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Not yet recruitingPhase 2 / Phase 3

Whole Versus Partial Gland Boost During Prostate SBRT

Whole Versus Partial Gland Boost During Prostate SBRT (Gland Boost)

Who can join

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

Age
19 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: 5 years
  • Procedures mentioned: MRI scans

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
  • "In Arm B, patients will receive a boost to the dominant intra-prostatic lesion (DIL) identified on pre-treatment magnetic resonance imaging (MRI)."
  • "Participants will be followed for up to 5 years after completion of treatment."
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 tests two ways to give an extra radiation dose during SBRT, a type of focused radiation treatment for prostate cancer. It compares giving the extra dose to the main tumor area or to the whole prostate. It is for adults with prostate cancer and looks at side effects affecting urination and the bowels.

This phase 2/3 randomized trial evaluates whether dose escalation to the dominant intra-prostatic lesion (DIL) compared to whole gland dose escalation during prostate stereotactic body radiotherapy (SBRT) results in differences in genitourinary (GU) and gastrointestinal (GI) toxicities.

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

Eligibility

Who can join

  • Age 19 or older.
  • Have prostate adenocarcinoma, a type of prostate cancer, and are being offered SBRT to the prostate, with or without nearby parts of the semen-making glands.
  • Prostate size is less than 100 cc before starting hormone treatment that lowers male hormones, as measured at biopsy or on a scan.
  • An MRI before treatment shows an area rated PI-RADS 4 or 5, meaning cancer is likely or very likely.
  • Have a score below 16 on the IPSS/AUA survey, which measures problems with urination.

Who can't join

  • Have had treatment for prostate cancer before.
  • Were diagnosed with another solid tumor cancer in the past 5 years.
  • Have ever had cancer of the anus or rectum.
  • Have ever had bladder cancer that grew into deeper tissue.
  • Have had surgery that removed a full ring-shaped section of the rectum, such as LAR or APR.

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

Official eligibility criteria

Inclusion Criteria: 1. Adults ≥19 years of age 2. Patients with a diagnosis of prostate adenocarcinoma for which stereotactic body radiotherapy (SBRT) to the prostate ± proximal seminal vesicles is being offered 3. Prostate gland volume \<100 cc prior to initiation of androgen deprivation therapy (ADT), as reported at time of biopsy or by imaging (e.g., ultrasound, MRI, or CT) 4. PI-RADS 4 or 5 lesion seen on pre-treatment MRI 5. IPSS/AUA symptom score less than 16 Exclusion Criteria: 1. Prior treatment for prostate cancer 2. Prior solid cancer diagnosis within the last 5 years 3. Any history of anal or rectal cancer 4. Any history of invasive carcinoma of the bladder 5. History of prior circumferential resection of the rectum (such as LAR or APR)

Study sites (1)

NE