of the prostate
* Staging workup as recommended by the National Comprehensive Cancer Network (NCCN) on the basis of risk grouping

  * Advanced imaging studies (i.e. prostate-specific membrane antigen \[PSMA\] positron emission tomography \[PET\]/CT and fluciclovine PET/CT scan) can supplant a bone scan if performed first
* No evidence of metastatic disease in lymph nodes above the bifurcation of the renal arteries, or in bones or visceral organs (nodal disease identified on a PSMA PET/CT scan below the bifurcation of the renal arteries are amenable)
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* No indication for urgent or emergent radiation
* Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study

Exclusion Criteria:

* Patients with neuroendocrine or small cell carcinoma of the prostate
* Patients with any evidence of distant metastases except that evidence of lymphadenopathy below the level of the renal arteries can be deemed locoregional per the discretion of the investigator
* Prior cryosurgery, high-intensity focused ultrasound (HIFU), brachytherapy, or other ablative treatments of the whole prostate
* Prior pelvic radiotherapy
* History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data

Where it's running

• UCLA / Jonsson Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Amar W. Kishan, MD — UCLA / Jonsson Comprehensive Cancer Center
• Study coordinator: Carol W. Felix
• Email: cfelix@mednet.ucla.edu
• Phone: 310-825-9771

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adaptive radiation therapy for localized prostate cancer

  This study is testing a new type of radiation therapy for localized prostate cancer to see if it can improve patients' quality of life compared to standard treatment.

  Recruiting at 5 sites Mayo Clinic · Albert Lea, Minnesota and 4 other locations · NCT06325046

• MRI or CT planning to guide high-dose-rate prostate brachytherapy

  This trial tests whether adding an MRI to CT-based treatment planning for HDR prostate brachytherapy changes urinary side effects in men with localized prostate cancer.

  Recruiting at 3 sites Emory University · Atlanta, Georgia and 2 other locations · NCT07859722

• Exercise after pelvic radiation to see if it lowers colorectal cancer risk

  This study tests whether regular walking therapy after pelvic radiation for prostate cancer can influence markers of colorectal cancer in colon tissue and blood.

  Recruiting at 2 sites City of Hope Medical Center · Duarte, California and 1 other locations · NCT07790718

• Wrapping nerves with a multi-layer perinatal tissue graft during prostate removal

  This trial will test whether wrapping the nerves with a multi-layer perinatal tissue allograft during nerve-sparing robotic prostate removal helps men with localized prostate cancer keep erectile and urinary function.

  Recruiting Mayo Clinic · Jacksonville, Florida · NCT06940271

• Testosterone therapy for men with low testosterone and localized prostate cancer on active surveillance

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  Recruiting Phase 4 Roswell Park Cancer Institute · Buffalo, New York · NCT06733350

• Using advanced imaging to predict lymph node spread in high-risk prostate cancer

  This study is testing a new imaging method to see if it can help doctors predict whether high-risk prostate cancer has spread to lymph nodes before surgery.

  Recruiting Mayo Clinic · Jacksonville, Florida · NCT06389786

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.