← Back to Search

Hormone Therapy

Shorter Course Hormone + Radiation Therapy for High-risk Prostate Cancer

Phase 2

Waitlist Available

Led By Daniel Gorovets, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Decipher genomic score ≤0.6

Baseline prostate volume ≤90 cc

Must not have

Regional lymph node or metastatic disease

Prior prostate surgery (including TURP or cryosurgery)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new, shorter course of ADT combined with standard prostate brachytherapy and hypofractionated external beam radiation therapy to see if it is effective in preventing high-risk prostate cancer from recurring or spreading.

Who is the study for?

This trial is for men over 18 with high-risk prostate cancer, who haven't had certain other cancers in the last 2 years or treatments like TURP. They should be fit enough for anesthesia and have a life expectancy over 5 years. A genomic score ≤0.6 and no inflammatory bowel disease are also required.

What is being tested?

The study tests if a shorter hormone therapy combined with standard brachytherapy (internal radiation) and hypofractionated external beam radiation can effectively prevent the return or spread of high-risk prostate cancer.

What are the potential side effects?

Possible side effects include urinary issues, bowel problems, sexual dysfunction due to brachytherapy; fatigue, skin reactions from external radiation; and hot flashes, mood swings from hormone therapy.

Eligibility Criteria

Inclusion Criteria

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

Select...

My cancer's genetic score is 0.6 or lower.

Select...

My prostate is smaller than 90 cubic centimeters.

Select...

I can take care of myself and perform daily activities.

Select...

I am 18 years old or older.

Select...

My prostate cancer is advanced, with a high Gleason score or PSA level.

Select...

I have been diagnosed with prostate cancer.

Select...

I have no health issues that prevent me from receiving hormone therapy, seed implantation, or pelvic radiation.

Exclusion Criteria

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

Select...

My cancer has spread to lymph nodes or other parts of my body.

Select...

I have had surgery on my prostate.

Select...

I have a history of inflammatory bowel disease.

Select...

I cannot have anesthesia or specific radiation treatments.

Select...

I have had radiation therapy to my pelvic area before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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

Distant metastatic disease-free (DMF) rate

Secondary study objectives

Acute and late physician-scored toxicity

Side effects data

From 2021 Phase 3 trial • 926 Patients • NCT01414608

79%

Fatigue

76%

Nausea

73%

Diarrhea

71%

Lymphocyte count decreased

65%

Anemia

36%

Vomiting

35%

Abdominal pain

31%

Vaginal discharge

31%

Platelet count decreased

28%

Pelvic pain

26%

Neutrophil count decreased

24%

Peripheral sensory neuropathy

22%

General disorders NOS

20%

Cystitis noninfective

17%

Alanine aminotransferase increased

16%

Pain in extremity

14%

Dermatitis radiation

12%

Creatinine increased

12%

Dehydration

11%

Vaginal pain

10%

Myalgia

10%

Hemorrhage Bladder

Aspartate aminotransferase increased

Hearing impaired

Proctitis

Vaginal dryness

Alopecia

Hemorrhage Rectum

Vaginal stricture

Mucositis oral

Thrombosis/Thrombus/Embolism

Urinary tract pain

Allergic reaction/ hypersensitivity

Rectal pain

Anal pain

Colitis

Lymphedema

Perineal pain

Telangiectasia

Enterocolitis

Febrile neutropenia

Female genital tract fistula

Peripheral motor neuropathy

Tumour pain

100%

80%

60%

40%

20%

Study treatment Arm

Standard Chemoradiation

Standard Chemoradiation With Adjuvant Chemotherapy

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: Hormone Therapy and RadiationExperimental Treatment3 Interventions

Patients enrolled in this study will receive ADT for 6 months which will consist of bicalutamide 50 mg PO daily starting approximately 1-2 weeks before leuprolide 22.5mg injected every 3 months. The HDR prostate brachytherapy procedure will be performed approximately 3 months after starting ADT to allow for potential radiosensitization and cytoreduction. Approximately 4 weeks after the HDR boost, patients will receive image-guided, intensity-modulated, hypofractionated radiation therapy targeting the prostate, seminal vesicles and pelvic lymph nodes to a dose of 25 Gy in 5 fractions delivered daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brachytherapy

2007

Completed Phase 3

~2140

Androgen deprivation therapy (ADT)

2013

Completed Phase 4

~1310