Prostate CancerPhase 3NCT01398657
Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy in Prostate Cancer
A Phase 3 study testing Adjuvant Androgen-Deprivation Therapy in people with Prostate Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This is an open-label randomized clinical study comparing primary prostate cryoablation alone (No-ADT group) with cryoablation plus short-term adjuvant androgen-deprivation therapy (Adj-ADT group) in the treatment of patients with high-risk localized prostate cancer. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Adjuvant Androgen-Deprivation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2011to Jun 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>20 years
- Histopathology proven prostate adenocarcinoma
- Non-metastatic localized disease
- Prostate cancer is deemed high-risk for recurrence(PSA>20 ng/ml, Gleason score>=8, or clinical staging>=T2c)
- Subjects have undergone prostate cryoablation as the definitive treatment prior to enrolling the study
- Subjects who have not been treated with any definitive treatments for prostate cancer, including radical prostatectomy or definitive radiotherapy. However, those who have undergone focal prostate cryoablation and have cancer recurrence are still eligible.
- Subjects may or may not have received neoadjuvant androgen-deprivation therapy (ADT) in the forms of either castration (medical) and/or antiandrogens. Surgical castration (orchiectomy) is not allowed.
- Subjects are willing to sign the informed consent and agree to comply with the study procedures
Who cannot join
- Those who have been treated with > 8 weeks (collectively if not continuously) of neoadjuvant ADT prior to screening.
- Subjects who have other cancer that is deemed not cured or are known less than 5 years except for basal cell carcinoma of the skin
- Other conditions the investigators think may affect subject compliance or safety
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Yeong-Shiau Pu, MD, PhD, 886-2-23123456 ext. 65249, yspu@ntu.edu.tw
Yeong-Shiau Pu, MD, PhD
About this study
Official title: Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy for High-Risk Localized Prostate Cancer - Open-Label Randomized Clinical Study
This is an open-label randomized clinical study comparing primary prostate cryoablation alone (No-ADT group) with cryoablation plus short-term adjuvant androgen-deprivation therapy (Adj-ADT group) in the treatment of patients with high-risk localized prostate cancer.
Read the detailed description
Subjects (N=182) who have high-risk prostate cancer and have undergone primary prostate cryotherapy will be screened and randomized in a 1:1 ratio to receive either adjuvant ADT (Adj-ADT) or No-ADT until disease progression. Screening and randomization will be done within four weeks after cryoablation. Only those who are assigned to Adj-ADT will receive ADT for a total of 12 months. PSA will be checked every 3 months in the first year after Cryo and every 6 months thereafter. Long-term follow-up parameters include serum PSA and protocol-mandated biopsies (at 36 months after Cryo, irrespective of PSA levels if recurrence has not been documented). For-cause biopsy will also be done if post-Cryo PSA elevation reaches the Phoenix criteria (Nadir + 2 ng/ml) or when the treating physician thinks it necessary to document tumor recurrence.
- Conditions
- Prostate Cancer
- Being tested
- Adjuvant Androgen-Deprivation Therapy
- Keywords
- localized, High risk, Prostate Cancer, Randomized, Cryotherapy, Cryoablation, Adjuvant, Androgen Deprivation Therapy, Hormone therapy, ADT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant Androgen-Deprivation TherapyDrug
Also called Adjuvant hormone therapy
Short-term adjuvant androgen-deprivation therapy
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant Androgen-Deprivation Therapy | Experimental | Cryotherapy with Short-term Adjuvant Androgen-Deprivation Therapy Receives: Drug: Adjuvant Androgen-Deprivation Therapy |
| No adjuvant therapy | No intervention | Cryotherapy without any adjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite trifecta endpoint of treatment failure at 3 years after cryoablation
A composite trifecta endpoint of treatment failure at 3 years after cryoablation defined by either of the three, biochemical (PSA) recurrence (by the Phoenix criteria) or biopsy-proven recurrence or initiation of hormone therapy for disease recurrence whichever comes first.
Measured: 3 years
Secondary outcomes (6)
Time to the composite endpoint of treatment failure since cryoablation
Time to the composite endpoint of treatment failure since cryoablation
Measured: 3 years
Biochemical (PSA) recurrence rate at 3 years
Biochemical (PSA) recurrence rate at 3 years
Measured: 3 years
Biochemical (PSA) recurrence-free survival
Biochemical (PSA) recurrence-free survival
Measured: 3 years
Biopsy-proven recurrence rate at 3 years
Biopsy-proven recurrence rate at 3 years
Measured: 3 years
Biopsy-proven recurrence-free survival
Biopsy-proven recurrence-free survival
Measured: 3 years
Safety profile
Hormone therapy related toxicities such as liver function alteration, libido changes, alterations in quality of life as measured by QLQ C30 and PR25 questionnaire.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2014 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yeong-Shiau Pu, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398657
- Sponsor's protocol ID
- 201103057MB
- Status last verified
- Mar 2012
- First submitted
- 14 Jul 2011
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy for High-Risk Localized Prostate Cancer - Open-Label Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT01398657
- Acronym / sponsor ID
- 201103057MB
- Conditions
- Prostate Cancer
- Keywords
- localized, High risk, Prostate Cancer, Randomized, Cryotherapy, Cryoablation, Adjuvant, Androgen Deprivation Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label randomized clinical study comparing primary prostate cryoablation alone (No-ADT group) with cryoablation plus short-term adjuvant androgen-deprivation therapy (Adj-ADT group) in the treatment of patients with high-risk localized prostate cancer.
Detailed description
Subjects (N=182) who have high-risk prostate cancer and have undergone primary prostate cryotherapy will be screened and randomized in a 1:1 ratio to receive either adjuvant ADT (Adj-ADT) or No-ADT until disease progression. Screening and randomization will be done within four weeks after cryoablation. Only those who are assigned to Adj-ADT will receive ADT for a total of 12 months. PSA will be checked every 3 months in the first year after Cryo and every 6 months thereafter. Long-term follow-up parameters include serum PSA and protocol-mandated biopsies (at 36 months after Cryo, irrespective of PSA levels if recurrence has not been documented). For-cause biopsy will also be done if post-Cryo PSA elevation reaches the Phoenix criteria (Nadir + 2 ng/ml) or when the treating physician thinks it necessary to document tumor recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant Androgen-Deprivation Therapy | Experimental | Drug: Adjuvant Androgen-Deprivation TherapyCryotherapy with Short-term Adjuvant Androgen-Deprivation Therapy |
| No adjuvant therapy | No intervention | –Cryotherapy without any adjuvant therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age>20 years
- Histopathology proven prostate adenocarcinoma
- Non-metastatic localized disease
- Prostate cancer is deemed high-risk for recurrence(PSA>20 ng/ml, Gleason score>=8, or clinical staging>=T2c)
- Subjects have undergone prostate cryoablation as the definitive treatment prior to enrolling the study
Key exclusion criteria (3 listed)
- Those who have been treated with > 8 weeks (collectively if not continuously) of neoadjuvant ADT prior to screening.
- Subjects who have other cancer that is deemed not cured or are known less than 5 years except for basal cell carcinoma of the skin
- Other conditions the investigators think may affect subject compliance or safety
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 |
|---|---|---|
| Adjuvant Androgen-Deprivation TherapyAlso: Adjuvant hormone therapyShort-term adjuvant androgen-deprivation therapy | Drug | Adjuvant Androgen-Deprivation Therapy |
Primary outcome
A composite trifecta endpoint of treatment failure at 3 years after cryoablation
Time frame: 3 years
A composite trifecta endpoint of treatment failure at 3 years after cryoablation defined by either of the three, biochemical (PSA) recurrence (by the Phoenix criteria) or biopsy-proven recurrence or initiation of hormone therapy for disease recurrence whichever comes first.
6 secondary outcomes
Time to the composite endpoint of treatment failure since cryoablation
Time frame: 3 years
Biochemical (PSA) recurrence rate at 3 years
Time frame: 3 years
Biochemical (PSA) recurrence-free survival
Time frame: 3 years
Biopsy-proven recurrence rate at 3 years
Time frame: 3 years
Biopsy-proven recurrence-free survival
Time frame: 3 years
Safety profile
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
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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.
Yeong-Shiau Pu, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adjuvant Androgen-Deprivation Therapy in people with Prostate Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Nov 2012. 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 Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yeong-Shiau Pu, MD, PhD (886-2-23123456 ext. 65249, yspu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite trifecta endpoint of treatment failure at 3 years after cryoablation (time frame: 3 years). 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 14 Nov 2012.