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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
Patients with histologically proven diagnosis of adenocarcinoma of the prostate stage N1, N2, N3, M1a, M1b, M1c with =< 5 metastatic lesions
Prior radiation therapy for metastatic disease is not allowed
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

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer is advanced with 5 or fewer spread sites.
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I have not had radiation for cancer that has spread.
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I have not had chemotherapy for cancer that has spread.
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I can perform daily activities with little to no assistance.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to Prostate-specific Antigen (PSA) Relapse
Secondary outcome measures
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

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
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Bicalutamide
2003
Completed Phase 3
~5330
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
558 Previous Clinical Trials
1,917,422 Total Patients Enrolled
14 Trials studying Prostate Cancer
5,613 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,607 Previous Clinical Trials
40,914,133 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,154 Patients Enrolled for Prostate Cancer
Cy A SteinPrincipal InvestigatorCity of Hope Medical Center

Media Library

Bicalutamide (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00544830 — Phase 2
Prostate Cancer Research Study Groups: Treatment (androgen therapy, radiation therapy)
Prostate Cancer 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

Frequently Asked Questions

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

What past researches have been conducted using Intensity-Modulated Radiation Therapy?

"Presently, 219 trials concerning Intensity-Modulated Radiation Therapy are in progress with 64 of them being Phase 3. While some clinical tests for this therapy take place in Duarte, California, 8,829 other centres offer the same kind of assessment."

Answered by AI

What is the objective of this research endeavor?

"The primary measure of success for this trial, measured over a 40 week period, is the rate at which Prostate-specific Antigen (PSA) relapse. Secondary outcomes include time to progression and PSA response to treatment; with 36 weeks of androgen deprivation therapy being used as an estimate. Additionally, the feasibility of using helical tomotherapy image-guided radiation therapy will be assessed by determining what percentage of patients were able to receive IGRT via tomotherapy."

Answered by AI

Are there any openings available for participants in this research?

"According to clinicaltrials.gov, this particular study has been inactive since April 4th 2022 and is not presently recruiting patients. However, there are currently 993 other trials searching for participants at the moment."

Answered by AI

Has the FDA sanctioned Intensity-Modulated Radiation Therapy?

"With the available evidence, our team at Power believes Intensity-Modulated Radiation Therapy is relatively safe and gave it a score of 2. This medical intervention has been studied in phase two trials that indicate safety but not efficacy yet."

Answered by AI

In what type of medical cases is Intensity-Modulated Radiation Therapy typically recommended?

"Intensity-Modulated Radiation Therapy (IMRT) is often employed to treat cervical syndrome, minor burns, stage t2b prostate carcinoma and post-transplantation."

Answered by AI

What is the aggregate size of participants in this experimental endeavor?

"This research initiative has concluded its recruitment period, as the study was last updated on April 4th 2022. However, for those still seeking to participate in a trial, 774 programs are recruiting patients with adenocarcinoma and 219 trials are enrolling individuals requiring Intensity-Modulated Radiation Therapy."

Answered by AI

Is this experimental process a pioneering endeavor?

"Since the first clinical trial in 2000, sponsored by AstraZeneca and involving 600 participants, Intensity-Modulated Radiation Therapy has undergone extensive study. This work culminated with Phase 3 drug approval prior to its current state of 219 active studies spanning 56 countries and 1452 cities."

Answered by AI
~2 spots leftby Mar 2025