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Hormone Therapy

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

Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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My cancer's genetic score is 0.6 or lower.
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My prostate is smaller than 90 cubic centimeters.
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I can take care of myself and perform daily activities.
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I am 18 years old or older.
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My prostate cancer is advanced, with a high Gleason score or PSA level.
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I have been diagnosed with prostate cancer.
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I have no health issues that prevent me from receiving hormone therapy, seed implantation, or pelvic radiation.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Distant metastatic disease-free (DMF) rate
Secondary outcome measures
Acute and late physician-scored toxicity
Cumulative incidence of biochemical failure
Overall survival rate
+1 more

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
9%
Aspartate aminotransferase increased
9%
Hearing impaired
8%
Proctitis
8%
Vaginal dryness
8%
Alopecia
7%
Hemorrhage Rectum
7%
Vaginal stricture
6%
Mucositis oral
6%
Thrombosis/Thrombus/Embolism
6%
Urinary tract pain
4%
Allergic reaction/ hypersensitivity
4%
Rectal pain
3%
Anal pain
3%
Colitis
3%
Lymphedema
2%
Perineal pain
2%
Telangiectasia
2%
Enterocolitis
2%
Febrile neutropenia
2%
Female genital tract fistula
2%
Peripheral motor neuropathy
2%
Tumour pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Chemoradiation
Standard Chemoradiation With Adjuvant Chemotherapy

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
~2100
Androgen deprivation therapy (ADT)
2013
Completed Phase 4
~1310

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,938 Previous Clinical Trials
588,319 Total Patients Enrolled
132 Trials studying Prostate Cancer
51,462 Patients Enrolled for Prostate Cancer
Daniel Gorovets, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
311 Total Patients Enrolled
3 Trials studying Prostate Cancer
311 Patients Enrolled for Prostate Cancer

Media Library

Androgen deprivation therapy (ADT) (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05100472 — Phase 2
Androgen deprivation therapy (ADT) (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05100472 — Phase 2
Prostate Cancer Clinical Trial 2023: Androgen deprivation therapy (ADT) Highlights & Side Effects. Trial Name: NCT05100472 — Phase 2
Prostate Cancer Research Study Groups: Hormone Therapy and Radiation

Frequently Asked Questions

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

Is this experiment presently open to recruitment?

"Data on clinicaltrials.gov verifies that this research is actively enrolling patients, with the trial first being posted on October 19th 2021 and last updated November 2nd 2022."

Answered by AI

Has the Federal Drug Administration certified Brachytherapy as an acceptable treatment?

"Brachytherapy has been given a safety rating of 2 because there is evidence to support its security, yet the efficacy remains unconfirmed."

Answered by AI

How many physical locations are overseeing this clinical examination?

"Currently, the trial is enrolling participants at 7 different medical sites. These locations include Commack, Harrison and Montvale as well as 4 other locales. Selecting a nearby site will help minimise any travel obligations for those involved in this study."

Answered by AI

How many volunteers are involved in this experiment?

"That is correct. Clinicaltrials.gov reveals that, as of November 2nd 2022, this clinical trial remains open and searching for 50 participants across 7 different sites - the program was initially posted on October 19th 2021."

Answered by AI
~6 spots leftby Oct 2024