Radical Hypofractionated Radiotherapy for Localized Prostate Cancer

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• Prostatic Neoplasms 6,370

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 20 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Lead sponsor

Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.

Study arms

• Experimental
  Hypofractionated Radiotherapy

  Hypofractionated Radiotherapy over 3 weeks.

  Radiation: Hypofractionated radiation therapy

Interventions

• RadiationHypofractionated radiation therapy

  54 Gy in 15 daily fractions of 3.6 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.

Primary outcomes

1. Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events

   RTOG / EORTC scale, Common Terminology Criteria for Adverse Events (CTCAE) 5.0, erectile dysfunction.

   Time frame: 5 years

Secondary outcomes

1. biochemical progression-free survival (bPFS)

   The definition of biochemical failure is a PSA measurement ≥ PSA nadir + 2 ng/mL where nadir is the lowest post-RT PSA value.Time to biochemical failure is defined as time from randomization to the date of first biochemical failure, last known follow-up (censored), or death without biochemical failure (competing risk).

   Time frame: 5 years

2. local progression-free-survival(LPFS)

   Response evaluation criteria in solid tumor（RECIST）1.1:To determine the outcome of treatment for solid tumors,The efficacy according the diameter of the lesion could be divided into complete response（CR），partial response（PR）,stable disease（SD）and progressive disease（PD）.

   Time frame: 5 years

3. distant metastasis free survival(DMFS)

   Distant metastasis (failure) is defined as radiographic evidence of hematogenous spread evaluated by bone scan, CT, or MRI. Time to distant metastasis is defined as time from randomization to the date of first distant metastasis, last known follow-up (censored), or death without local recurrence (competing risk).

   Time frame: 5 years

4. Overall survival (OS)

   Overall survival time is defined as time from registration/randomization to the date of death (failure) from any cause or last known follow-up (censored).

   Time frame: 5 years

5. Quality of life (QoL)

   Expanded Prostate Cancer Index (EPIC-26)：The EPIC is a prostate cancer health-related quality of life (HRQOL) self-administered instrument measuring patient-reported urinary, bowel, sexual, and hormonal symptoms related to prostate cancer treatments. Response options for each item form a Likert scale with scores transformed linearly to a 0-100 scale. Domain scores are also on a 0-100 scale with higher scores representing better HRQOL.

   Time frame: 5 years

6. Physical Activity Rank Scale-3 (ARS-3)

   To assess the physical activity rank.The scale was compiled by Japanese psychologist KIMIO HASHIMOTO and introduced and revised by Liang Deqing from Wuhan Physical Education University. There are only 3 items in this scale, which adopts 5 grades from 1 to 5, and examines the level of physical activity from 3 aspects: intensity, time and frequency of participating in physical activity

   Time frame: 5 years

Individual participant data

Plan to share: Yes — Individual participant data including baseline characteristics,treatment information and follow-up data on toxicity, survival and disease control will be shared.

Supporting information: Study protocol