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Prostate Adenocarcinoma: TransCutaneous Hormones [PATCH] A Randomized-Controlled Trial of Transcutaneous Oestrogen Patches Versus LHRH Analogues in Prostate Cancer

Phase 2
Open (Enrolling)
Anemia, Cardiovascular Complications, Hot Flashes, Osteoporosis, Prostate Cancer

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Trial Information

Prostate Adenocarcinoma: TransCutaneous Hormones [PATCH] A Randomized-Controlled Trial of Transcutaneous Oestrogen Patches Versus LHRH Analogues in Prostate Cancer



- 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.


- 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.

Inclusion Criteria


- 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

- 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


- 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


- 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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Cardiovascular morbidity and mortality

Safety Issue:


Principal Investigator

Paul D. Abel

Investigator Role:

Study Chair

Investigator Affiliation:

Charing Cross Hospital



Study ID:




Start Date:

March 2006

Completion Date:

Related Keywords:

  • Anemia
  • Cardiovascular Complications
  • Hot Flashes
  • Osteoporosis
  • Prostate Cancer
  • hot flashes
  • anemia
  • osteoporosis
  • cardiovascular complications
  • recurrent prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • adenocarcinoma of the prostate
  • Adenocarcinoma
  • Anemia
  • Osteoporosis
  • Prostatic Neoplasms
  • Hot Flashes