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Brachytherapy

Combined Radiotherapy for Prostate Cancer (HYDRA Trial)

Q: How many individuals are being monitored for this research project?

<p>That is correct, the online information does show that the research team is currently looking for individuals to participate. The posting went up on August 20th 2021 and was last edited on October 13th 2022. They are hoping to have 52 people take part in total, at a single location.</p>

Q: What are the medical researchers anticipating as a result of this clinical trial?

<p>The primary outcome that will be closely monitored and evaluated at the 90 day mark is biochemical failure. Additionally, secondary outcomes such as patient-reported GU symptoms and clinical disease progression to any anatomical site will also be taken into account. These outcomes are defined by EPIC-26 which assesses different <a href="https://www.withpower.com/clinical-trials/prostate-cancer">prostate cancer</a> therapies within the genitourinary summary domain. Response options for each EPIC item form a Likert scale which is then transformed linearly onto a 0-100 scale, with higher scores representing better Health-Related QoL.. Another important metric being looked at is late grade >= 2 GI physician-scored toxicity which will be</p>

N/A

Recruiting

Led By Stephanie M Yoon, MD

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Able to safely receive moderate sedation or general anesthesia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

HYDRA Trial Summary

This trial is testing whether high doses of radiation given directly to the prostate using two different methods can effectively treat prostate cancer with fewer side effects.

Who is the study for?

Men aged 18+ with intermediate to high-risk prostate adenocarcinoma (T1c-T3b, PSA > 10, Gleason score >=7) without metastases or prior major treatments for prostate cancer. They must be able to undergo sedation or anesthesia, have a prostate size <=60cc, and an ECOG performance status of 0-2.Check my eligibility

What is being tested?

The trial is testing the combination of high dose-rate brachytherapy (internal radiation) and stereotactic body radiotherapy (precise external radiation). It aims to see if this approach effectively treats prostate adenocarcinoma with fewer doses and less damage to healthy tissue.See study design

What are the potential side effects?

Potential side effects include irritation or damage to surrounding tissues like the bladder and rectum, urinary issues, bowel changes, fatigue, skin reactions in treated areas, erectile dysfunction, and other localized discomfort.

HYDRA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

Select...

I can safely undergo procedures with sedation or general anesthesia.

Select...

I am 18 years old or older.

Select...

My prostate cancer has not spread beyond the prostate or seminal vesicles.

Select...

My prostate is 60cc or smaller.

Select...

My prostate cancer is confirmed to be at an intermediate to high risk level.

HYDRA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Biochemical failure

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

Secondary outcome measures

Clinical disease progression to any anatomical site

Disease

Distant disease-free survival

+10 more

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446

79%

Cough

64%

Dyspnea

64%

Nausea

57%

Fatigue

43%

Constipation

36%

Pain

36%

Dizziness

29%

Anemia

29%

Back pain

29%

Vomiting

21%

Chest pain

21%

Anorexia

21%

Lymphocyte count decreased

21%

Death NOS

21%

Anxiety

21%

Fall

14%

Wheezing

14%

Dysphagia

14%

Hypotension

14%

Depression

14%

Diarrhea

14%

Platelet count decreased

14%

Abdominal Pain

14%

Edema

14%

Fever

14%

Headache

14%

Insomnia

14%

Palpitations

Alopecia

Creatinine increased

Otitis externa

Dehydration

Sinusitis

Dysgeusia

Hemorrhoids

Amnesia

Confusion

Dementia

Productive cough

Pneumonitis

Dysuria

White blood cell count decreased

Throat pain

Bone marrow biopsy

Hearing impaired

Rash

Hypernatremia

Eye pain

Blurred vision

Tachycardia

Lung infection

Neuropathy

Hypertension

Pleuritic pain

Neutropenia

Hypoxia

Aspiration pneumonia

Blood bilirubin increased

Muscle weakness

Tremor

Weight loss

Thrombocytopenia

Floaters

Toothache

Esophagitis

Leukocytosis

Edema limbs

Gait disturbance

Parathesia (tingling)

Edema face

COPD

100%

80%

60%

40%

20%

Study treatment Arm

Stereotactic Body Radiation Therapy

Maintenance Chemotherapy

HYDRA Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (HDR-BT, SBRT)Experimental Treatment2 Interventions

Patients undergo HDR-BT for up to 24 hours and undergo SBRT every other day or consecutive days for up to 14 consecutive chronologic days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

High-Dose Rate Brachytherapy

2004

Completed Phase 2

~530

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

360 Previous Clinical Trials

27,660 Total Patients Enrolled

Stephanie M Yoon, MDPrincipal InvestigatorUniversity of California, Los Angeles

Media Library

High-Dose Rate Brachytherapy (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04945642 — N/A

Prostate Adenocarcinoma Research Study Groups: Treatment (HDR-BT, SBRT)

Prostate Adenocarcinoma Clinical Trial 2023: High-Dose Rate Brachytherapy Highlights & Side Effects. Trial Name: NCT04945642 — N/A

High-Dose Rate Brachytherapy (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04945642 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being monitored for this research project?

"That is correct, the online information does show that the research team is currently looking for individuals to participate. The posting went up on August 20th 2021 and was last edited on October 13th 2022. They are hoping to have 52 people take part in total, at a single location."

Answered by AI

What are the medical researchers anticipating as a result of this clinical trial?

"The primary outcome that will be closely monitored and evaluated at the 90 day mark is biochemical failure. Additionally, secondary outcomes such as patient-reported GU symptoms and clinical disease progression to any anatomical site will also be taken into account. These outcomes are defined by EPIC-26 which assesses different prostate cancer therapies within the genitourinary summary domain. Response options for each EPIC item form a Likert scale which is then transformed linearly onto a 0-100 scale, with higher scores representing better Health-Related QoL.. Another important metric being looked at is late grade >= 2 GI physician-scored toxicity which will be"

Answered by AI

Are we still able to enroll in this experiment?

"This study is actively recruiting patients, as reported on clinicaltrials.gov. The trial was first posted on 8/20/2021 and was last updated on 10/13/2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04945642.

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