Health TrialsbyHealthPanel

High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma

ConditionsProstate AdenocarcinomaStage IIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8Stage IIC Prostate Cancer AJCC v8Stage III Prostate Cancer AJCC v8Stage IIIA Prostate Cancer AJCC v8Stage IIIB Prostate Cancer AJCC v8Stage IIIC Prostate Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorJonsson Comprehensive Cancer Center

About this trial

This phase II trial investigates the effect of high dose-rate brachytherapy and stereotactic body radiotherapy in treating patients with prostate adenocarcinoma. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability to understand a written informed consent document, and the willingness to sign it

Age >= 18 years

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration

Disqualifiers

Patients with neuroendocrine or small cell carcinoma of the prostate

Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years

Regional lymph node involvement

Evidence of distant metastases

Trial design

Design model

Single group

Treatments tested in this trial

  • High-Dose Rate Brachytherapy

    Radiation

    Undergo HDR-BT

  • Stereotactic Body Radiation Therapy

    Radiation

    Undergo SBRT

Treatment groups

52 Participants
are divided into 1 treatment group
Group A: Treatment (HDR-BT, SBRT)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Biochemical failure

Will be based on Phoenix criteria (either a rise of 2 ng/mL or more above nadir prostate specific antigen \[PSA\], or patients not meeting this criterion but underwent salvage therapies). The biochemical progression free survival (b-PFS) will be defined from the date of completing radiotherapy to the date biochemical failure, death, or last follow-up, stratified by prostate cancer risk classification. Kaplan-Meier method will be used.

Time frame
Up to 5 years
2

Patient-reported genitourinary (GU) and gastrointestinal (GI) symptoms

Will be assessed on the Expanded Prostate Cancer Index-26 (EPIC-26) questionnaire.

Time frame
At 90 days

Secondary outcomes

1

Patient-reported GU symptoms

Will be assessed on EPIC-26. EPIC assesses the disease-specific aspects of prostate cancer and its therapies within the genitourinary summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.

Time frame
At end of radiotherapy, 6, 12, 24, and 60 months
2

Patient-reported GI symptoms

Will be assessed on EPIC-26. EPIC assesses the disease-specific aspects of prostate cancer and its therapies within the gastrointestinal summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.

Time frame
At end of radiotherapy, 6, 12, 24, and 60 months
3

The acute grade >= 2 GU physician-scored toxicity

Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Time frame
Up to 90 days from treatment completion
4

The acute grade >= 2 GI physician-scored toxicity

Will be assessed by CTCAE version 5.0.

Time frame
Up to 90 days from treatment completion

Other outcomes

Sponsors and contacts

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

Jonsson Comprehensive Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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