Hormone Therapy in Treating Patients With Locally Advanced or Metastatic Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00303784
First received: March 15, 2006
Last updated: August 23, 2013
Last verified: June 2008

March 15, 2006
August 23, 2013
March 2006
Not Provided
Cardiovascular morbidity and mortality [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00303784 on ClinicalTrials.gov Archive Site
  • Hormone activity by castrate levels of hormones [ Designated as safety issue: No ]
  • Failure free survival [ Designated as safety issue: No ]
  • Other toxicity [ Designated as safety issue: Yes ]
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Hormone Therapy in Treating Patients With Locally Advanced or Metastatic Prostate Cancer
Prostate Adenocarcinoma: TransCutaneous Hormones [PATCH] A Randomized-Controlled Trial of Transcutaneous Oestrogen Patches Versus LHRH Analogues in Prostate Cancer

RATIONALE: Testosterone can cause the growth of prostate cancer cells. Hormone therapy using estrogen and luteinizing hormone-releasing hormone analog may fight prostate cancer by lowering the amount of testosterone the body makes. Giving estrogen in a skin patch may improve quality of life and help patients live more comfortably.

PURPOSE: This randomized phase II trial is studying how well the estrogen skin patch works compared with luteinizing hormone-releasing hormone analog in treating patients with locally advanced or metastatic prostate cancer.

OBJECTIVES:

Primary

  • Compare the cardiovascular system-related morbidity and mortality in patients with locally advanced or metastatic prostate cancer treated with transcutaneous estrogen patches vs luteinizing hormone-releasing hormone analogues.

Secondary

  • Compare the activity of these treatments, in terms of castrate level of hormones, failure-free survival, and biochemical failure, in these patients.
  • Compare other toxicities, including osteoporosis, hot flushes, gynecomastia, and anemia, in patients treated with these regimens.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms at 1(control):2 (patch) ratio.

  • Arm I (control): Patients receive luteinizing hormone-releasing hormone analogues as per local practice in the absence of unacceptable toxicity.
  • Arm II (patch): Patients receive 3 transcutaneous estrogen patches, changing twice weekly for 4 weeks. Patients' testosterone levels are measured at week 4. Patients whose testosterone level is > 1.7 nmol/L continue to receive patch as before and have their testosterone level measured every 2 weeks. Patients whose testosterone level is < 1.7 nmol/L at week 4 or any other point receive 2 transcutaneous estrogen patches changed twice weekly in the absence of unacceptable toxicity.

Quality of life is assessed at baseline; at weeks 4, 8, and 12; every 3 months for 20 months; and then every 6 months thereafter.

After completion of study treatment, patients are followed periodically.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Treatment
  • Anemia
  • Cardiovascular Complications
  • Hot Flashes
  • Osteoporosis
  • Prostate Cancer
  • Drug: releasing hormone agonist therapy
  • Drug: transdermal estrogen
Not Provided
Langley RE, Cafferty FH, Alhasso AA, Rosen SD, Sundaram SK, Freeman SC, Pollock P, Jinks RC, Godsland IF, Kockelbergh R, Clarke NW, Kynaston HG, Parmar MK, Abel PD. Cardiovascular outcomes in patients with locally advanced and metastatic prostate cancer treated with luteinising-hormone-releasing-hormone agonists or transdermal oestrogen: the randomised, phase 2 MRC PATCH trial (PR09). Lancet Oncol. 2013 Apr;14(4):306-16. doi: 10.1016/S1470-2045(13)70025-1. Epub 2013 Mar 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
Not Provided

DISEASE CHARACTERISTICS:

  • Must meet 1 of the following criteria:

    • Newly diagnosed patients with any of the following:

      • Stage T3 or T4, NX, M0 histologically confirmed prostate adenocarcinoma with prostate-specific antigen (PSA) ≥ 20 ng/mL or Gleason score ≥ 6
      • Any T, N+, M0, or any T, any N, M+ histologically confirmed prostate adenocarcinoma
      • Multiple sclerotic bone metastases with a PSA ≥ 50 ng/mL without histological confirmation
    • Patients with histologically confirmed prostate adenocarcinoma previously treated with radical surgery or radiotherapy who are currently in relapse with on of the following:

      • PSA ≥ 4 ng/mL and rising with doubling time less than 6 months
      • PSA ≥ 20 ng/mL
  • Must have written informed consent
  • Intention to treat with long-term androgen-deprivation therapy
  • Normal testosterone level prior to hormonal treatment

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • No other prior or current malignant disease or cardiovascular system disease that is likely to interfere with study treatment or assessment
  • No cardiovascular disease, including any of the following:

    • History of cerebral ischemia (e.g., stroke or transient ischemic attack) within the past 2 years
    • History of deep vein thrombosis or pulmonary embolism confirmed radiologically
    • History of myocardial infarction (MI) within the past 6 months OR MI more than 6 months ago with evidence of q-wave anterior infarct on ECG

      • ECHO or MUGA required for patients with history of ischemic heart disease
    • Left Ventricular Ejection Fraction ≤ 40%
  • No condition or situation that could preclude protocol treatment or compliance with follow-up schedule

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 12 months since prior adjuvant or neoadjuvant hormonal therapy for localized prostate cancer AND therapy lasted ≤ 12 months in duration
  • No prior systemic therapy for locally advanced or metastatic prostate cancer
  • No concurrent participation in another clinical trial of prostate cancer treatment that would preclude study therapy or outcome measures
  • Concurrent prophylactic radiotherapy to prevent gynecomastia allowed
Male
Not Provided
No
United Kingdom
 
NCT00303784
CDR0000455583, MRC-PATCH, EU-205106, MRC-PR09, ISRCTN70406718, EUDRACT-2005-001030-33
Not Provided
Not Provided
Imperial College London
Not Provided
Study Chair: Paul D. Abel Charing Cross Hospital
National Cancer Institute (NCI)
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP