Lower-dose radiation to parts of the prostate for some men with 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 2 trial uses MR-guided stereotactic body radiation therapy to deliver de-escalated doses to portions of the prostate in men with pathologically confirmed prostate adenocarcinoma. Eligible patients have grade group 1–3 disease, PSA under 20 ng/mL (with or without ADT), and MRI-defined tumors that can be clearly delineated and boosted without compromising urethral constraints. MRI within 12 months prior to randomization is required, and tumors must be clearly malignant on biopsy. The study compares partial, targeted dose delivery to the whole-prostate approach to assess whether reduced exposure decreases treatment-related side effects while maintaining tumor control.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Documentation of Disease

  o Patients must have pathologically confirmed prostate adenocarcinoma.
* Definition of Disease

  * Grade Group (GG) 1, 2, or 3.
  * PSA less than 20 ng/mL prior to starting ADT, if used.
  * Clinical stage of TX, T1 or T2 on digital rectal examination. May have up to radiological stage T3a on MRI. MRI must be performed within 12 months of randomization.
  * MRI-visible tumor(s), all having PIRADS v2.1 scores of 3, 4, or 5. Each tumor should be able to be delineated on T2 and diffusion-weighted imaging (DWI) +/- dynamic contrast-enhanced imaging (DCE).
  * Tumor nodule visible on MRI should be considered able to be boosted by treating clinician (ie meet urethral constraints while maintaining mandatory GTV coverage) and \<2.5cm in maximal dimension.
  * The MRI-defined lesion must be confirmed as malignant on biopsies (Grade group 1, 2, or 3).
  * Patients can be concurrently treated with androgen deprivation therapy (ADT) if this would be standard of care. LHRH analogues, LHRH agonists or Bicalutamide are permitted. ADT is not mandatory where this would usually be omitted. Patients needing greater than 6 months of ADT due to disease parameters should be excluded.
  * No high grade disease (GG3) occult to MRI-defined lesion. As a guide, any pathology for which you would consider surveillance (e.g. GG1, low volume GG2) is allowed outside of the MRI-defined area.
  * No contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia).
  * Prostate volume less than or equal to 90mL.
  * No evidence of nodal or distant metastatic disease.
* Prior Treatment

  o No history of previous radiation to the prostate, prostate surgery (including transurethral resection of the prostate (TURP)), or other local prostate cancer treatments.
* Age ≥ 18
* ECOG Performance Status of ≤ 2 (See Appendix I for performance status criteria)
* Required Organ Function

  * Adequate hematologic function defined as follows:

    * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
    * Platelets ≥ 100,000 cells/mm3
    * Hemoglobin ≥ 8 g/dl
  * Adequate renal function defined as follows:

    * Creatinine clearance (CrCL) of ≥30 mL/min by the Cockcroft-Gault formula:

CrCl (mL/min) = \[140 - age (years)\] x weight (kg) / 72 x creatinine (mg / dL) {x 0.85 for female patients}

* Adequate hepatic function defined as follows:

  * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled)
  * AST and ALT ≤3 x institutional ULN
* Adequate cardiac function defined as follows:

  * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.
  * To be eligible for this trial, patients should be class 2B or better (see Appendix II: New York Heart Association (NYHA) Functional Classification).

    * Comorbid Conditions
* No active infection requiring parenteral antibiotic(s).
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
* No severe GU symptoms that would preclude extreme hypofractionation per the discretion of the treating physician.
* No IPSS Score greater than 19.
* No comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up.

  * Ability of the participant to understand and the willingness to sign a written informed consent form.
  * Willing to consent to contraception during and for 1 year after treatment when applicable.
  * Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study.

Where it's running

• Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activities)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Victoria Brennan, MBBCH BAO — Memorial Sloan Kettering Cancer Center
• Study coordinator: Victoria Brennan, MBBCH BAO
• Email: brennanv@mskcc.org
• Phone: 212-639-8904

Similar studies

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

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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.