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NCT00002633 · CITED IN SOURCE DOCUMENTS

Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2020-04-03

RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer. PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Histologically proven locally advanced adenocarcinoma of the prostate, defined as 1 of the following: * T3-4, N0 or NX, M0 * T2, PSA greater than 40 µg/L * T2, PSA greater than 20 µg/L AND Gleason score at least 8 * Diagnosis made within the past 6 months * Gleason score and PSA known * Pelvic lymph nodes must be clinically negative * Lymph nodes no more than 1.5 cm in greatest diameter by CT scan or MRI of the pelvis * Negative needle aspirate required for any lymph node more than 1.5 cm * If a lymph node dissection was performed, it must be histologically negative * No small cell or transitional cell carcinoma by biopsy * No bony metastases by bone scan PATIENT CHARACTERISTICS: Age: * Under 80 Performance status: * ECOG 0-2 Life expectancy: * At least 5 years excluding malignancy Hematopoietic: * Hemoglobin at least 10.0 g/dL * WBC at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 2 times upper limit of normal (ULN) * SGOT and SGPT less than 2 times ULN * Alkaline phosphatase less than 2 times ULN * No history of chronic liver disease Renal: * Creatinine less than 2 times ULN Other: * No contraindication to wide-field pelvic irradiation (e.g., inflammatory bowel disease or severe bladder irritability) * No other malignancy within the past 5 years except nonmelanoma skin cancer * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Prior hormonal therapy within the past 12 weeks allowed provided the following conditions are met: * Negative bone scan before beginning any hormonal therapy * Extracapsular extension remains palpable on rectal re-exam * Baseline PSA known before beginning any hormonal therapy * At least 4-6 weeks since prior 5-alpha-reductase inhibitor (e.g., finasteride) for benign prostatic hypertrophy Radiotherapy: * No prior pelvic irradiation Surgery: * No prior radical prostatectomy * Prior transurethral resection of the prostate allowed Other: * No prior cytotoxic anticancer therapy * No other prior treatment for prostate cancer * No other concurrent anticancer therapy unless documented disease progression
healthy Volunteers
false
maximum Age
79 Years
sex
MALE
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Drug: bicalutamide
    2. Drug: buserelin
    3. Drug: flutamide
    4. Drug: goserelin
    5. Drug: leuprolide acetate
    6. Drug: nilutamide
    7. Procedure: orchiectomy
    label
    Total Androgen Blockade
    type
    ACTIVE_COMPARATOR
  2. intervention Names
    1. Drug: bicalutamide
    2. Drug: buserelin
    3. Drug: flutamide
    4. Drug: goserelin
    5. Drug: leuprolide acetate
    6. Drug: nilutamide
    7. Procedure: orchiectomy
    8. Radiation: radiation therapy
    label
    Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Total Androgen Blockade
    2. Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation
    description
    Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk
    name
    bicalutamide
    type
    DRUG
  2. arm Group Labels
    1. Total Androgen Blockade
    2. Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation
    description
    Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk
    name
    buserelin
    type
    DRUG
  3. arm Group Labels
    1. Total Androgen Blockade
    2. Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation
    description
    Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk
    name
    flutamide
    type
    DRUG
  4. arm Group Labels
    1. Total Androgen Blockade
    2. Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation
    description
    Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk
    name
    goserelin
    type
    DRUG
  5. arm Group Labels
    1. Total Androgen Blockade
    2. Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation
    description
    Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk
    name
    leuprolide acetate
    type
    DRUG
  6. arm Group Labels
    1. Total Androgen Blockade
    2. Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation
    description
    Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk
    name
    nilutamide
    type
    DRUG
  7. arm Group Labels
    1. Total Androgen Blockade
    2. Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation
    description
    Optional orchiectomy
    name
    orchiectomy
    type
    PROCEDURE
  8. arm Group Labels
    1. Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation
    description
    Radical Radiation Therapy - (65-69 Gy; 35-37 treatments)
    name
    radiation therapy
    type
    RADIATION
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
361
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Overall survival
    time Frame
    10 years
secondary Outcomes
  1. measure
    Disease specific survival
    time Frame
    10 years
  2. measure
    Time to disease progression
    time Frame
    10 years
  3. measure
    Symptomatic local control measured by surgical intervention rate
    time Frame
    10 years
  4. measure
    Quality of life assessed by EORTC-QLQ-C30 + 3 and a trial-specific checklist (PR17) or the FACT-P questionnaire
    time Frame
    10 years
Full study description
brief Summary
RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer. PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.
detailed Description
OBJECTIVES: * Compare the overall survival, disease specific survival, and time to progression in patients with locally advanced adenocarcinoma of the prostate treated with total androgen suppression with or without pelvic irradiation. * Compare the symptomatic control as measured by the rates of surgical interventions needed for control of local disease (e.g., transurethral resections, stent insertions, nephrostomies, and colostomies) in patients treated with these regimens. * Compare the quality of life of patients treated with these regimens. * Compare the sensitivity of the EORTC-QLQ-C30+3 and a trial-specific checklist (PR17) with the FACT-P questionnaire in measuring changes in quality of life of patients treated with these regimens. OUTLINE: This a randomized, multicenter study. Patients are stratified according to center, initial PSA level (less than 20 vs 20-50 vs greater than 50 ng/mL), method of node staging (clinical \[no CT scan\] vs radiological \[CT scan negative\] vs surgical), Gleason score (less than 8 vs 8-10), prior hormonal therapy (excluding orchiectomy) (yes vs no), and choice of hormonal therapy (bilateral orchiectomy with or without antiandrogen vs luteinizing hormone-releasing hormone \[LHRH\] with antiandrogen). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive antiandrogen therapy comprising oral flutamide every 8 hours, oral nilutamide every 8 hours for 1 month and then once daily, or oral bicalutamide once daily. Patients also choose to undergo bilateral orchiectomy or LHRH agonist therapy comprising goserelin subcutaneously (SC) every 4 weeks (short-acting formulation) or every 3 months (long-acting formulation), leuprolide intramuscularly every 4 weeks (short-acting formulation) or every 3 months (long-acting formulation), or buserelin SC every 8 weeks or every 12 weeks. Patients choosing orchiectomy may receive an antiandrogen for at least 6 weeks before surgery to counter any flare phenomenon and may continue the antiandrogen after surgery (at the physician's discretion). * Arm II: Patients undergo total androgen ablation as in arm I. Patients with node-negative dissection undergo radiotherapy 5 days a week for 6.5-7 weeks. All other patients undergo radiotherapy 5 days a week for 5 weeks, followed by boost radiotherapy 5 days a week for 2-2.4 weeks. Hormonal therapy on both arms continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, on the last day of radiotherapy, at 6 months, and then every 6 months thereafter. Patients are followed at 1, 2, and 6 months and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 1,200 patients will be accrued for this study within 7.5 years.
Source references
references
  1. citation
    Warde P, Mason M, Ding K, Kirkbride P, Brundage M, Cowan R, Gospodarowicz M, Sanders K, Kostashuk E, Swanson G, Barber J, Hiltz A, Parmar MK, Sathya J, Anderson J, Hayter C, Hetherington J, Sydes MR, Parulekar W; NCIC CTG PR.3/MRC UK PR07 investigators. Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial. Lancet. 2011 Dec 17;378(9809):2104-11. doi: 10.1016/S0140-6736(11)61095-7. Epub 2011 Nov 2.
    pmid
    22056152
    type
    RESULT
  2. citation
    Brundage M, Sydes MR, Parulekar WR, Warde P, Cowan R, Bezjak A, Kirkbride P, Parliament M, Moynihan C, Bahary JP, Parmar MK, Sanders K, Chen BE, Mason MD. Impact of Radiotherapy When Added to Androgen-Deprivation Therapy for Locally Advanced Prostate Cancer: Long-Term Quality-of-Life Outcomes From the NCIC CTG PR3/MRC PR07 Randomized Trial. J Clin Oncol. 2015 Jul 1;33(19):2151-7. doi: 10.1200/JCO.2014.57.8724. Epub 2015 May 26.
    pmid
    26014295
    type
    DERIVED
  3. citation
    Mason MD, Parulekar WR, Sydes MR, Brundage M, Kirkbride P, Gospodarowicz M, Cowan R, Kostashuk EC, Anderson J, Swanson G, Parmar MK, Hayter C, Jovic G, Hiltz A, Hetherington J, Sathya J, Barber JB, McKenzie M, El-Sharkawi S, Souhami L, Hardman PD, Chen BE, Warde P. Final Report of the Intergroup Randomized Study of Combined Androgen-Deprivation Therapy Plus Radiotherapy Versus Androgen-Deprivation Therapy Alone in Locally Advanced Prostate Cancer. J Clin Oncol. 2015 Jul 1;33(19):2143-50. doi: 10.1200/JCO.2014.57.7510. Epub 2015 Feb 17.
    pmid
    25691677
    type
    DERIVED
Source notices and limitations
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        e whole pelvis, seminal vesicles, and external/internal iliac nodes unless the lymph nodes were histologically negative). This trial, <a href="/clinicaltrials/NCT00002633">NCIC CTG PR.3/MRC UKPRO7</a> [NCT00002633], from the National Cancer Institute of Canada randomly assigned 1,205 patients with high-risk (PSA &gt;40 ng/mL or
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        nal/internal iliac nodes unless the lymph nodes were histologically negative). This trial, <a href="/clinicaltrials/NCT00002633">NCIC CTG PR.3/MRC UKPRO7</a> [NCT00002633], from the National Cancer Institute of Canada randomly assigned 1,205 patients with high-risk (PSA &gt;40 ng/mL or PSA &gt;20 ng/mL and Gleason score &#8805;
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        e whole pelvis, seminal vesicles, and external/internal iliac nodes unless the lymph nodes were histologically negative). This trial (<a href="/clinicaltrials/NCT00002633">NCIC CTG PR.3/MRC UKPRO7</a> [NCT00002633]) from the National Cancer Institute of Canada, randomly assigned 1,205 patients with high-risk (PSA &gt;40 ng/mL o
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        nal/internal iliac nodes unless the lymph nodes were histologically negative). This trial (<a href="/clinicaltrials/NCT00002633">NCIC CTG PR.3/MRC UKPRO7</a> [NCT00002633]) from the National Cancer Institute of Canada, randomly assigned 1,205 patients with high-risk (PSA &gt;40 ng/mL or PSA &gt;20 ng/mL and Gleason score &#8805
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      source update dates
      1. context
        Updated: May 14, 2025
        datetime
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        display
        May 14, 2025

    Preserved source evidence · Not medical advice