Can a short course of hormone therapy before prostate surgery reveal new clues about cancer?
NCT ID NCT01542021
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This trial investigates how a single injection of degarelix, a drug that lowers testosterone, affects prostate cancer cells when given just days before prostate removal surgery. Researchers aim to measure changes in cell growth (Ki-67 levels) by comparing biopsy and surgical tissue samples. The study enrolls men with intermediate- or high-risk prostate cancer who are scheduled for prostatectomy. While participants are not expected to benefit directly, the findings may guide the development of future targeted therapies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- degarelix injection
- What this could lead to
- If successful, this could help researchers develop better targeted treatments for prostate cancer by understanding how hormone therapy affects cancer cells.
- What could go wrong
- This is a small, early-stage study not designed to show direct patient benefit. The drug is given only days before surgery, so any effects on cancer cells may be limited.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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41 people
The number who actually took part.
- Started
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Feb 2012
- Finished
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Sep 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologic confirmation of prostatic adenocarcinoma by MSKCC inclusive of the following: * 3 or more positive biopsy cores or equivalent tumor specimen as confirmed by pathologist * At least 2 cores containing ≥3 mm of tissue with carcinoma or equivalent tumor specimen as confirmed by pathologist * A primary tumor Gleason score ≥ 7 * Adequate primary biopsy tissue or equivalent tumor specimen as confirmed by pathologist available for protocol required analysis (i.e. bladder or TURP specimen) * Planning to have or have had a radical prostatectomy (RP) at MSKCC * Candidates may have a history of deep vein thrombosis, pulmonary embolism, and/or cerebrovascular accident, or require concomitant systemic anticoagulation, if otherwise deemed to be suitable for RP * Karnofsky performance status \>70% (Appendix A) * Sexually active fertile subjects, and their partners, must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 3 months after the dose of study drug(s) for Cohorts 1 , 2 and 4, and for 3 months after the surgery for Cohort 3 * For cohorts 1,2 and 4 only:, non-castrate testosterone level (\>100 ng/dL) * For cohort 3 only:, 1-6 months of androgen deprivation therapy (gonadotropin hormone releasing analogs with or without an anti-androgen) prior to prostatectomy with a castrate testosterone level of \<50 ng/dL within 1 month prior to prostatectomy. Exclusion Criteria: * Histologic variants in the primary tumor (histologic variants other than adenocarcinoma) * Current or prior chemotherapy * The use of the 5-alpha-reductase inhibitor dutasteride must be discontinued within 4 weeks of degarelix injection for Cohort 1, 2 and 4, and within 4 weeks of surgery for Cohort 3. * Saw palmetto administered with the intent to treat the patient's malignancy within 1 week of degarelix injection for Cohorts 1, 2 and 4, and for within 1 week of surgery for Cohort 3 * Current or prior radiation therapy to the prostate * Active infection or intercurrent illness * Concomitant therapy with any other experimental drug * For cohorts 1, 2 and 4 only:, current or prior hormonal therapy (e.g., gonadotropin hormone releasing analogs, megestrol acetate, or antiandrogens) are exclusionary
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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