RightFit
RecruitingPhase 1

Two Fraction Prostate SBRT With DIL SIB

A Phase I/Ib, Single Arm Study of Two Fraction Stereotactic Body Radiation Therapy (SBRT) With Dominant Lesion Simultaneous Integrated Boost (SIB) for the Treatment of Low to Intermediate 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

  • 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
  • "Phase I/Ib, single arm trial of Two-Fraction Stereotactic Body Radiation Therapy (SBRT) with an MRI directed, dominant intraprostatic lesion (DIL), simultaneous integrated boost (SIB) based on genomic classification in the treatment of localized prostate cancer."
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

Phase I/Ib, single arm trial of Two-Fraction Stereotactic Body Radiation Therapy (SBRT) with an MRI directed, dominant intraprostatic lesion (DIL), simultaneous integrated boost (SIB) based on genomic classification in the treatment of localized prostate cancer. The primary purpose of this study is to determine the feasibility and safety of two fraction SBRT in patients with localized prostate cancer.

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

Eligibility

Official eligibility criteria

Inclusion Criteria: * Patient age greater than or equal 18 * Localized adenocarcinoma of the prostate * Biopsy-proven diagnosis of prostate adenocarcinoma * Low to intermediate risk National Comprehensive Cancer Network (NCCN) disease * TX-T2c-8th addition staging * PSA\<20 ng/ml * Grade group 3 or less * Proper rectal space replacement required as determined by the treating radiation oncologist * Prostate size less than 60cc defined at time of simulation based on MRI * Patient ability to undergo MRI and documented dominant Prostate Imaging Reporting and Data System (PI-RADS) 3 or higher lesion \-- Exception is very low risk, low risk, or favorable intermediate risk with a low to intermediate decipher score in which case an SIB is not utilized * Androgen-deprivation therapy (ADT) is left to the discretion of the treating radiation oncologist * Agreement to use effective contraceptive methods such as condoms and spermicidal foam, intrauterine device, or for their partner to use prescription birth control pills * Ability to give informed consent Exclusion Criteria: * High risk disease * Pelvic lymph node involvement * Prophylactic lymph node irradiation requirement as determined by the treating radiation oncologist * Evidence of clinical or radiological extracapsular extension or seminal vesicle invasion * Prior radiation to the pelvis * Prior malignancies within the last 5 years * Inability to meet pre-specified 2 fraction DVH constraints * Prostate size \> 60cc as measures at treatment planning MRI * Active significant inflammatory bowel disease (IBD) or rheumatological disease * Prior prostate surgeries * Previous uro lift * Transurethral resection of the prostate (TURP) within 6 months of SBRT * "Reasonable" urinary, bowel, and erectile function as defined by the pre-treatment EPIC questionnaire (\>50 overall summary score for each domain) * Men of reproductive potential may not participate unless they agree to use an effective contraceptive method

Study sites (2)

NY