Health TrialsbyHealthPanel

Radical Hypofractionated Radiotherapy for Localized Prostate Cancer

ConditionLocalized Prostate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorChanghai Hospital

About this trial

The aim of this trial is to study the safety outcomes of hypofractionated radiotherapy in treating patients with localized prostate cancer.

Hypofractionated radiotherapy delivers higher doses of radiotherapy in a shorter time period, may enabling the killing of more tumor cells with fewer side effects.

Accumulating evidence has proven the safety and feasibility of hypofractionated radiotherapy for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of hypofractionated radiotherapy is still on its way.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: ≥18 years old;

European Cooperative Oncology Group score(ECOG):≤ 2;

Patients with pathologically diagnosed prostate cancer;

Clinical stage was cTanyN0M0 any Gleason / ISUP group;

Disqualifiers

Patients who have received any other early treatment for prostate cancer, including radiotherapy, chemotherapy, focal therapy, etc;

a previous history of pelvic and abdominal radiotherapy;

Prior hormonal therapy (castration or antiandrogen);

Patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and/or positive syphilis;

Trial design

Design model

Single group

Treatments tested in this trial

  • Hypofractionated radiation therapy

    Radiation

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Hypofractionated RadiotherapyExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Changhai Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now