ProstatePhase 2NCT00586898
Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle
A Phase 2 study testing GnRH, Ketoconazole and Bicalutamide in people with Prostate and Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Objective: To determine the response to rapid hormonal cycling in patients with non-castrate prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate, Cancer, Hormonal Cycling
- What is being tested?
- GnRH, Ketoconazole and Bicalutamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to Mar 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Patients residing in the following clinical states wit! be considered: A. Rising PSA: Patients with a history of localized disease who have undergone definitive radiation or surgery. These patients must demonstrate progression of disease biochemically as outlined below. Patients in this group may not have radiographically evident disease.
- Non-castrate metastatic: Patients must present with radiographic evidence of metastatic disease at the time of diagnosis or after treatment for localized disease. These patients must show newly detected disease or progressing disease in bone or in soft tissue. Biochemical progression is defined as: minimum no. of determinations: 3 Interval: >2 weeks Minimal Baseline PSA value (ng/ml): 2 Minimal % increase in range of values: 50%
- Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC.
- Patient must have level of serum testosterone above the lower limit of normal.
- Karnofskcy performance status (KPS) >_70%.
- Patients must have adequate organ function as defined by the following laboratory criteria:
Show all 14Show fewer
- WBC >_3500/mm3, platelet count >_100,000/mm3.
- Bilirubin <2.0 mg/dl or SGOT <3.0 X the upper limit of normal.
- Creatinine <_1.6 mg/dl or creatinine clearance >_60 cc/min.
- Prior hormonal therapy is allowed as:
- Neoadjuvant treatment prior to radiation therapy or radical prostatectomy, provided that the total duration of exposure does not exceed 10 months.
- One cycle of intermittent therapy up to a maximum exposure of 10 months.
- Patients must be at least 18 years of age.
- Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment
Who cannot join
- Clinically significant cardiac disease (New York Heart Association Class III/IV),or severe debilitating puhnonary disease.
- Uncontrolled serious active infection.
- Anticipated survival of less than 3 months.
- Active CNS or epiduraltumor
- Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Objective: To determine the response to rapid hormonal cycling in patients with non-castrate prostate cancer.
- Conditions
- Prostate, Cancer, Hormonal Cycling
- Being tested
- GnRH, Ketoconazole, Bicalutamide, Testosterone transdermal gel, Estrogen transdermal patch
- Keywords
- Prostate, Cancer, Hormones, 01-085, ANTIFUNGAL ANTIBIOTICS, ESTROGENS, LUPRON, TESTOSTERONE, ZOLADEX
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRHDrug
Also called LUPRON, ZOLADEX
leuprolide and goserelin are gonadotropin-releasing hormone analogues
KetoconazoleDrug
Also called Nizoral
An imidazole antifungal agent. reduces adrenal and testicular androgen production in men
BicalutamideDrug
Also called Casodex
A pure nonsteroidal antiandrogen
Testosterone transdermal gelDrug
Also called Androgel
an androgenic anabolic steroid
Estrogen transdermal patchDrug
Also called CLIMARA
Estradiol is the primary and most potent estrogen
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: GnRH; Drug: Ketoconazole; Drug: Bicalutamide; Drug: Testosterone transdermal gel; Drug: Estrogen transdermal patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
Complete Response: Normalization of the PSA (< or = to 4.0 for patients with castrate metastatic disease, or < 0.5 for patients with a rising PSA) that is maintained on 3 successive evaluations a minimum of 2 weeks apart. Partial Response: Decrease in PSA value by > or = to 50% from baseline value (without normalization) for 3 successive evaluations a minimum of 2 weeks apart. Stabilization: Patients who do not meet the criteria for PR or PROG for at least 90 days will be considered stable.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startJul 2001
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ProstateStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Howard Scher, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586898
- Sponsor's protocol ID
- 01-085
- Status last verified
- Feb 2016
- First submitted
- 21 Dec 2007
- Last updated
- 25 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle
- ClinicalTrials.gov ID
- NCT00586898
- Acronym / sponsor ID
- 01-085
- Conditions
- Prostate, Cancer, Hormonal Cycling
- Keywords
- Prostate, Cancer, Hormones, 01-085, ANTIFUNGAL ANTIBIOTICS, ESTROGENS, LUPRON, TESTOSTERONE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jul 2001
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 7 Jan 2008 (estimated)
- Results
- Posted 25 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To determine the response to rapid hormonal cycling in patients with non-castrate prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: GnRH, Drug: Ketoconazole, Drug: Bicalutamide, Drug: Testosterone transdermal gel, Drug: Estrogen transdermal patch |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- -Patients residing in the following clinical states wit! be considered: A. Rising PSA: Patients with a history of localized disease who have undergone definitive radiation or surgery. These patients must demonstrate progression of disease biochemically as outlined below. Patients in this group may not have radiographically evident disease.
- Non-castrate metastatic: Patients must present with radiographic evidence of metastatic disease at the time of diagnosis or after treatment for localized disease. These patients must show newly detected disease or progressing disease in bone or in soft tissue. Biochemical progression is defined as: minimum no. of determinations: 3 Interval: >2 weeks Minimal Baseline PSA value (ng/ml): 2 Minimal % increase in range of values: 50%
- Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC.
- Patient must have level of serum testosterone above the lower limit of normal.
- Karnofskcy performance status (KPS) >_70%.
Key exclusion criteria (5 listed)
- Clinically significant cardiac disease (New York Heart Association Class III/IV),or severe debilitating puhnonary disease.
- Uncontrolled serious active infection.
- Anticipated survival of less than 3 months.
- Active CNS or epiduraltumor
- Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GnRHAlso: LUPRON, ZOLADEXleuprolide and goserelin are gonadotropin-releasing hormone analogues | Drug | 1 |
| KetoconazoleAlso: NizoralAn imidazole antifungal agent. reduces adrenal and testicular androgen production in men | Drug | 1 |
| BicalutamideAlso: CasodexA pure nonsteroidal antiandrogen | Drug | 1 |
| Testosterone transdermal gelAlso: Androgelan androgenic anabolic steroid | Drug | 1 |
| Estrogen transdermal patchAlso: CLIMARAEstradiol is the primary and most potent estrogen | Drug | 1 |
Primary outcome
Response
Time frame: 6 months
Complete Response: Normalization of the PSA (< or = to 4.0 for patients with castrate metastatic disease, or < 0.5 for patients with a rising PSA) that is maintained on 3 successive evaluations a minimum of 2 weeks apart. Partial Response: Decrease in PSA value by > or = to 50% from baseline value (without normalization) for 3 successive evaluations a minimum of 2 weeks apart. Stabilization: Patients who do not meet the criteria for PR or PROG for at least 90 days will be considered stable.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Scher, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GnRH, Ketoconazole and Bicalutamide in people with Prostate and Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2016.