Active — Not RecruitingNot Applicable

Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) For Prostate Cancer

United States, Australia, Italy161 participantsStarted 2013-04-04

Plain-language summary

Accelerated Hypofractionation Radiotherapy for prostate cancer of 36.25 Gy delivered in 5 fractions will not be inferior to the standard treatment of 70.2 Gy given in 26 fractions with respect to four-year biochemical failure (PSA failure) by Phoenix definition post-treatment completion.

Who can participate

Age range35 Years – 85 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Histologically proven prostate adenocarcinoma.
✓. Clinical stage ≤ T2 based on DRE and/or ≤ T3a based on MRI (if done); N0-Nx; M0-Mx (AJCC 7th Edition)
✓. Prostate-Specific Antigen (PSA) \< 20 ng/ml, obtained no greater than 3 months prior to enrollment.
✓. Patients belonging in one of the following risk groups:
✓. Prostate volume: ≤ 80 cc.
✓. Zubrod performance status 0-1.
✓. No prior total prostatectomy or cryotherapy of the prostate.
✓. No prior radiotherapy to the prostate or lower pelvis.

Exclusion criteria

✕. Does not have a diagnosis of prostate adenocarcinoma.
✕. Patient has clinical T3a or any evidence of T3b disease.
✕. Patient has stage N1 or M1 disease.
✕. Patients has a PSA of greater than 20 ng/ml, obtained no greater than 3 months prior to randomization.
✕. Patient does not meet any of the risk groups outlined in section 3.1.4.
✕. Prostate volume greater than 80 cc.

What they're measuring

Number of Participants Achieving Four-Year Biochemical Failure.

Timeframe: Up to 4 years (After Completion of Intervention)

Trial details

NCT IDNCT01794403

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02-01

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