Radiation Therapy and Androgen Deprivation Therapy in Treating Patients Who Have Undergone Surgery for Prostate Cancer (RADICALS) - Full Text View

Sponsor:	Medical Research Council
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00541047

Purpose

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.

Condition	Intervention	Phase
Gastrointestinal Complications Prostate Cancer Sexual Dysfunction and Infertility Urinary Complications	Drug: bicalutamide Drug: goserelin Drug: leuprolide acetate Procedure: adjuvant therapy Procedure: quality-of-life assessment Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control
Official Title:	RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery

Resource links provided by NLM:

MedlinePlus related topics: Cancer Infertility Prostate Cancer Surgery

Drug Information available for: Leuprolide Goserelin Leuprolide acetate Bicalutamide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease-specific survival (i.e., death due to prostate cancer) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Freedom from treatment failure [ Designated as safety issue: No ]
Clinical progression-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Non-protocol hormone therapy [ Designated as safety issue: No ]
Treatment toxicity [ Designated as safety issue: Yes ]
Patient reported outcomes [ Designated as safety issue: No ]

Estimated Enrollment:	4000
Study Start Date:	October 2007

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.

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

Diagnosis of nonmetastatic adenocarcinoma of the prostate
Must have undergone radical prostatectomy
Post-operative serum prostate-specific antigen (PSA) < 0.4 ng/mL
No post-operative biochemical failure, defined as EITHER two consecutive rises in PSA and final PSA > 0.1 ng/mL OR three consecutive rises in PSA (for patients undergoing hormone therapy duration randomization)

Exclusion criteria:

Known distant metastases from prostate cancer
PSA > 5 ng/mL at the time of hormone randomization (for patients undergoing hormone therapy duration randomization)

PATIENT CHARACTERISTICS:

No other active malignancy likely to interfere with protocol treatment or follow-up

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

See Disease Characteristics
Co-enrollment to other trials is permitted, providing this does not interfere with the outcome measures
5-α reductase inhibitors, soya, selenium, and vitamin E are acceptable non-trial therapies

Exclusion criteria:

Prior hormone therapy
Bilateral orchidectomy
Prior pelvic radiotherapy
Neoadjuvant treatment
Other concurrent therapies for prostate cancer (e.g., estrogens or cytotoxic chemotherapy) prior to disease progression

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541047

Show 58 Study Locations

Sponsors and Collaborators

Medical Research Council

Investigators

Study Chair:

Christopher Parker, MD

Royal Marsden - Surrey

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000571528, MRC-RADICALS-PR10, ISRCTN40814031, EUDRACT-2006-000205-34, EU-20767, PR13
Study First Received:	October 5, 2007
Last Updated:	October 6, 2009
ClinicalTrials.gov Identifier:	NCT00541047 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

sexual dysfunction and infertility
urinary complications
gastrointestinal complications
adenocarcinoma of the prostate

stage I prostate cancer
stage II prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:

Infertility
Prostatic Diseases
Genital Neoplasms, Male
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Reproductive Control Agents
Hormones
Genital Diseases, Female
Neoplasms by Site
Leuprolide

Therapeutic Uses
Antineoplastic Agents, Hormonal
Goserelin
Genital Diseases, Male
Pharmacologic Actions
Neoplasms
Androgen Antagonists
Fertility Agents, Female
Fertility Agents
Bicalutamide
Prostatic Neoplasms
Androgens

ClinicalTrials.gov processed this record on November 05, 2009