RightFit
RecruitingPhase 2

Image-guided, Tumor-focused Radiotherapy Treatment in Intermediate and High-risk Prostate Cancer

RAdiation Dose TAiloRing Guided by Enhanced Targeting

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

Not stated in the study description — ask the study team about visits and procedures.

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 radiation aimed at prostate tumors using images to guide treatment, compared with standard radiation to the whole prostate. It is for adults with intermediate- or high-risk prostate cancer who plan to have radiation treatment. Researchers want to see if tumor-focused treatment causes fewer urinary and bowel side effects.

This is a phase II non-blinded randomized controlled trial of image-guided, tumor-focused radiotherapy in patients with intermediate- or high-risk prostate cancer planning to undergo definitive radiotherapy with or without systemic therapy. The image-guided, tumor-focused radiotherapy will be compared to standard, whole-prostate treatment. The investigators hypothesize that tumor-focused radiotherapy reduces the radiation dose to organs close to the prostate, possibly leading to decreased acute toxicity to the genitourinary and gastrointestinal organs. The investigators will measure acute and late genitourinary and gastrointestinal toxicity due to radiation and regardless of cause. The investigators will also measure overall survival, metastasis-free survival, and quality of life, as well as biomarkers that may help predict, in the future, who may have a worse toxicity following radiation therapy.

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

Eligibility

Who can join

  • Be at least 18 years old.
  • Sign and date a form agreeing to join the study.
  • Be willing to follow all study steps and be available for the full study.
  • Have prostate adenocarcinoma, a type of prostate cancer, confirmed by a tissue sample, and plan to have radiation aimed at curing it.
  • Have a tumor visible on a prostate MRI scan, a PSMA PET-CT scan, or both, as judged by your doctor. The scan must match where cancer was found in biopsy samples.
  • If you can cause a pregnancy, use condoms or another effective birth control method with your partner during radiation and for at least 6 months afterward.

Who can't join

  • Have artificial joints in both hips.
  • Have had surgery to remove the prostate.
  • Have had prostate cancer treatment before. Hormone therapy started within 90 days before random assignment is allowed if scans that meet study requirements were done within 4 months before hormone therapy began.
  • Have had radiation to an area that needs treatment in this study.

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

Official eligibility criteria

Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * At least 18 years old * Histologic confirmation of prostate adenocarcinoma with plan for curative-intent radiation therapy * Lesion visible on prostate Magnetic Resonance Imaging and/or Prostate-Specific Membrane Antigen Positron Emission Tomography-Computed Tomography (according to the treating physician) with concordant pathology from biopsy needle locations. * For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner during the radiation therapy treatment and for at least 6 months afterward. Exclusion Criteria: * Bilateral hip implants * Prior prostatectomy * Prior prostate cancer treatment (for example, focal therapy). Note that participants who started hormone therapy within the 90 days prior to randomization are eligible, as long as study-compatible imaging was performed within the 4 months prior to starting the hormone therapy. * Prior radiation therapy to an area requiring treatment in the present study

Study sites (1)

CA