Androgen Suppression and Radiation With/Out Docetaxel in High-Risk Localized Prostate Cancer

NCT00651326 | Terminated Phase 3 DMC

• 3 other identifiers: PR12CAN-NCIC-PR12CDR0000589247
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 13

Brief Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, leuprolide, buserelin, and goserelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving androgen suppression therapy together with radiation therapy is more effective with or without docetaxel in treating prostate cancer. PURPOSE: This randomized phase III trial is studying androgen suppression therapy, radiation therapy, and docetaxel to see how well they work compared with androgen suppression therapy and radiation therapy in treating patients with high-risk localized prostate cancer. CLOSURE: This trial closed to further accrual in November 2009. The study endpoints will not be reached.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

Secondary Outcomes (9)

• Overall survival

• Time to biochemical disease progression

• Time to local disease progression

• Time to distant disease progression

• Time to next anti-cancer therapy

Study Arms (2)

Antiandrogen; LHRH; Docetaxel, Radiation Therapy

ACTIVE COMPARATOR

Antiandrogen (Flutamide or Bicalutamide) LHRH agonist (Eligard) Docetaxel

Drug: bicalutamide; Drug: buserelin; Drug: flutamide; Drug: goserelin; Drug: leuprolide acetate; Procedure: neoadjuvant therapy; Procedure: quality-of-life assessment; Radiation: radiation therapy; Drug: Docetaxel

Antiandrogen; LHRH; Radiation Therapy

ACTIVE COMPARATOR

Antiandrogen (Flutamide or Bicalutamide) LHRH agonist (Eligard)

Drug: bicalutamide; Drug: buserelin; Drug: flutamide; Drug: goserelin; Drug: leuprolide acetate; Procedure: neoadjuvant therapy; Procedure: quality-of-life assessment; Radiation: radiation therapy

Interventions

bicalutamide DRUG

Antiandrogen; LHRH; Docetaxel, Radiation Therapy; Antiandrogen; LHRH; Radiation Therapy

buserelin DRUG

Antiandrogen; LHRH; Docetaxel, Radiation Therapy; Antiandrogen; LHRH; Radiation Therapy

flutamide DRUG

Antiandrogen; LHRH; Docetaxel, Radiation Therapy; Antiandrogen; LHRH; Radiation Therapy

goserelin DRUG

Antiandrogen; LHRH; Docetaxel, Radiation Therapy; Antiandrogen; LHRH; Radiation Therapy

leuprolide acetate DRUG

Antiandrogen; LHRH; Docetaxel, Radiation Therapy; Antiandrogen; LHRH; Radiation Therapy

neoadjuvant therapy PROCEDURE

Antiandrogen; LHRH; Docetaxel, Radiation Therapy; Antiandrogen; LHRH; Radiation Therapy

quality-of-life assessment PROCEDURE

Antiandrogen; LHRH; Docetaxel, Radiation Therapy; Antiandrogen; LHRH; Radiation Therapy

radiation therapy RADIATION

46 Gy in 23 fractions over \< 5 weeks. Boost: 24-28 Gy in 12-14 fractions over \< 3 weeks

Antiandrogen; LHRH; Docetaxel, Radiation Therapy; Antiandrogen; LHRH; Radiation Therapy

Docetaxel DRUG

Antiandrogen; LHRH; Docetaxel, Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Localized (N0, M0) disease * No small cell or transitional cell carcinoma in the biopsy specimen * Considered to be at high risk for recurrence based on the presence of at least one of the following adverse prognostic features: * T stage ≥ 3a * Gleason score ≥ 8 * Baseline prostate-specific antigen (PSA) \> 20 ng/mL * Deemed to be an appropriate candidate for chemotherapy, as assessed by a medical oncologist * Negative pelvic and para-aortic lymph nodes on CT scan or MRI of the abdomen and pelvis * Any lymph node appearing ≥ 1.5 cm on CT scan or MRI must be histologically negative by either needle aspirate or lymph node dissection * No metastases by chest x-ray and bone scan PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 10.0 g/dL * AST and/or ALT ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN * Total bilirubin normal * Serum creatinine ≤ 1.5 times ULN * Able (i.e., sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French * Fertile patients must use effective contraception * No history of other malignancies, except adequately treated nonmelanoma skin cancer or other curatively treated solid tumor with no evidence of disease for \> 5 years * No serious non-malignant disease resulting in a life expectancy of \< 10 years * No known hypersensitivity to any study medications * No existing peripheral neuropathy ≥ grade 2 * No bilateral hip replacement prostheses * No contraindication to pelvic radiotherapy including, but not limited to, inflammatory bowel disease or severe bladder irritability * No medical condition that would contraindicate the study treatment regimen, including severe respiratory insufficiency, uncontrolled diabetes, or severe hypertension * No other serious illness or psychiatric or medical condition that would preclude management of the patient according to the study, including active uncontrolled infection or significant cardiac dysfunction PRIOR CONCURRENT THERAPY: * Prior androgen suppression therapy allowed provided it was initiated no more than 4 weeks prior to study entry * At least 4 weeks since prior 5-alpha-reductase inhibitors (e.g., finasteride) for benign prostatic hypertrophy * No prior cytotoxic anticancer therapy * No prior chemotherapy for carcinoma of the prostate * No prior surgical treatment for carcinoma of the prostate, except transurethral resection or bilateral orchiectomy * No prior pelvic radiotherapy * No concurrent nilutamide * No other concurrent investigational drugs * No other concurrent anticancer therapy (cytotoxic therapy, biologic/immunotherapy, or radiotherapy)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (13)

Tom Baker Cancer Centre

Calgary, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, T6G 1Z2, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, L8V 5C2, Canada

Location

BCCA - Cancer Centre for the Southern Interior

Kelowna, V1Y 5L3, Canada

Location

London Regional Cancer Program

London, N6A 4L6, Canada

Location

Credit Valley Hospital

Mississauga, L5M 2N1, Canada

Location

McGill University - Dept. Oncology

Montreal, H2W 1S6, Canada

Location

Lakeridge Health Oshawa

Oshawa, L1G 2B9, Canada

Location

Ottawa Health Research Institute - General Division

Ottawa, K1H 8L6, Canada

Location

Saskatoon Cancer Centre

Saskatoon, S7N 4H4, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, M5G 2M9, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, V5Z 4E6, Canada

Location

CancerCare Manitoba

Winnipeg, R3E 0V9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamide; Buserelin; Flutamide; Goserelin; Leuprolide; Neoadjuvant Therapy; Radiotherapy; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Combined Modality Therapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Michael R. McKenzie, MD, FRCPC

  British Columbia Cancer Agency

  STUDY CHAIR

• Kim N. Chi, MD

  British Columbia Cancer Agency

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 2, 2008
• Study Start: June 2, 2008
• Primary Completion: May 14, 2010
• Study Completion: January 18, 2011
• Last Updated: August 4, 2023

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (13)