Quality-of-Life Assessment for Prostate Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Prostate Cancer+4 MoreQuality-of-Life Assessment - Other
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is testing whether adding surgery or radiation therapy to standard treatment for prostate cancer that has spread to other parts of the body lowers the chance of the cancer growing or spreading.

Eligible Conditions
  • Prostate Cancer
  • Stage IVA Prostate Cancer
  • Stage IVB Prostate Cancer
  • Low Testosterone
  • Stage IV Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 8 years

Year 8
Media OS
Overall survival (OS)
Year 8
Progression-free survival (PFS)
Up to 8 years
Rate of symptomatic local progression

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
48%Blood or bone marrow
42%Metabolic or laboratory-testing result
40%Hepatic
36%General
28%Constitutional symptoms
26%Neurologic
22%Pulmonary
21%Gastrointestinal
19%Renal or genitourinary
19%Arrhythmia
13%Pain
8%Infection or febrile neutropenia
7%Skin
7%Musculoskeletal
2%Death
This histogram enumerates side effects from a completed 2011 Phase 3 trial (NCT00019682) in the Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin) ARM group. Side effects include: Blood or bone marrow with 48%, Metabolic or laboratory-testing result with 42%, Hepatic with 40%, General with 36%, Constitutional symptoms with 28%.

Trial Design

3 Treatment Groups

Arm I (SST)
1 of 3
Step 1 (pre-randomization)
1 of 3
Arm II (SST, prostatectomy or radiation therapy)
1 of 3

Active Control

Experimental Treatment

1273 Total Participants · 3 Treatment Groups

Primary Treatment: Quality-of-Life Assessment · No Placebo Group · Phase 3

Arm II (SST, prostatectomy or radiation therapy)Experimental Group · 13 Interventions: Orchiectomy, Abiraterone, Degarelix, Histrelin Acetate, Radical Prostatectomy, Flutamide, Triptorelin, Goserelin Acetate, Radiation Therapy, Quality-of-Life Assessment, Bicalutamide, Leuprolide Acetate, Nilutamide · Intervention Types: Procedure, Drug, Drug, Drug, Procedure, Drug, Drug, Drug, Radiation, Other, Drug, Drug, Drug
Arm I (SST)ActiveComparator Group · 11 Interventions: Orchiectomy, Abiraterone, Degarelix, Histrelin Acetate, Flutamide, Triptorelin, Goserelin Acetate, Quality-of-Life Assessment, Bicalutamide, Leuprolide Acetate, Nilutamide · Intervention Types: Procedure, Drug, Drug, Drug, Drug, Drug, Drug, Other, Drug, Drug, Drug
Step 1 (pre-randomization)ActiveComparator Group · 13 Interventions: Orchiectomy, Abiraterone, Degarelix, Docetaxel, Histrelin Acetate, Prednisone, Flutamide, Triptorelin, Goserelin Acetate, Quality-of-Life Assessment, Bicalutamide, Leuprolide Acetate, Nilutamide · Intervention Types: Procedure, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Other, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Orchiectomy
2010
Completed Phase 4
~50
Abiraterone
FDA approved
Degarelix
FDA approved
Radical Prostatectomy
2005
Completed Phase 2
~4520
Flutamide
FDA approved
Triptorelin
FDA approved
Goserelin
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7010
Bicalutamide
FDA approved
Lidocaine
FDA approved
Nilutamide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 8 years

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
387 Previous Clinical Trials
261,680 Total Patients Enrolled
27 Trials studying Prostate Cancer
53,550 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,085 Previous Clinical Trials
41,140,238 Total Patients Enrolled
537 Trials studying Prostate Cancer
502,394 Patients Enrolled for Prostate Cancer
Brian ChapinPrincipal InvestigatorSouthwest Oncology Group

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients must have received no more than 28 weeks of SST.
Patients must have a testosterone lab documented within 28 days prior to randomization
Patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate
Patients must not have progressed while on SST.
Patients with oligometastatic prostate cancer may receive metastasis directed therapy to up to four sites of disease prior to randomization.
Patients must have a complete physical examination and medical history within 28 days prior to registration.
You must have a PSA documented prior to initiation of SST and within 28 days prior to registration