Clinical trial · Interventional

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

Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer, Phase III

NCT00002651CI-TRIAL-00027020completedPhase 3Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Prostate Cancer	Malignant Prostate Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
bicalutamide	Drug	Bicalutamide	ALIAS
clinical observation	Other	—	UNRESOLVED
goserelin acetate	Drug	Goserelin	ALIAS

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
Consolidation arm I
description
Patients continue CAD therapy comprising goserelin subcutaneously once a month and oral bicalutamide once daily. Treatment continues in the absence of disease progression.
interventionNames
1. Drug: bicalutamide
2. Drug: goserelin acetate
type
EXPERIMENTAL
label
Consolidation arm II
description
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.
interventionNames
1. Drug: bicalutamide
2. Drug: goserelin acetate
3. Other: clinical observation

Primary outcomes (6)

Eligibility

Eligibility (as posted)

Sex: Male
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (12)

BACKGROUNDTangen 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. PMID 22921015
BACKGROUNDHussain 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.
BACKGROUNDHussain 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. PMID 19380444
BACKGROUNDGoldman 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.
BACKGROUNDHussain 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.
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.
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.

Registry

Dates and enrollment

Start: May 1, 1995
Primary completion: Jun 1, 2013
Completion: Jun 1, 2013
First posted: Jan 27, 2003
Last update posted: Apr 17, 2017
Results first posted: Apr 17, 2017
Enrollment: 3,040 (actual)
Lead sponsor: SWOG Cancer Research Network 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
Keywords: adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

Data updated 22 days agoSource updated Apr 17, 2017source: clinicaltrials

Locations

Locations by country (14)

Country	Sites	Recruiting
Canada	14	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.