Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

1,386

Participants

Timeline

Start Date

January 5, 1999

Primary Completion Date

October 4, 2010

Study Completion Date

January 10, 2013

Conditions
Prostate Cancer
Interventions
DRUG

bicalutamide

"Patients on the IAS arm should receive a minimum of 4 weeks of antiandrogen and a total of 8 months of LHRH analog during each on-treatment interval. The dose and frequency of LHRH treatment will be determined by the drug being administered (Appendix IX). Patients on the IAS arm should not be given an LHRH analog injection at the end of month 8 unless the patient is transferred to continuous treatment as per protocol upon completion of the 8 month intermittent treatment.~Patients may be treated with any commercially available LHRH analog and antiandrogen during or after protocol treatment (Appendix IX). Patients may switch drugs at any time during or after protocol treatment. The dose and schedule of treatment will depend on the agent used. Patients should continue to receive hormone therapy without interruption until hormone resistance has been documented"

DRUG

buserelin

"Patients on the IAS arm should receive a minimum of 4 weeks of antiandrogen and a total of 8 months of LHRH analog during each on-treatment interval. The dose and frequency of LHRH treatment will be determined by the drug being administered (Appendix IX). Patients on the IAS arm should not be given an LHRH analog injection at the end of month 8 unless the patient is transferred to continuous treatment as per protocol upon completion of the 8 month intermittent treatment.~Patients may be treated with any commercially available LHRH analog and antiandrogen during or after protocol treatment (Appendix IX). Patients may switch drugs at any time during or after protocol treatment. The dose and schedule of treatment will depend on the agent used. Patients should continue to receive hormone therapy without interruption until hormone resistance has been documented"

DRUG

cyproterone acetate

"Patients on the IAS arm should receive a minimum of 4 weeks of antiandrogen and a total of 8 months of LHRH analog during each on-treatment interval. The dose and frequency of LHRH treatment will be determined by the drug being administered (Appendix IX). Patients on the IAS arm should not be given an LHRH analog injection at the end of month 8 unless the patient is transferred to continuous treatment as per protocol upon completion of the 8 month intermittent treatment.~Patients may be treated with any commercially available LHRH analog and antiandrogen during or after protocol treatment (Appendix IX). Patients may switch drugs at any time during or after protocol treatment. The dose and schedule of treatment will depend on the agent used. Patients should continue to receive hormone therapy without interruption until hormone resistance has been documented"

DRUG

flutamide

"Patients on the IAS arm should receive a minimum of 4 weeks of antiandrogen and a total of 8 months of LHRH analog during each on-treatment interval. The dose and frequency of LHRH treatment will be determined by the drug being administered (Appendix IX). Patients on the IAS arm should not be given an LHRH analog injection at the end of month 8 unless the patient is transferred to continuous treatment as per protocol upon completion of the 8 month intermittent treatment.~Patients may be treated with any commercially available LHRH analog and antiandrogen during or after protocol treatment (Appendix IX). Patients may switch drugs at any time during or after protocol treatment. The dose and schedule of treatment will depend on the agent used. Patients should continue to receive hormone therapy without interruption until hormone resistance has been documented"

DRUG

goserelin

"Patients on the IAS arm should receive a minimum of 4 weeks of antiandrogen and a total of 8 months of LHRH analog during each on-treatment interval. The dose and frequency of LHRH treatment will be determined by the drug being administered (Appendix IX). Patients on the IAS arm should not be given an LHRH analog injection at the end of month 8 unless the patient is transferred to continuous treatment as per protocol upon completion of the 8 month intermittent treatment.~Patients may be treated with any commercially available LHRH analog and antiandrogen during or after protocol treatment (Appendix IX). Patients may switch drugs at any time during or after protocol treatment. The dose and schedule of treatment will depend on the agent used. Patients should continue to receive hormone therapy without interruption until hormone resistance has been documented"

DRUG

leuprolide acetate

"Patients on the IAS arm should receive a minimum of 4 weeks of antiandrogen and a total of 8 months of LHRH analog during each on-treatment interval. The dose and frequency of LHRH treatment will be determined by the drug being administered (Appendix IX). Patients on the IAS arm should not be given an LHRH analog injection at the end of month 8 unless the patient is transferred to continuous treatment as per protocol upon completion of the 8 month intermittent treatment.~Patients may be treated with any commercially available LHRH analog and antiandrogen during or after protocol treatment (Appendix IX). Patients may switch drugs at any time during or after protocol treatment. The dose and schedule of treatment will depend on the agent used. Patients should continue to receive hormone therapy without interruption until hormone resistance has been documented"

DRUG

nilutamide

"Patients on the IAS arm should receive a minimum of 4 weeks of antiandrogen and a total of 8 months of LHRH analog during each on-treatment interval. The dose and frequency of LHRH treatment will be determined by the drug being administered (Appendix IX). Patients on the IAS arm should not be given an LHRH analog injection at the end of month 8 unless the patient is transferred to continuous treatment as per protocol upon completion of the 8 month intermittent treatment.~Patients may be treated with any commercially available LHRH analog and antiandrogen during or after protocol treatment (Appendix IX). Patients may switch drugs at any time during or after protocol treatment. The dose and schedule of treatment will depend on the agent used. Patients should continue to receive hormone therapy without interruption until hormone resistance has been documented"

Trial Locations (29)

T2N 4N2

Tom Baker Cancer Centre, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

V1Y 5L3

BCCA - Cancer Centre for the Southern Interior, Kelowna

V3V 1Z2

BCCA - Fraser Valley Cancer Centre, Surrey

V5Z 1M9

Clinical Research Unit at Vancouver Coastal, Vancouver

V5Z 4E6

BCCA - Vancouver Cancer Centre, Vancouver

R3E 0V9

CancerCare Manitoba, Winnipeg

E1C 8X3

The Vitalite Health Network - Dr. Leon Richard, Moncton

E2L 4L2

Atlantic Health Sciences Corporation, Saint John

AIB 3V6

Dr. H. Bliss Murphy Cancer Centre, St. John's

B3H 1V7

QEII Health Sciences Center, Halifax

L6R 3J7

William Osler Health Centre, Brampton Memorial, Brampton

P3E 5J1

Northeast Cancer Center Health Sciences, Greater Sudbury

L8V 5C2

Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton

K7L 5P9

Cancer Centre of Southeastern Ontario at Kingston, Kingston

N6A 4L6

London Regional Cancer Program, London

L5M 2N1

Credit Valley Hospital, Mississauga

K1H 8L6

Ottawa Health Research Institute - General Division, Ottawa

L2R 7C6

Niagara Health System, St. Catharines

P7B 6V4

Thunder Bay Regional Health Science Centre, Thunder Bay

M4N 3M5

Odette Cancer Centre, Toronto

M5G 2M9

Univ. Health Network-Princess Margaret Hospital, Toronto

N8W 2X3

Windsor Regional Cancer Centre, Windsor

H2L 4M1

CHUM - Hopital Notre-Dame, Montreal

H2W 1S6

McGill University - Dept. Oncology, Montreal

G1R 2J6

CHUQ-Pavillon Hotel-Dieu de Quebec, Québec

J1H 5N4

Centre hospitalier universitaire de Sherbrooke, Sherbrooke

S4T 7T1

Allan Blair Cancer Centre, Regina

S7N 4H4

Saskatoon Cancer Centre, Saskatoon

Sponsors
All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

SWOG Cancer Research Network

NETWORK

lead

NCIC Clinical Trials Group

NETWORK