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Brachytherapy

Combined Radiotherapy for Prostate Cancer (HYDRA Trial)

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

Must not have

Previous radical surgery (prostatectomy) or cryosurgery or high-intensity focused ultrasound for prostate cancer

Patients with history of inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis), high predisposition for radio-toxicity compared to general population (i.e., ataxia telangiectasia), or at risk for major bowel surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

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I can safely undergo procedures with sedation or general anesthesia.

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I am 18 years old or older.

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

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My prostate is 60cc or smaller.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery or specific treatments for prostate cancer.

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I have a history of inflammatory bowel disease or a high risk for radiation side effects.

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I have had radiation treatment to my pelvis or seed implant therapy in my prostate.

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My prostate cancer is of the neuroendocrine or small cell type.

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I had a prostate surgery (TURP) within the last 6 months before my radiation treatment.

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My cancer has spread to distant parts of my body.

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My cancer has spread to nearby lymph nodes.

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I have received chemotherapy for prostate cancer.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Biochemical failure

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

Secondary study objectives

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

87%

Fatigue

53%

Nausea

33%

Cough

27%

Pain

27%

Fall

27%

Dyspnea

27%

Depression

27%

Lymphocyte count decreased

27%

Platelet count decreased

27%

Anemia

20%

Chills

20%

Dizziness

20%

Chest pain

20%

Neutropenia

20%

Diarrhea

20%

Edema limbs

13%

Dysesthesia

13%

Insomnia

13%

Edema

13%

Constipation

13%

Delirium

13%

Dysgeusia

13%

Skin infection

13%

Vomiting

13%

Tinnitus

13%

Rash

13%

Myalgia

13%

Back pain

13%

Weakness (limb)

13%

Weight loss

Proteinuria

Hearing loss

Anxiety

Oral lesions

Headaches

Acute kidney injury

Bruising

Hypokalemia

Lymphocytopenia

Seizures

Weakness (facial)

Hearing impaired

Neutrophil count decreased

Death NOS

Hypertension

Headache

Creatinine increased

Fever

Pleural effusion

Gait disturbance

Nasal congestion

Tremor

Urinary urgency

Amnesia

Hypernatremia

Photophobia

Urinary frequency

Dysphagia

Low white blood count

Sneezing

Cognitive disturbance

Erythema multitforme

Lung infection

Allergy (seasonal)

Muscle weakness

Hypomagnesemia

Parathesia (tingling)

Febrile Neutropenia

Anorexia

Hypoxic respiratory failure

Sleep apnea

Encephalopathy

Hypoxia

Shingles

100%

80%

60%

40%

20%

Study treatment Arm

Maintenance Chemotherapy

Stereotactic Body Radiation Therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~790