Study on Hypofractionated Radiotherapy with a Targeted Boost for High-Risk and Locally Advanced Prostate Cancer

Sponsor: Medical University of South Carolina

Sponsor score: 0

ClinicalTrials ID:NCT07325721

Provider View

This clinical trial is exploring the safety and effectiveness of two new radiation techniques for treating men with high-risk or locally advanced prostate cancer. Participants will undergo standard care visits, complete questionnaires, and provide blood samples for research. The study lasts about 6 weeks, with follow-ups every three months for two years, then twice a year for up to five years.

Patient Parameters

Program Overview

This study is for men with high-risk or locally advanced prostate cancer that has not been treated before. It aims to test the safety and effectiveness of combining two new radiation techniques: hypofractionated radiotherapy and a microboost technique. Participants will have regular medical visits, fill out questionnaires, and provide blood samples for research. There is also an option to store blood and prostate biopsy tissue for future research, which does not require extra biopsies. The study will last about 6 weeks, with follow-up visits every three months for two years, and then twice a year for the next three years.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 and older who agree to participate and follow study procedures.
  • Have not received previous treatments like chemotherapy, surgery, or radiation for prostate cancer, except for a prostate procedure done at least 90 days before starting radiation.
  • Diagnosed with high-risk or locally advanced prostate cancer, meeting specific medical criteria such as high PSA levels, certain tumor stages, or Gleason scores.
  • Able to undergo pelvic radiotherapy and follow the treatment plan.
  • Have a visible target for the microboost on an MRI scan.
  • Agree to use effective contraception during and for six months after radiation treatment.
  • Have adequate blood and liver function based on recent tests.
  • Willing to receive long-term hormone therapy as part of standard prostate cancer treatment.

Exclusion Criteria

  • Currently using testosterone supplements unless stopped before joining the study.
  • Evidence of cancer spread outside the pelvic area on scans.
  • Previous pelvic radiation therapy.
  • Health conditions that prevent receiving curative radiation therapy or a life expectancy of less than five years.
  • Participation in another prostate cancer treatment study within the past year.
  • Previous prostate surgeries or treatments like prostate removal or ablation.
  • Other cancers within the past five years, except for certain skin cancers.
  • Any condition that the study doctor believes would prevent participation.
  • Previous hormone therapy for prostate cancer is allowed only if started within 90 days before joining the study.
  • Unable to have certain markers or gels implanted for the study.
  • Other cancers or treatments that could interfere with the study's safety or effectiveness.

Locations

FACILITYZIPCITYSTATE
Medical University of South Carolina Hollings Cancer Center29425CharlestonSouth Carolina

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