Trial · Interventional

CompletedNot applicableResults postedRegistry data

Androgen Deprivation Therapy Prior to Prostatectomy for Patients With Intermediate and High Risk Prostate Cancer

NCTNCT01542021Other id11-182

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Overview

Status: Completed
Phase: Not applicable
Enrollment: 41 participants (actual)
Sponsor: Memorial Sloan Kettering Cancer Center · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 24 Feb 2012
Primary completion: 30 Sept 2024
Completion: 30 Sept 2024
First posted: 1 Mar 2012 (estimated)
Last update posted: 29 Jul 2026
Conditions: Prostate Cancer · Prostatic Adenocarcinoma

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201520202025

N/A
Androgen Deprivation Therapy Prior to Prostatectomy for Patients With Intermediate and High Risk Prostate Cancer
NCT01542021
24 Feb 2012 to 30 Sept 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Degarelix is an approved drug that is used to treat prostate cancer by lowering testosterone levels in the body. Degarelix is commonly given with radiation for prostate cancer, but less frequently with surgery since there has been no proven benefit with this approach. The investigators do not expect the patient to benefit directly from treatment with degarelix since their prostate will be removed shortly after the drug is given. Instead, the investigators hope to learn about how degarelix and other treatment that lowers your testosterone effects prostate cancer cells and use this information to develop better treatments in the future.

Interventions

degarelix injectionDrug
degarelix injectionDrug
androgen deprivation therapyDrug

Arms4

Experimental
Untreated patients degarelix injection occur at days 4± 1
Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy
Experimental
Untreated patients degarelix injection occur at days and 7± 1.
Treatment will consist of a single 240 mg injection of degarelix 7±1 day before radical prostatectomy
Experimental
treated patients with androgen deprivation
Patients already treated with androgen deprivation are assigned to Cohort 3 and maintained on current androgen deprivation therapy until they undergo or have already undergone RP at MSKCC. Will include patients who have already undergone hormonal therapy (of any duration between 1 and 6 months) prior to prostatectomy.
Experimental
Untreated patients degarelix injection occur at days 14±1
Treatment will consist of a single 240 mg injection of degarelix 14±1 day before radical prostatectomy

Primary outcomes1

Outcomes the sponsor listed as primary.

Percent Change in Prostate Cancer Cell Proliferation (Ki-67 Levels)
Time frame · Baseline and up to 2 years
Registry description
The primary endpoint is the change in the rate of proliferation (Ki-67), as evaluated by IHC in anatomically matched tumor foci from the pre-treatment diagnostic biopsy and the RP specimen. The levels in pre-treatment biopsy serve as the baseline. Ki-67 is a widely accepted nuclear marker for cell proliferation.

Secondary outcomes(2)

Median Percentage of Cells From Biopsy and Surgery That Are Positive For Ki-67
Time frame · up to 2 years
Registry description
The secondary endpoint is PTEN status by IHC in the diagnostic biopsy and RP specimens. PTEN status will be determined by an IHC method that has been validated using control prostate cell lines and tissues at MSKCC. The PTEN status will be reported in binary fashion as "retained" (diffuse moderate immunoreactivity retained in benign glands as well as adenocarcinoma on 100X magnification) or "null" (complete loss of nuclear and cytoplasmic immunoreactivity in tumor cells while expression is retained in surrounding stroma.
Record Participant Biomarker Results and Correlates of Response
Time frame · Up to 14+/- days
Registry description
through expression profiling of prostate cancer after three time intervals of androgen deprivation therapy and correlate with PTEN and ERG status, proliferation rate, apoptotic rate, and histologic response

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and up to 2 years

Percent Change in Prostate Cancer Cell Proliferation (Ki-67 Levels)

Group	Value (percent change)
Untreated Patients Degarelix Injection Occur at Days 4± 1	32
Untreated Patients Degarelix Injection Occur at Days and 7± 1.	27
Untreated Patients With Androgen Deprivation	88
Untreated Patients Degarelix Injection Occur at Days 14±1	NA

Secondary and other outcome results(3)

Secondary outcomeMedian· up to 2 years

Median Percentage of Cells From Biopsy and Surgery That Are Positive For Ki-67

Group	Value (% positive cells)
Untreated Patients Degarelix Injection Occur at Days 4± 1	15
Untreated Patients Degarelix Injection Occur at Days and 7± 1.	8
Untreated Patients With Androgen Deprivation	NA
Untreated Patients Degarelix Injection Occur at Days 14±1	NA

Secondary outcomeMean· Up to 14+/- days

Record Participant Biomarker Results and Correlates of Response

Group	Value (% change)
Untreated Patients Degarelix Injection Occur at Days 4± 1	-3.6
Untreated Patients Degarelix Injection Occur at Days and 7± 1.	-13.9
Untreated Patients With Androgen Deprivation	NA
Untreated Patients Degarelix Injection Occur at Days 14±1	NA

Post hoc outcome· 2 years

To Explore the Association Between PI3K Pathway (pAKT and pS6) and Prostate Cancer Proliferation and Apoptosis Rates After Treatment With Androgen Deprivation Therapy in Relation to Other Markers of Prostate Cancer (ERG, AR and NCOA2).

Group	Value
Untreated Patients Degarelix Injection Occur at Days 4± 1	not posted
Untreated Patients Degarelix Injection Occur at Days and 7± 1.	not posted
Untreated Patients With Androgen Deprivation	not posted
Untreated Patients Degarelix Injection Occur at Days 14±1	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Untreated Patients Degarelix Injection Occur at Days 4± 1Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy, depending on treatment arm.	2 / 17	7 / 17	13 / 17
Untreated Patients Degarelix Injection Occur at Days and 7± 1.Treatment will consist of a single 240 mg injection of degarelix 7±1 day before radical prostatectomy degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 7 ± 1 day before radical prostatectomy, depending on treatment arm.	0 / 17	5 / 17	17 / 17
Untreated Patients With Androgen DeprivationPatients already treated with androgen deprivation are assigned to Cohort 3 and maintained on current androgen deprivation therapy until they undergo or have already undergone RP at MSKCC. Will include patients who have already undergone hormonal therapy (of any duration between 1 and 6 months) prior to prostatectomy. androgen deprivation therapy	1 / 3	0 / 3	1 / 3
Untreated Patients Degarelix Injection Occur at Days 14±1Treatment will consist of a single 240 mg injection of degarelix 14±1 day before radical prostatectomy degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 7 ± 1 day before radical prostatectomy, depending on treatment arm.	0 / 1	0 / 1	0 / 1

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedZengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2. PMID 34350976

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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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