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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 weeks3 visits

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

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%

Wound dehiscence

10%

Vascular access complication

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%

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

~2160