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RecruitingPhase 2

Androgen-responsive POSLUMA-guided Intra-prostatic Boost

Androgen-responsive POSLUMA-guided Intra-prostatic Boost (ARPEGGIO)

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
  • Procedures mentioned: MRI scans, CT scans, PET 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
  • "However, after hormone therapy starts, it can become harder for doctors to tell exactly where active cancer remains inside the prostate using standard imaging (typically an MRI)."
  • "In addition, participants will undergo PSMA PET/CT scans, a type of imaging that highlights prostate cancer cells, as well as MRI scans."
  • "Participants will receive high-precision radiation (stereotactic body radiation therapy/SBRT) to the prostate over about two weeks."
  • "The main goal of the study is to understand whether doctors can confidently use the mid-treatment PSMA PET/CT scan to guide radiation planning."
  • "Participation in this study lasts about 6 months, and all treatments provided are commonly used in prostate cancer care, with the incorporation of PSMA PET scans being the experimental component."
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 men with intermediate- or high-risk prostate cancer who plan to get hormone therapy and radiation. It tests whether special scans during hormone therapy can help doctors better aim extra radiation at cancer that remains. Everyone will get standard hormone therapy and radiation, plus three scans over six months.

This research study is for men with intermediate- or high-risk prostate cancer who are planning to receive hormone therapy and radiation treatment. The purpose of the study is to see whether a special type of diagnostic imaging done during hormone therapy can help doctors more accurately target remaining cancer with radiation, while avoiding areas that may no longer need extra treatment. All participants will receive standard hormone therapy and radiation therapy, along with three imaging scans, over a six-month period. The information gained from this study may help make prostate cancer radiation treatment more precise and reduce side effects for future patients.

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

Eligibility

Who can join

  • You are age 18 or older.
  • You can do daily tasks, with little or no limit on physical activity.
  • A tissue test has confirmed prostate cancer.
  • Your cancer is intermediate- or high-risk, and an MRI will help show how far it has grown.
  • An MRI done within 180 days before screening shows at least one highly suspicious area, rated PI-RADS 4 or 5.
  • A PSMA PET scan done within 180 days before screening shows a matching area that stands out from nearby prostate tissue.
  • You plan to get SBRT, a focused type of radiation, in five treatments, with extra radiation to one cancer area seen on both scans.

Who can't join

  • Scans show cancer in lymph nodes or farther away, or you have stage T4 cancer, which has grown into nearby tissues or organs.
  • You plan to get added hormone-blocking drugs or chemotherapy.
  • You have had hormone therapy to lower male hormones, radiation to the pelvis, or prostate surgery, including TURP surgery to remove prostate tissue.
  • Your urinary symptom score is above 20, or you have had narrowing of the tube that carries urine out of the body.
  • Your prostate is larger than 80 cc on MRI.
  • You have hip implants that make prostate scan images unclear.
  • You cannot stop blood thinners to have small markers placed to guide radiation.
  • You have active Crohn's disease, which causes swelling in the digestive tract, or scleroderma, which causes hardening of skin and other tissues.

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

Official eligibility criteria

Inclusion Criteria: * 18 years of age and older. * Eastern Oncology Group Status 0 to 1. * Histologic diagnosis of prostate cancer. * Prior screening MRI with at least one PI-RADS4 or PI-RADS 5 lesion, obtained within 180 days of screening. * NCCN intermediate-risk or high-risk prostate cancer (Appendix B). All patients will be staged by MRI. * Prior PSMA PET scan with at least one focal avid lesion greater than background prostate that is concordant with a lesion on MRI, obtained within 180 days of screening. * Intention for SBRT (36.25 Gy/5 fraction) with focal boost (up to 50 Gy) to one MRI/PET-concordant lesion34. Exclusion Criteria: * Prior imaging (CT, bone scan, MRI, PSMA-PET/CT) showing nodal or distant disease. * Intention to receive treatment intensification with secondary androgen receptor signaling inhibitors or chemotherapy. * Clinical T4 disease. * Prior ADT. * Prior pelvic RT. * Prior prostate surgery, including TURP. * International prostate symptom score \> 20. * Prior urethral stricture. * Prostate volume \> 80 cc on MRI. * Hip implants that cause artifacts over the prostate gland. * Inability to discontinue anti-coagulation for fiducial marker placement. * Active Crohn's disease or scleroderma.

Study sites (4)

MA