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Hormone Therapy

Hormone + Radiation Therapy for Metastatic Prostate Cancer

Phase 2
Waitlist Available
Led By Cy A Stein
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients are evaluated for disease on day 1 of each of three 12-week cycles. after the last cycle of anti-androgen therapy, patients are assessed every four weeks until psa relapse occurs, up to 61.4 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying how well hormone therapy and radiation therapy work in treating patients with prostate cancer that has spread to other places in the body.

Who is the study for?
This trial is for men with metastatic prostate cancer who haven't had prior radiation for metastasis, have a good performance status (WHO 0-2), and have limited number of lesions. They should not have brain metastases or severe medical conditions, no history of orchiectomy, and must not be refractory to hormone therapy.
What is being tested?
The study tests if combining hormone therapy (goserelin, leuprolide acetate, bicalutamide) with targeted high-dose radiation (intensity-modulated radiation therapy) can better treat prostate cancer that has spread compared to standard treatments.
What are the potential side effects?
Potential side effects include hot flashes, fatigue, sexual dysfunction due to hormone therapy; skin irritation and potential damage to nearby organs from the targeted radiation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients are evaluated for disease on day 1 of each of three 12-week cycles. after the last cycle of anti-androgen therapy, patients are assessed every four weeks until psa relapse occurs, up to 61.4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and patients are evaluated for disease on day 1 of each of three 12-week cycles. after the last cycle of anti-androgen therapy, patients are assessed every four weeks until psa relapse occurs, up to 61.4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to Prostate-specific Antigen (PSA) Relapse
Secondary study objectives
CR Without ADT in Patients With Metastases Limited to Pelvic Lymph Nodes.
Count of Patients Remaining Off of Therapy
Follow-up of the 8 Patients With Metastases Limited to Pelvic Lymph Nodes.
+3 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%
0%
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

1Treatment groups
Experimental Treatment
Group I: Treatment (androgen therapy, radiation therapy)Experimental Treatment5 Interventions
ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy. RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bicalutamide
2003
Completed Phase 3
~6210
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2140
Leuprolide Acetate
2002
Completed Phase 3
~1890
Goserelin Acetate
2007
Completed Phase 3
~1040

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,418 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,159 Total Patients Enrolled
Cy A SteinPrincipal InvestigatorCity of Hope Medical Center

Media Library

Bicalutamide (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00544830 — Phase 2
Prostate-Specific Antigen Research Study Groups: Treatment (androgen therapy, radiation therapy)
Prostate-Specific Antigen Clinical Trial 2023: Bicalutamide Highlights & Side Effects. Trial Name: NCT00544830 — Phase 2
Bicalutamide (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00544830 — Phase 2
~1 spots leftby Dec 2025