RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery

Phase 3

Completed

• Conditions: Gastrointestinal Complications; Prostate Cancer; Sexual Dysfunction; Urinary Complications
• Interventions: Procedure: adjuvant therapy; Drug: bicalutamide; Procedure: quality-of-life assessment; Drug: goserelin acetate; Radiation: radiation therapy; Drug: leuprolide acetate

• Registration Number: NCT00541047
• Lead Sponsor: University College, London

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy, such as goserelin, leuprolide, or bicalutamide, may lessen the amount of androgens made by the body. Giving radiation therapy together with androgen deprivation therapy may kill more prostate cancer cells.

PURPOSE: This randomized phase III trial is studying how well giving radiation therapy together with androgen deprivation therapy works in treating patients who have undergone surgery for prostate cancer.

Detailed Description

OBJECTIVES:

* Assess the timing of radiotherapy and the use of hormone therapy in conjunction with post-operative radiotherapy.

* Determine the impact of radiotherapy on general quality of life, sexual function, urinary function, and bowel function.

* Determine the impact of duration of hormone therapy on general quality of life and sexual function.

OUTLINE: This is a multicenter study. Patients requiring immediate radiotherapy (RT) are assigned to arm I; patients do not require immediate RT are assigned to arm II. Patients for whom the need of immediate post-operative radiotherapy are uncertain undergo radiotherapy timing randomization within 3 months after surgery and are randomized to 1 of 2 radiotherapy arms.

* Arm I (immediate RT): Within 2 months after randomization, patients undergo radiotherapy to the prostate bed once a day, 5 days a week, for 4 (20 fractions total) or 6.5 weeks (33 fractions total). They may also undergo radiotherapy to the pelvic lymph nodes once a day, 5 days a week, for 4.5 weeks (23 fractions total) at the investigator's discretion.

* Arm II (early salvage RT in case of PSA failure): Within 2 months of confirmation of post-operative biochemical failure, patients undergo radiotherapy as in arm I.

Patients undergoing immediate RT and patients who eventually need early salvage RT undergo hormone therapy duration randomization before the administration of post-operative radiotherapy. Patients are randomized to 1 of 3 hormone therapy arms.

* Arm III (no hormone therapy): Patients do not receive hormone therapy. They receive post-operative RT alone as described above in arm I or II.

* Arm IV (RT and short-term hormone therapy): Beginning approximately 2 months prior to the start of RT, patients receive hormone therapy for 6 months. Hormone therapy\* may comprise of LHRH agonist (gonadotrophin-releasing hormone analogue \[GnRHa\] \[e.g., goserelin or leuprolide acetate\]) or bicalutamide daily.

* Arm V (RT and long-term hormone therapy): Beginning approximately 2 months prior to the start of RT, patients receive hormone therapy for 24 months. Hormone therapy\* may comprise of LHRH agonist (gonadotrophin-releasing hormone analogue \[GnRHa\] \[e.g., goserelin or leuprolide acetate\]) or bicalutamide daily.

NOTE: \*For Canadian patients, hormonal therapy will consist of LHRH analog (leuprolide acetate) therapy only.

Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed using self-administered questionnaires at baseline and 1, 5, and 10 years after randomization. Health economics information is also collected via patient-administered questionnaires (EQ-5D) at baseline and at 1, 5 and 10 years after randomization.

After completion of study treatment, patients are followed for 7 years.

Study Timeline

• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-05
• Study First Posted: 2007-10-08
• Study Start: 2007-11
• Primary Completion: 2022-07-27
• Study Completion: 2022-07-27
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 4236

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
RADICALS-RT: Early RT	adjuvant therapy	-
RADICALS-RT: Early RT	quality-of-life assessment	-
RADICALS-RT: Early RT	radiation therapy	-
RADICALS-RT: Salvage RT	adjuvant therapy	-
RADICALS-RT: Salvage RT	quality-of-life assessment	-
RADICALS-RT: Salvage RT	radiation therapy	-
RADICALS-HD: Radiotherapy Alone	adjuvant therapy	-
RADICALS-HD: Radiotherapy Alone	radiation therapy	-
RADICALS-HD: Radiotherapy + 6 months	goserelin acetate	-
RADICALS-HD: Radiotherapy + 6 months	leuprolide acetate	-
RADICALS-HD: Radiotherapy + 6 months	adjuvant therapy	-
RADICALS-HD: Radiotherapy + 6 months	radiation therapy	-
RADICALS-HD: Radiotherapy + 24 months	goserelin acetate	-
RADICALS-HD: Radiotherapy + 24 months	leuprolide acetate	-
RADICALS-HD: Radiotherapy + 24 months	adjuvant therapy	-
RADICALS-HD: Radiotherapy + 24 months	radiation therapy	-
RADICALS-HD: Radiotherapy + 6 months	bicalutamide	-
RADICALS-HD: Radiotherapy + 24 months	bicalutamide	-

Primary Outcome Measures

Name	Time	Method
Disease-specific survival (i.e., death due to prostate cancer) (RADICALS-HD)	up 12 years
Freedom from distant metastases (any distance metastases or prostate cancer death) (RADICALS-RT)	up 12 years

Secondary Outcome Measures

Name	Time	Method
Patient reported outcomes - EQ5D	up 12 years
Treatment toxicity	up 12 years
Freedom from treatment failure	up 12 years
Clinical progression-free survival	up 12 years
Overall survival	up 12 years
Freedom from biochemical progression (RADICALS-RT)	up 12 years
Non-protocol hormone therapy	up 12 years

Trial Locations

Locations (58)

British Columbia Cancer Agency - Centre for the Southern Interior; 🇨🇦 Kelowna, British Columbia, Canada

British Columbia Cancer Agency - Vancouver Cancer Centre; 🇨🇦 Vancouver, British Columbia, Canada

London Regional Cancer Program at London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Ottawa Health Research Institute; 🇨🇦 Ottawa, Ontario, Canada

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

William Harvey Hospital; 🇬🇧 Ashford, England, United Kingdom

North Devon District Hospital; 🇬🇧 Barnstaple, England, United Kingdom

Basingstoke and North Hampshire NHS Foundation Trust; 🇬🇧 Basingstoke, England, United Kingdom

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust; 🇬🇧 Birmingham, England, United Kingdom

Royal Bournemouth Hospital; 🇬🇧 Bournemouth, England, United Kingdom

Scroll for more (48 remaining)