Trial · Interventional
TerminatedPhase 4Registry dataA Study of Neoadjuvant Hormone Therapy in Patient With Advanced Prostate Cancer Undergoing Radical Prostatectomy.
This trial was stopped early.
Reason given at the registry: Due to the limited potential patients pool, the enrollment goal could not be achieved. After review and communication, the decision to teminate study was made.
Overview
- Status
- Terminated
- Phase
- Phase 4
- Enrollment
- 9 participants (actual)
- Sponsor
- AstraZeneca · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
China
- Start
- 28 Jan 2021
- Primary completion
- 9 Nov 2022
- Completion
- 9 Nov 2022
- First posted
- 3 Jun 2019
- Last update posted
- 16 Dec 2022
- Conditions
- Advanced Prostate Cancer
Timeline
1 trial · 1 stopped early
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4Terminated
A Study of Neoadjuvant Hormone Therapy in Patient With Advanced Prostate Cancer Undergoing Radical Prostatectomy.
NCT0397111028 Jan 2021 to 9 Nov 2022
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is A Multi-centre, Single-arm, Prospective, Interventional Study to Assess Efficacy and Safety of Neoadjuvant Hormone Therapy using Zoladex (Goserelin) and Casodex (Bicalutamide) in Patients with Advanced Prostate Cancer Undergoing Radical Prostatectomy, to assess the efficacy by resectability rate of neoadjuvant hormone therapy (NHT) in subjects with advanced prostate cancer.
Interventions
- Zoladex and CasodexDrug
Arms1
Experimental
Zoladex and Casodex
Subjects who are diagnosed with advanced prostate cancer at clinical stage of T3 and T4 (N0 or N1, M0 or M1 with five or fewer extra-pelvic lesions) are the target population of this study. The eligible subjects will receive Casodex 50 mg orally per day in combination with Zoladex 10.8 mg implant subcutaneously as neoadjuvant therapy per 12 weeks for up to 24 weeks.
Primary outcomes1
Outcomes the sponsor listed as primary.
Resectability rate for primary tumour (the resectability will be assessed by central review using a digital rectal examination and confirmed by CT or MRI)
Time frame · at 24 week
Registry description
To assess the efficacy by resectability rate of neoadjuvant hormone therapy (NHT) in subjects with advanced prostate cancer
Secondary outcomes(11)
Radical prostatectomy rate
Time frame · From baseline to 24 week
Registry description
Which will be derived using the number of patient who will conduct the radical prostatectomy at 24 week.
The mean PSA by the end of NHT
Time frame · From baseline to 24 week
Registry description
which will be derived using the value of mean PSA by the end of NHT
Percentage of positive surgical margin for primary tumour
Time frame · From baseline to 24 week
Registry description
Which will be derived using the number of positive surgical margin at 24 week
Incidence of seminal vesicle invasion
Time frame · From baseline to 24 week.
Registry description
Which will be derived using the value of incidence of seminal vesicle invasion at 24 week
Percentage of pathological downstaging
Time frame · From baseline to 24 week
Registry description
Which will be derived using the number of pathological downstaging at 24 week.
surgical-related variables at 12 weeks, potent rates in erectile function at 12 weeks after surgery
Time frame · From 24 week to 36 week
Registry description
Which will be derived using the value of observe surgical-related variables and complications at week 36
PFS
Time frame · From baseline to the end of study
Registry description
Which will be derived using the number of PFS at the end of study
AEs/SAEs
Time frame · From baseline to 28 week
Registry description
To evaluate the safety of NHT using goserelin and bicalutamide
PSA change from baseline
Time frame · From baseline to 24 week
Registry description
Which will be derived using the value of PSA at the baseline.
Involvement of bilateral pelvic lymph nodes
Time frame · From baseline to 24 week
Registry description
Which will be derived using the value of involvement of bilateral pelvic lymph nodes at 24 week.
OS
Time frame · From baseline to the end of study
Registry description
Which will be derived using the number of OS at the end of study.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
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.
- Result1. Montironi R, Schulman CC. Pathological changes in prostate lesions after androgen manipulation. J Clin Pathol 1998; 51:5-12. 2. Witjes WP, Schulman CC, Debruyne FM. Preliminary results of a prospective randomized study comparing radical prostatectomy versus radical prostatectomy associated with neoadjuvant hormonal combination therapy in T2-3 N0 M0 prostatic carcinoma. Urology 1997;49(suppl):65-9. 3. Labrie F, Cusan L, Gomez JL, et al. Neoadjuvant hormonal therapy: the Canadian experience. Urology 1997;49(suppl):56-60. 4. Soloway MS, Sharifi F, Wajsman Z, et al. Random prospective study comparing radical prostatectomy alone versus radical prostatectomy preceded by androgen blockade in clinical stage B2 (T2bNxM0) prostate cancer. J Urol 1995; 154:424-8. 5. Hugosson J, Abrahamsson PA, Ahlgren G, et al. The risk of malignancy in the surgical margin at radical prostatectomy is reduced almost three-fold in patients given neoadjuvant hormone treatment. Eur Urol 1996; 29:413-16.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- Not stated
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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