Trial · Interventional

CompletedPhase 3Results postedRegistry data

SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer

NCTNCT00002651Other idCDR0000064184Other idSWOG-9346Other idCAN-NCIC-PR8Other idCALGB-9594

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 3,040 participants (actual)
Sponsor: SWOG Cancer Research Network · Network
Design: Randomized · Open label (no masking)
Countries: 1 country
Canada
Start: May 1995
Primary completion: Jun 2013
Completion: Jun 2013
First posted: 27 Jan 2003 (estimated)
Last update posted: 17 Apr 2017
Conditions: Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

1995200020052010

Ph 3
SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer
NCT00002651
May 1995 to Jun 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy may be effective treatment for prostate cancer. It is not yet known which regimen of hormone therapy is most effective for stage IV prostate cancer. PURPOSE: This randomized phase III trial is studying two different regimens of hormone therapy and comparing how well they work in treating men with stage IV prostate cancer.

Interventions

bicalutamideDrug
goserelin acetateDrug
clinical observationOther

Arms2

Active comparator
Consolidation arm I
Patients continue CAD therapy comprising goserelin subcutaneously once a month and oral bicalutamide once daily. Treatment continues in the absence of disease progression.
Experimental
Consolidation arm II
Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy as in consolidation arm I. Patients whose PSA normalizes after 8 courses return to observation. Patients whose PSA does not normalize after 8 courses continue CAD therapy.

Primary outcomes6

Outcomes the sponsor listed as primary.

Overall Survival
Time frame · Up to 15 years
Registry description
Non-inferiority test to determine if intermittent combined androgen deprivation (CAD) overall survival is not substantially worse than continuous CAD overall survival. Specifically, the trial is designed for a one-sided test of the hypothesis that the hazard ratio of intermittent CAD to continuous CAD is 1.2. The assumptions used to compute the trial size are an overall type I error rate of 0.05 and a type II error of 0.10 (power = 0.9).
Physical Functioning as Measured by the SF-36
Time frame · 3 months
Registry description
This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. Change from Baseline in SF-36 Score at 3 Months
Emotional Functioning as Measured by the SF-36 Mental Health Inventory
Time frame · 3 months
Registry description
This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. Change from Baseline in SF-36 Score at 3 Months
Erectile Dysfunction
Time frame · 3 months
Registry description
This outcome was assessed by having patients report whether they had erectile dysfunction (a score of 1) or no erectile dysfunction (a score of 0). This analysis looks at change from Baseline to 3 Months.
High Libido
Time frame · 3 months
Registry description
This outcome was assessed by having patients report whether their interest in sexual activities was very high, high, or moderate (a score of 1) or low or very low (a score of 0). This outcome measure is reporting a change from baseline in the percentage of participants with High Libido at 3 months. "High Libido" is defined as very high, high or moderate interest in sexual activities.
Vitality
Time frame · 3 months
Registry description
This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. This analysis looks at mean change from Baseline score to 3 Months.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Up to 15 years

Overall Survival

Group	Value (years)
Consolidation Arm I	5.8
Consolidation Arm II	5.1

Primary outcomeMean· 3 months

Physical Functioning as Measured by the SF-36

Group	Value (units on a scale)	Spread
Continuous Hormonal Therapy	-1.74	0.7366
Intermittent Hormonal Therapy	0.09	0.8084

Primary outcomeMean· 3 months

Emotional Functioning as Measured by the SF-36 Mental Health Inventory

Group	Value (units on a scale)	Spread
Continuous Hormonal Therapy	-0.95	0.6804
Intermittent Hormonal Therapy	1.92	0.7241

Primary outcomeNumber· 3 months

Erectile Dysfunction

Group	Value (percentage of participants)
Continuous Hormonal Therapy	2
Intermittent Hormonal Therapy	-7

Primary outcomeNumber· 3 months

High Libido

Group	Value (percentage of participants)
Continuous Hormonal Therapy	-2
Intermittent Hormonal Therapy	16

Primary outcomeMean· 3 months

Vitality

Group	Value (units on a scale)	Spread
Continuous Hormonal Therapy	-1.42	0.7379
Intermittent Hormonal Therapy	-0.11	0.8154

Secondary and other outcome results(2)

Other pre specified outcome· 15 months

Global Perception of Quality of Life

Group	Value

Other pre specified outcome· 15 months

Social Functioning

Group	Value

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Continuous Hormonal TherapyPatients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease	–	19 / 732	665 / 732
Intermittent Hormonal TherapyPatients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).	–	10 / 702	609 / 702

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

ResultHussain M, Tangen CM, Higano CS, et al.: Intermittent (IAD) versus continuous androgen deprivation (CAD) in hormone sensitive metastatic prostate cancer (HSM1PC) patients (pts): results of S9346 (INT-0162), an international phase III trial. [Abstract] J Clin Oncol 30 (Suppl 15): A-4, 2012.
ResultMoinpour C, Berry DL, Ely B, et al.: Preliminary quality-of-life outcomes for SWOG-9346: Intermittent androgen deprivation in patients with hormone-sensitive metastatic prostate cancer (HSM1PC)-phase III. [Abstract] J Clin Oncol 30 (Suppl 15): A-4571, 2012.
ResultHussain M, Tangen CM, Higano C, Schelhammer PF, Faulkner J, Crawford ED, Wilding G, Akdas A, Small EJ, Donnelly B, MacVicar G, Raghavan D; Southwest Oncology Group Trial 9346 (INT-0162). Absolute prostate-specific antigen value after androgen deprivation is a strong independent predictor of survival in new metastatic prostate cancer: data from Southwest Oncology Group Trial 9346 (INT-0162). J Clin Oncol. 2006 Aug 20;24(24):3984-90. doi: 10.1200/JCO.2006.06.4246. PMID 16921051
ResultTangen CM, Hussain M, Wilding G, et al.: Determinants of prostate specific antigen (PSA) normalization in prostate cancer (PCa) patients (pts) treated with androgen deprivation (AD) on Southwest Oncology Group (SWOG) study 9346 (INT-0162). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1591, 2003.
DerivedHershman DL, Unger JM, Wright JD, Ramsey S, Till C, Tangen CM, Barlow WE, Blanke C, Thompson IM, Hussain M. Adverse Health Events Following Intermittent and Continuous Androgen Deprivation in Patients With Metastatic Prostate Cancer. JAMA Oncol. 2016 Apr;2(4):453-61. doi: 10.1001/jamaoncol.2015.4655. PMID 26720308
DerivedEggener S. Commentary on "Intermittent versus continuous androgen deprivation in prostate cancer." Hussain M, Tangen CM, Berry DL, Higano CS, Crawford ED, Liu G, Wilding G, Prescott S, Kanaga Sundaram S, Small EJ, Dawson NA, Donnelly BJ, Venner PM, Vaishampayan UN, Schellhammer PF, Quinn DI, Raghavan D, Ely B, Moinpour CM, Vogelzang NJ, Thompson IM Jr, University of Michigan, Division of Hematology/Oncology, Ann Arbor, MI. N Engl J Med 2013; 368(14):1314-25. doi: 10.1056/NEJMoa1212299. Urol Oncol. 2014 Aug;32(6):936-7. doi: 10.1016/j.urolonc.2014.01.009. PMID 25087673
DerivedHussain M, Tangen CM, Berry DL, Higano CS, Crawford ED, Liu G, Wilding G, Prescott S, Kanaga Sundaram S, Small EJ, Dawson NA, Donnelly BJ, Venner PM, Vaishampayan UN, Schellhammer PF, Quinn DI, Raghavan D, Ely B, Moinpour CM, Vogelzang NJ, Thompson IM Jr. Intermittent versus continuous androgen deprivation in prostate cancer. N Engl J Med. 2013 Apr 4;368(14):1314-25. doi: 10.1056/NEJMoa1212299. PMID 23550669

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the prostate * Metastatic stage IV (stage D2) * Any number of bone metastases by bone scan allowed * Unequivocal visceral organ metastases (liver, brain, or lung) allowed * No suspected second primary tumors unless metastases are histologically confirmed, including special stains (e.g., prostate specific antigen \[PSA\] and prostatic alkaline phosphatase \[PAP\]) * For entry into late induction therapy: * No more than 1 month from the beginning of antiandrogen therapy to the beginning of luteinizing hormone-releasing hormone (LHRH) agonist therapy * No more than 6 months since initiation of current combined androgen-deprivation therapy (LHRH agonist and antiandrogen) * The effectiveness of the current depot LHRH agonist would not extend beyond 8 months after initiation of combined androgen therapy * PSA at least 5 ng/mL * No acute spinal cord compression PATIENT CHARACTERISTICS: Age: * Adult Performance status: * SWOG 0-2 Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * Recovered from any major infection * No active medical illness that would preclude study or limit survival * No other malignancy within the past 5 years except: * Adequately treated basal cell or squamous cell skin cancer * Adequately treated carcinoma in situ of the bladder * Adequately treated other superficial cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent biological response modifier therapy Chemotherapy: * No concurrent chemotherapy Endocrine therapy: * See Disease Characteristics * More than 1 year since any prior neoadjuvant or adjuvant hormonal therapy for a duration of no more than 4 months * Single or combination therapy allowed * More than 1 year since prior finasteride for prostate cancer for a duration of no more than 9 months (less than 6 months for benign prostatic hypertrophy) * Prior or concurrent megestrol for hot flashes allowed * No other concurrent hormonal therapy Radiotherapy: * No concurrent radiotherapy other than palliation of painful bone metastases Surgery: * No prior bilateral orchiectomy * Recovered from any prior major surgery

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