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Hormone Therapy

Radiation + Hormone Therapy for Prostate Cancer

Phase 1 & 2

Waitlist Available

Led By Daniel Song, M.D.

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

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

Must have

Histologically confirmed, locally confined adenocarcinoma of the prostate

The patient has decided to undergo external beam radiation as treatment choice for his prostate cancer

Must not have

Gleason 8 or higher score

Clinical or Pathological Lymph node involvement (N1)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 2, 3, 6 12, 18. 24, 30, 36 mont, 4 year and 5 year follow-up points after treatment has been completed

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if adding radiation to hormone therapy improves outcomes for prostate cancer patients.

Who is the study for?

Men with intermediate-risk prostate cancer, specifically those with a clinical stage of T2b-T2c, PSA levels between 10-20 ng/mL, or Gleason score of 7. Participants must have chosen external beam radiation as their treatment and not had previous radical prostate surgery, chemotherapy within the last five years for another cancer, pelvic radiation therapy, metastases or certain other cancers.

What is being tested?

The trial is testing how well men with prostate cancer respond to a combination of Androgen Deprivation Therapy (ADT) and Radiation Therapy. It aims to determine the effectiveness and tolerability of this combined approach in treating locally confined adenocarcinoma of the prostate.

What are the potential side effects?

Possible side effects include hot flashes, reduced sexual desire or activity due to ADT; skin irritation, fatigue from radiation therapy; plus potential long-term impacts on urinary and bowel function.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer is confirmed and has not spread outside the prostate.

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I have chosen external beam radiation to treat my prostate cancer.

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My prostate cancer is at an intermediate stage with specific PSA levels and Gleason score.

Exclusion Criteria

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

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My prostate cancer has a Gleason score of 8 or higher.

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My cancer has spread to nearby lymph nodes.

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My cancer has spread to distant parts of my body.

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I have had major surgery for prostate cancer.

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My cancer is at an advanced local stage.

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I have had radiation therapy in the pelvic area before.

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I have a history of inflammatory bowel disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 2, 3, 6 12, 18. 24, 30, 36 mont, 4 year and 5 year follow-up points after treatment has been completed

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 2, 3, 6 12, 18. 24, 30, 36 mont, 4 year and 5 year follow-up points after treatment has been completed

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 2, 3, 6 12, 18. 24, 30, 36 mont, 4 year and 5 year follow-up points after treatment has been completed 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 free-rate

Secondary study objectives

Biomarker Studies

Dose Volume/ Imaging Data Assessments

Gastrointestinal (GI) and Genitourinary (GU toxicity) assessment

+1 more

Side effects data

From 2012 Phase 3 trial • 522 Patients • NCT00242567

23%

PROSTATIC SPECIFIC ANTIGEN INCREASED

21%

BACK PAIN

20%

CONSTIPATION

17%

ARTHRALGIA

16%

PAIN IN EXTREMITY

11%

NAUSEA

11%

BONE PAIN

11%

ANAEMIA

10%

BLOOD CREATININE INCREASED

10%

MUSCULOSKELETAL PAIN

OEDEMA PERIPHERAL

HOT FLUSH

DECREASED APPETITE

DIARRHOEA

UPPER RESPIRATORY TRACT INFECTION

MUSCULOSKELETAL CHEST PAIN

FATIGUE

URINARY TRACT INFECTION

PROSTATE CANCER

WEIGHT DECREASED

INSOMNIA

DYSPNOEA

DYSURIA

DISEASE PROGRESSION

NASOPHARYNGITIS

DIZZINESS

COUGH

FALL

MYALGIA

MUSCULAR WEAKNESS

INFLUENZA LIKE ILLNESS

ABDOMINAL PAIN

VOMITING

PAIN

ASTHENIA

NOCTURIA

LOWER RESPIRATORY TRACT INFECTION

METASTATIC PAIN

WEIGHT INCREASED

HAEMATURIA

HYPERTENSION

HYPOCALCAEMIA

SKIN LACERATION

THROMBOCYTOPENIA

PROSTATE CANCER METASTATIC

MUSCULOSKELETAL DISCOMFORT

MUSCULOSKELETAL STIFFNESS

PARAESTHESIA

POLLAKIURIA

PELVIC PAIN

NECK PAIN

HEADACHE

URINARY RETENTION

DYSPEPSIA

PYREXIA

CEREBRAL HAEMORRHAGE

RENAL FAILURE ACUTE

DEATH

LYMPHADENOPATHY

METASTASES TO BONE

DEHYDRATION

DEPRESSED MOOD

HYDRONEPHROSIS

MUSCLE SPASMS

HYPOAESTHESIA

HYPOPHOSPHATAEMIA

SEPSIS

BRONCHOPNEUMONIA

NEUTROPENIA

ABDOMINAL PAIN UPPER

CEREBRAL INFARCTION

GASTROENTERITIS

MYOCARDIAL INFARCTION

PNEUMONIA

RENAL IMPAIRMENT

CHOLELITHIASIS

CARDIAC FAILURE CONGESTIVE

MALIGNANT NEOPLASM PROGRESSION

METASTASES TO LUNG

LOBAR PNEUMONIA

METASTASES TO CENTRAL NERVOUS SYSTEM

METASTASES TO LIVER

RESPIRATORY FAILURE

BONE MARROW FAILURE

ANGINA PECTORIS

ATRIAL FIBRILLATION

CONCOMITANT DISEASE PROGRESSION

FEMUR FRACTURE

HYPOPHAGIA

CONVULSION

RESPIRATORY ARREST

CHEST PAIN

SPINAL COMPRESSION FRACTURE

PLATELET COUNT DECREASED

CEREBROVASCULAR ACCIDENT

PARAPLEGIA

SPINAL CORD COMPRESSION

CHRONIC OBSTRUCTIVE PULMONARY DISEASE

CARDIAC ARREST

UPPER GASTROINTESTINAL HAEMORRHAGE

BLOOD TESTOSTERONE INCREASED

DIABETES MELLITUS

MALNUTRITION

URINARY TRACT OBSTRUCTION

BENIGN PROSTATIC HYPERPLASIA

DEEP VEIN THROMBOSIS

100%

80%

60%

40%

20%

Study treatment Arm

Delayed Group (Overall)

Early Group

Delayed Group (No Zometa)

Delayed Group (Zometa)

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: Radiation with Androgen Deprivation Therapy (ADT)Experimental Treatment2 Interventions

This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy). This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Androgen Deprivation Therapy (ADT)

2005

Completed Phase 3

~610

Radiation Therapy

2017

Completed Phase 3

~7250