Comparing shorter radiation therapy to standard radiation for high-risk 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

This phase III trial evaluates the effectiveness of stereotactic body radiation therapy (SBRT), which involves five treatments over two weeks with a higher dose per session, against the conventional radiation therapy that typically requires 20 to 45 treatments over 4 to 9 weeks. The study aims to determine if the shorter duration of SBRT can prevent cancer recurrence as effectively as the standard treatment. It also assesses various secondary outcomes, including treatment toxicity, patient-reported urinary and bowel function, fatigue, and overall survival rates. Participants will be randomized to receive either treatment to compare their outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer
* High-risk disease defined as having at least one or more of the following:

  * cT3a-T3b by digital exam or imaging (American Joint Committee on Cancer \[AJCC\] 8th edition \[Ed.\]) Note: cT4 by imaging or on digital rectal exam is not allowed
  * The patient's prostate specific antigen (PSA) value \> 20 ng/mL prior to starting androgen deprivation therapy (ADT) Note: Patients taking a 5-alpha reductase inhibitor (ex finasteride or dutasteride) are eligible The baseline PSA value should be doubled for PSAs taken while on 5-alpha reductase inhibitors
  * Gleason Score of 8-10
  * Pelvic node positive by conventional imaging with a short axis of at least 1.0 cm
* Prostate gland volume less than 100 cc prior to initiation of ADT as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including MRI or CT scan
* No definitive clinical or radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI); Negative prostate-specific membrane antigen (PSMA) positron emission tomography (PET) is an acceptable substitute
* Age \>= 18
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
* No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
* No prior radical prostatectomy
* No prior ablative or focal therapy to the prostate (including, but not limited to, transrectal or transurethral high-intensity focused ultrasound \[HIFU\], laser ablation, cryotherapy, irreversible electroporation \[IRE\], and vascular-targeted photodynamic therapy)
* Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone releasing hormone \[LHRH\] agonist and oral anti-androgen) is =\< 185 days prior to registration; Please note: PSA prior to the start of any ADT will be used to define disease
* No contraindication to prostate MRI (required for planning of radiotherapy in both arms)
* Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation therapy treatment planning and start of radiation therapy

Where it's running

• University of Alabama at Birmingham Cancer Center
  Birmingham, Alabama, United States Recruiting
• The Kirklin Clinic at Acton Road
  Birmingham, Alabama, United States Recruiting
• Lewis and Faye Manderson Cancer Center
  Tuscaloosa, Alabama, United States Recruiting
• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Recruiting
• Kaiser Permanente-Deer Valley Medical Center
  Antioch, California, United States Recruiting
• Tower Cancer Research Foundation
  Beverly Hills, California, United States Recruiting

+386 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Karen E Hoffman — NRG Oncology

Similar studies

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

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• Androgen therapy with or without niraparib for high-risk prostate cancer after radiation

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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.