CompletedNCT00002651Updated Apr 17, 2017Results posted

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

A Phase 3 interventional study of bicalutamide and goserelin acetate in Prostate Cancer, sponsored by SWOG Cancer Research Network. Completed at 14 sites in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-17.

Sponsored by SWOG Cancer Research Network · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 3,040
Allocation: Randomized
Ages: 18 Years and older
Sex: Male

Study summary

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.

Read the detailed description

OBJECTIVES:

Primary

Compare the survival of patients with metastatic stage IV prostate cancer responsive to combined androgen-deprivation therapy (CAD) treated with intermittent vs continuous CAD.
Compare the effects of these treatment regimens on impotence, libido, and vitality/fatigue as well as the physical and emotional well-being of these patients.

Secondary

Compare general symptoms, role functioning, global perception of quality of life, and social functioning of patients treated with these regimens.
Assess prostate-specific antigen (PSA) levels after continuous CAD administered before randomization and evaluate PSA changes throughout randomized treatment of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to SWOG performance status (0-1 vs 2), severity of disease (minimal vs extensive), and prior hormonal therapy (neoadjuvant hormonal therapy vs finasteride vs neither).

Induction therapy: Patients receive combined androgen-deprivation (CAD) therapy comprising goserelin subcutaneously once a month and oral bicalutamide once daily for 8 courses (7 months).
Consolidation therapy: Patients are randomized to 1 of 2 consolidation regimens.
- Arm I (continuous CAD therapy): Patients continue CAD therapy as in induction therapy. Treatment continues in the absence of disease progression.
- Arm II (intermittent CAD therapy): 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 induction therapy. Patients whose PSA normalizes after 8 courses return to observation. Patients whose PSA does not normalize after 8 courses continue CAD therapy.

Quality of life is assessed before induction therapy, at 3 months (before consolidation therapy), and then at 9 and 15 months.

Patients are followed every 6-12 months for at least 10 years.

PROJECTED ACCRUAL: Approximately 1,500 patients will be accrued for this study.

Conditions studied

Prostate Cancer

Browse trials for

Prostatic Neoplasms 6,484

Keywords

adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer

In context

Prostatic Neoplasms

6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.

This study's enrollment of 3,040 is above the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

SWOG Cancer Research Network is the lead sponsor of 339 studies on the registry; 37 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Browse SWOG Cancer Research Network studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Male
Accepts healthy volunteers: No

Eligibility criteria

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 3,040 participants (actual)

Study arms

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.
Drug: bicalutamide · Drug: goserelin acetate
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.
Drug: bicalutamide · Drug: goserelin acetate · Other: clinical observation

Interventions

Drugbicalutamide
Given orally
Druggoserelin acetate
Given subcutaneously
Otherclinical observation
Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease.

What researchers measure

Primary outcomes

Overall Survival
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).
Time frame: Up to 15 years
Physical Functioning as Measured by the SF-36
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
Time frame: 3 months
Emotional Functioning as Measured by the SF-36 Mental Health Inventory
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
Time frame: 3 months
Erectile Dysfunction
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.
Time frame: 3 months
High Libido
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.
Time frame: 3 months
Vitality
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.
Time frame: 3 months

Other outcomes

Global Perception of Quality of Life
Time frame: 15 months
Social Functioning
Mean of the change in social functioning from randomization
Time frame: 15 months
Role Functioning
Mean of the change in role functioning from randomization
Time frame: 15 months
General Symptoms
Time frame: 15 months

Results

Posted Apr 17, 2017

Participant flow

Induction

Participant flow — Induction
Milestone	Combined Androgen Deprivation (CAD)	Continuous Hormonal Therapy	Intermittent Hormonal Therapy
Started	3040	0	0
Eligible	2950	0	0
Eligible and began protocol therapy	2950	0	0
Completed	1697	0	0
Not completed	1343	0	0
Withdrew: Adverse event	44	0	0
Withdrew: Refusal unrelated to adverse event	50	0	0
Withdrew: Progression/relapse	274	0	0
Withdrew: Death	62	0	0
Withdrew: Other	823	0	0
Withdrew: Not eligible	90	0	0

Consolidation and Randomization

Participant flow — Consolidation and Randomization
Milestone	Continuous Hormonal Therapy	Intermittent Hormonal Therapy
Started	867	882
Eligible	765	770
Assessable for toxicity	732	702
Completed	29	22
Not completed	838	860
Withdrew: Adverse event	36	14
Withdrew: Refusal unrelated to adverse event	53	75
Withdrew: Progression/relapse	295	298
Withdrew: Death	38	48
Withdrew: Other	314	313
Withdrew: Not eligible	102	112

Outcome measures

PrimaryOverall Survival

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).

Time frame:: Up to 15 years
Reported as:: Median · years

Overall Survival
years	Consolidation Arm I	Consolidation Arm II
Overall Survival	5.8 (5.3 to 6.4)	5.1 (4.8 to 5.5)

Statistical analysis

Consolidation Arm I vs Consolidation Arm II · Regression, Cox · p = 0.15 · Hazard ratio (hr): 1.10 · 90% CI 0.99 to 1.23

PrimaryPhysical Functioning as Measured by the SF-36

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

Time frame:: 3 months
Reported as:: Mean · units on a scale

Physical Functioning as Measured by the SF-36
units on a scale	Continuous Hormonal Therapy	Intermittent Hormonal Therapy
Physical Functioning as Measured by the SF-36	-1.74 ± 0.7366	0.09 ± 0.8084

Statistical analysis

Continuous Hormonal Therapy vs Intermittent Hormonal Therapy · t-test, 2 sided · p = 0.09 (The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).) · Mean difference (net): 1.83 · 95% CI -0.31 to 3.97

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

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

Time frame:: 3 months
Reported as:: Mean · units on a scale

Emotional Functioning as Measured by the SF-36 Mental Health Inventory
units on a scale	Continuous Hormonal Therapy	Intermittent Hormonal Therapy
Emotional Functioning as Measured by the SF-36 Mental Health Inventory	-0.95 ± 0.6804	1.92 ± 0.7241

Statistical analysis

Continuous Hormonal Therapy vs Intermittent Hormonal Therapy · t-test, 2 sided · p = 0.003 (The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).) · Mean difference (net): 2.88 · 95% CI 1.00 to 4.76

PrimaryErectile Dysfunction

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.

Time frame:: 3 months
Reported as:: Number · percentage of participants

Erectile Dysfunction
percentage of participants	Continuous Hormonal Therapy	Intermittent Hormonal Therapy
Erectile Dysfunction	2	-7

Statistical analysis

Continuous Hormonal Therapy vs Intermittent Hormonal Therapy · t-test, 2 sided · p = <0.001 (The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).) · Mean difference (net): -10 · 95% CI -14 to -5

PrimaryHigh Libido

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.

Time frame:: 3 months
Reported as:: Number · percentage of participants

High Libido
percentage of participants	Continuous Hormonal Therapy	Intermittent Hormonal Therapy
High Libido	-2	16

Statistical analysis

Continuous Hormonal Therapy vs Intermittent Hormonal Therapy · t-test, 2 sided · p = 0.04 (The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).) · Mean difference (net): 18 · 95% CI 1 to 36

PrimaryVitality

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.

Time frame:: 3 months
Reported as:: Mean · units on a scale

Vitality
units on a scale	Continuous Hormonal Therapy	Intermittent Hormonal Therapy
Vitality	-1.42 ± 0.7379	-0.11 ± 0.8154

Statistical analysis

Continuous Hormonal Therapy vs Intermittent Hormonal Therapy · t-test, 2 sided · p = 0.23 (The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).) · Mean difference (net): 1.32 · 95% CI -0.83 to 3.46

Other pre-specifiedGlobal Perception of Quality of Life

Time frame:: 15 months

Results for this outcome have not been posted.

Other pre-specifiedSocial Functioning

Mean of the change in social functioning from randomization

Time frame:: 15 months

Results for this outcome have not been posted.

Other pre-specifiedRole Functioning

Mean of the change in role functioning from randomization

Time frame:: 15 months

Results for this outcome have not been posted.

Other pre-specifiedGeneral Symptoms

Time frame:: 15 months

Results for this outcome have not been posted.

Adverse events

Collected over Up to 10 years after registration to Induction. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Continuous Hormonal Therapy	—	19/732 (2.6%)	665/732 (90.8%)
Intermittent Hormonal Therapy	—	10/702 (1.4%)	609/702 (86.8%)

Most frequent serious events

Most frequent serious events
Event	Continuous Hormonal Therapy	Intermittent Hormonal Therapy
Cardiac ischemia/infarctionCardiac disorders	6/732	2/702
Flu-like symptoms-otherGeneral disorders	5/732	3/702
Lung-otherRespiratory, thoracic and mediastinal disorders	0/732	2/702
Cardiovascular-otherCardiac disorders	2/732	1/702
LVEF decrease/CHFCardiac disorders	1/732	1/702
Cerebrovascular ischemiaNervous system disorders	1/732	1/702
Second primaryNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/732	0/702
Pleural effusionsRespiratory, thoracic and mediastinal disorders	1/732	0/702
Hemorrhage-otherVascular disorders	1/732	0/702
Thrombosis/embolismVascular disorders	1/732	0/702

Most frequent other events

Showing 10 of 30

Most frequent other events
Event	Continuous Hormonal Therapy	Intermittent Hormonal Therapy
Hot flashesVascular disorders	511/732	440/702
Fatigue/malaise/lethargyGeneral disorders	381/732	364/702
Erectile impotenceReproductive system and breast disorders	304/732	256/702
Bone painMusculoskeletal and connective tissue disorders	239/732	272/702
Libido lossPsychiatric disorders	262/732	226/702
SweatingSkin and subcutaneous tissue disorders	245/732	176/702
GynecomastiaReproductive system and breast disorders	181/732	158/702
Urinary frequency/urgencyRenal and urinary disorders	141/732	147/702
InsomniaPsychiatric disorders	141/732	123/702
Pain-otherGeneral disorders	140/732	131/702

Baseline characteristics

Randomized and eligible patients (After induction, Patients with stable or declining PSA levels of 4.0 ng per milliliter or lower at months 6 and 7 were eligible for randomization).

Age, Continuous
Age, Continuous(years)	Continuous Hormonal Therapy	Intermittent Hormonal Therapy	Total
Median	70 (39 to 92)	70 (39 to 97)	70 (39 to 97)

Sex: Female, Male
Sex: Female, Male(Participants)	Continuous Hormonal Therapy	Intermittent Hormonal Therapy	Total
Female	0	0	0
Male	765	770	1535

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Continuous Hormonal Therapy	Intermittent Hormonal Therapy	Total
Hispanic or Latino	17	23	40
Not Hispanic or Latino	571	564	1135
Unknown or Not Reported	177	183	360

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Continuous Hormonal Therapy	Intermittent Hormonal Therapy	Total
American Indian or Alaska Native	2	4	6
Asian	5	8	13
Native Hawaiian or Other Pacific Islander	2	0	2
Black or African American	93	94	187
White	507	519	1026
More than one race	2	1	3
Unknown or Not Reported	154	144	298

Study locations

14 sites

Tom Baker Cancer Centre - Calgary
Calgary, Alberta T2N 4N2, Canada
Cross Cancer Institute at University of Alberta
Edmonton, Alberta T6G 1Z2, Canada
University of British Columbia
Vancouver, British Columbia V5Z 1M9, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia B3H 1V7, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario K7L 5P9, Canada
London Regional Cancer Program at London Health Sciences Centre
London, Ontario N6A 4L6, Canada
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario K1H 8L6, Canada
Odette Cancer Centre at Sunnybrook
Toronto, Ontario M4N 3M5, Canada
Princess Margaret Hospital
Toronto, Ontario M5G 2M9, Canada
Hopital Notre-Dame du CHUM
Montreal, Quebec H2L 4M1, Canada
McGill Cancer Centre at McGill University
Montreal, Quebec H2W 1S6, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec G1R 2J6, Canada
CHUS-Hopital Fleurimont
Sherbrooke, Quebec J1H 5N4, Canada
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan S7N 4H4, Canada

References and documents

Publications

Tangen CM, Hussain MH, Higano CS, Eisenberger MA, Small EJ, Wilding G, Donnelly BJ, Schelhammer PF, Crawford ED, Vogelzang NJ, Powell IJ, Thompson IM Jr. Improved overall survival trends of men with newly diagnosed M1 prostate cancer: a SWOG phase III trial experience (S8494, S8894 and S9346). J Urol. 2012 Oct;188(4):1164-9. doi: 10.1016/j.juro.2012.06.046. Epub 2012 Aug 22. PubMed 22921015 ↗
Hussain M, Tangen CM, Higano CS, et al.: Improved overall survival (OS) of patients (pts) with new metastatic prostate cancer (pca): better efficacy or stage migration? Data from SWOG: S9346 and 8894. [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-30, 2010.
Hussain M, Goldman B, Tangen C, Higano CS, Petrylak DP, Wilding G, Akdas AM, Small EJ, Donnelly BJ, Sundram SK, Burch PA, Dipaola RS, Crawford ED. Prostate-specific antigen progression predicts overall survival in patients with metastatic prostate cancer: data from Southwest Oncology Group Trials 9346 (Intergroup Study 0162) and 9916. J Clin Oncol. 2009 May 20;27(15):2450-6. doi: 10.1200/JCO.2008.19.9810. Epub 2009 Apr 20. PubMed 19380444 ↗
Goldman B, Hussain M, Tangen C, et al.: Prostate-specific antigen progression (PSA-P) as a predictor of overall survival (OS) in patients (pts) with metastatic prostate cancer (PC): data from S9346 and S9916. [Abstract] American Society of Clinical Oncology 2008 Genitourinary Cancers Symposium, Feb 14-16, 2008, San Francisco, CA. A-165, 2008.
Hussain MH, Goldman B, Tangen CM, et al.: Use of prostate-specific antigen progression (PSA-P) to predict overall survival (OS) in patients (pts) with metastatic prostate cancer (PC): data from S9346 and S9916. [Abstract] J Clin Oncol 26 (Suppl 15): A-5015, 2008.
Hussain 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.
Moinpour 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.
Hussain 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. PubMed 16921051 ↗
Tangen 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.
Hershman 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. PubMed 26720308 ↗
Eggener 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. PubMed 25087673 ↗
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. Intermittent versus continuous androgen deprivation in prostate cancer. N Engl J Med. 2013 Apr 4;368(14):1314-25. doi: 10.1056/NEJMoa1212299. PubMed 23550669 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 1995, a primary completion of Jun 2013 and a completion of Jun 2013. It does not say whether these dates are actual or estimated.

Results were first posted in Apr 2017, 3 years 10 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 1, 1999
First posted: Jan 27, 2003
Start: May 1995
Primary completionActual: Jun 2013
CompletionActual: Jun 2013
Results first posted: Apr 17, 2017
Last update: Apr 17, 2017

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00002651
Lead sponsor: SWOG Cancer Research Network
Collaborators: National Cancer Institute (NCI), NCIC Clinical Trials Group, Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, European Organisation for Research and Treatment of Cancer - EORTC
Responsible party: Sponsor
First posted: Jan 27, 2003
Start date: May 1995
Primary completion: Jun 2013
Completion: Jun 2013
Results posted: Apr 17, 2017
Last update: Apr 17, 2017

Study contacts

Maha Hadi A. Hussain, MD

study chair · University of Michigan Rogel Cancer Center

Bryan J. Donnelly, MD, FRCSC, MSC

study chair · Tom Baker Cancer Centre - Calgary

Eric J. Small, MD

study chair · University of California, San Francisco

George Wilding, MD

study chair · University of Wisconsin, Madison

Atif Akdas, MD

study chair · Marmara University Hospital

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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