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Radiation Therapy

Radiation Therapy for Prostate Cancer

Phase 2

Waitlist Available

Led By Brian J. Davis, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Limited to pelvic and/or retroperitoneal/para-aortic lymph nodes

Histological confirmation of prostate adenocarcinoma

Must not have

Bone or visceral metastases present

Contraindications to androgen suppression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from registration until the death due to any cause, assessed at 2 and 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a shorter course of radiation therapy is better for patients with recurrent prostate cancer, with fewer side effects.

Who is the study for?

Men over 18 with recurrent prostate cancer limited to certain lymph nodes, who've had primary radiotherapy. They must have a good performance status (able to carry out daily activities) and no bone or visceral metastases, other recent malignancies, or conditions that prevent radiation therapy or informed consent.

What is being tested?

The trial is testing two types of radiation: Hypofractionated Proton Beam Therapy which gives smaller doses over time, and IMRT which uses high-energy x-rays. The goal is to see if a shorter course of radiation can effectively treat recurrent prostate cancer with fewer side effects.

What are the potential side effects?

Potential side effects include skin reactions in the treated area, fatigue, bowel and bladder issues such as diarrhea or increased frequency of urination, erectile dysfunction, and possibly inflammation of surrounding organs.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is only in my pelvic or nearby lymph nodes.

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My prostate cancer has been confirmed through a biopsy.

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I am a man aged 18 or older.

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My prostate cancer has returned after I had radiation therapy.

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My cancer has returned and spread to my lymph nodes, confirmed by advanced PET scans.

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My cancer has spread but only to a few places.

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I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

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

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My cancer has spread to my bones or internal organs.

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I cannot undergo treatments that lower testosterone levels.

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I do not have conditions like uncontrolled IBD that prevent radiation therapy.

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I am not currently taking any cancer drugs.

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My cancer has spread to lymph nodes beyond my pelvis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from registration until the death due to any cause, assessed at 2 and 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from registration until the death due to any cause, assessed at 2 and 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from registration until the death due to any cause, assessed at 2 and 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

Proportion of patients who experience a late (>= 90 days after radiation therapy [RT] start date) grade 3 or higher gastrointestinal (GI) and/or genitourinary (GU) adverse event (AE)

Secondary study objectives

Incidence of acute adverse events

Incidence of adverse events

Incidence of late adverse events

+1 more

Other study objectives

Disease-free survival

Disease-specific survival

Expanded Prostate Cancer Index Composite short form (EPIC-26) questionnaire

+1 more

Side effects data

From 2013 Phase 3 trial • 637 Patients • NCT00884741

30%

Fatigue

20%

Thrombosis

20%

Nausea

20%

Hemoglobin decreased

20%

Lymphopenia

20%

Alanine aminotransferase increased

20%

Hyperglycemia

20%

Hyponatremia

20%

Seizure

10%

Alopecia

10%

Weight loss

10%

Opportunistic infection

10%

Dry mouth

10%

Wound infection [with normal or Grade 1-2 ANC]

10%

Wound infection [with unknown ANC]

10%

Vascular access complication

10%

Wound dehiscence

10%

Dysphagia

10%

Acoustic nerve disorder NOS

10%

Anorexia

10%

Dehydration

10%

Eye disorder

10%

Disease progression

10%

Headache

10%

Hearing loss

10%

Tinnitus

10%

Fracture

10%

Creatinine increased

10%

Hyperkalemia

10%

Hypermagnesemia

10%

Hypoalbuminemia

10%

Muscle weakness left-sided

10%

Memory impairment

10%

Neurological disorder NOS

10%

Taste alteration

10%

Depression

10%

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Pre-Randomization TMZ+RT

Randomized Arm 1: TMZ+RT + Placebo

Randomized Arm 2: TMZ+RT + Bevacizumab

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (IMRT)Experimental Treatment5 Interventions

Patients undergo IMRT 5 days a week over 5 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.

Group II: Arm I (proton beam radiation therapy)Experimental Treatment6 Interventions

Patients undergo proton beam radiation therapy 5 days a week over 3 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2790

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180