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Hypofractionated Radiotherapy With a Focal Microboost for High-Risk and Locally Advanced Prostate Cancer

ConditionsProstate CancerProstate Cancer Patients Treated by Radiotherapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorMedical University of South Carolina

About this trial

This study is for adult men with previously untreated high risk, very high risk, or pelvic lymph node positive prostate cancer. The purpose of this study is to evaluate the safety and effectiveness of the combination of two emerging radiation treatment techniques (hypofractionated radiotherapy and microboost technique). Participation will include standard of care visits along with questionnaires and blood draws completed for research purposes. There is optional banking of blood and prostate biopsy tissue which will not require extra biopsies. Participation in this study is anticipated to last approximately 6 weeks with follow up every three months for two years then twice yearly for years 3-5.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated informed consent form.

Stated willingness to comply with all study procedures and availability for the duration of the study.

Biologically male patients aged 18 years and older.

Ability to receive pelvic radiotherapy and be willing to adhere to the protocol regimen.

Disqualifiers

1. Concurrent use of testosterone supplementation unless discontinued by time of registration.

Trial design

Design model

Single group

Treatments tested in this trial

  • Hypofractionated radiation with a microboost

    Radiation

    Patients will receive 25 fractions of external beam radiation therapy. Dose to the elective lymph nodes will be 45 Gy in 25 fractions. Dose to the prostate and portions of the seminal vesicles will be 68 Gy in 25 fractions. A microboost to up to three dominant intraprostatic nodules will be given in 25 fractions (dose range 70-83 Gy). Simultaneous integrated boost to sites of pelvic lymphadenopathy may be given. Androgen deprivation therapy will be per local standard of care.

Treatment groups

46 Participants
are divided into 1 treatment group
Group A: Hypofractationed pelvic radiation with microboostExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

CTCAE grade 2 or higher acute genitourinary toxicity

Time frame
1 month post radiation

Secondary outcomes

1

grade 2 or higher acute GI toxicity, late GU toxicity and late GI toxicity

Time frame
5 years
2

PSA failure rate

Time frame
2 years
3

death from any cause

Time frame
5 years
4

Mean change in Sexual Health Inventory for Men (SHIM) score

Time frame
5 years

Other outcomes

Sponsors and contacts

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

Medical University of South Carolina

Lead sponsor

Source ClinicalTrials.gov
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