RecruitingPhase 3

Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer

The Phase III 'High Five Trial' Five Fraction Radiation For High-Risk Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 weeks, 5 years
  • Procedures mentioned: Questionnaires, MRI scans, CT scans, Urine samples

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer."
  • "To compare patient-reported quality of life (assessed by European Quality of Life Five Dimension Five Level Scale Questionnaire \[EQ-5D-5L\]) between treatment arms."
  • "ARM I: Patients undergo SBRT for a total of 5 treatments over 2 weeks in the absence of disease progression or unacceptable toxicity."
  • "Patients also undergo bone scan and/or computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)/CT during screening and CT and/or MRI on study."
  • "Additionally, patients may optionally undergo blood and urine sample collection on study."
  • "Patients also undergo bone scan and/or CT, MRI, or PET/CT during screening and CT and/or MRI on study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults with high-risk prostate cancer. It compares 5 precise radiation treatments over 2 weeks with the usual 20 to 45 treatments over 4 to 9 weeks. It tests whether the shorter treatment keeps cancer from coming back as well as the usual treatment.

This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be age 18 or older.
  • A tissue or cell test must confirm prostate adenocarcinoma, a type of prostate cancer.
  • Your cancer must have at least one high-risk feature: stage T3a–T3b (growth beyond the prostate); a PSA blood test above 20 ng/mL before hormone treatment; a Gleason score of 8–10 (a rating of cancer cells); or cancer in pelvic lymph nodes measuring at least 1 cm across their short side on standard scans.
  • Your prostate must measure less than 100 cc before starting hormone treatment.
  • Scans must show no clear cancer spread beyond the pelvic lymph nodes. A negative PSMA PET scan, which looks for prostate cancer, may also meet this rule.
  • You must be able to care for yourself and be out of bed or a chair for at least half of your waking hours.
  • Prior hormone-blocking medicine is allowed only if it started no more than 185 days before signing up. PSA before hormone treatment is used; PSA measured while taking finasteride or dutasteride is doubled.
  • If you are in study NRG-GU009, you must join NRG-GU013 before radiation planning and treatment begin.

Who can't join

  • Your cancer is stage T4 on an exam or scan, meaning it has grown into nearby structures beyond those allowed in this study.
  • You had radiation in an area that would overlap with this study’s radiation.
  • You had surgery to remove your prostate.
  • You had treatment to destroy prostate tissue, such as focused ultrasound, laser, freezing, electrical pulses, or light-based treatment.
  • You cannot safely have a prostate MRI scan, which is needed to plan radiation.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (424)

AL

AR

CA

CO

DC

DE

FL

GA

HI

IA

IL

IN

KS

KY

LA

MA

  • Brigham and Women's Hospital · Boston, MA 02115Site Public Contact · Study contact · 617-724-5200Paul L. Nguyen · Principal investigatorMore trials in Boston
  • Dana-Farber Cancer Institute · Boston, MA 02215Site Public Contact · Study contact · 877-442-3324Paul L. Nguyen · Principal investigatorMore trials in Boston
  • Dana-Farber/Brigham and Women's Cancer Center at Milford Regional · Milford, MA 01757Site Public Contact · Study contact · 877-332-4294Luke Peng · Principal investigatorMore trials in Milford
  • Dana-Farber/Brigham and Women's Cancer Center at South Shore · South Weymouth, MA 02190Site Public Contact · Study contact · 781-624-5000Luke Peng · Principal investigatorMore trials in South Weymouth

MD

ME

MI

MN

MO

MT

NC

ND

NE

NH

NJ

NM

NV

NY

OH

OK

OR

PA

SC

SD

TX

UT

VA

VT

WA

WI

WV