Overview

Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy in Prostate Cancer

Status:
Unknown status

Trial end date:
2016-06-01

Target enrollment:
0

Participant gender:
Male

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

National Taiwan University Hospital

Treatments:

Androgens
Ascorbic Acid
Estrogens, Conjugated (USP)
Hormones
Methyltestosterone

Criteria

Inclusion Criteria:

1. Age>20 years

2. Histopathology proven prostate adenocarcinoma

3. Non-metastatic localized disease

4. Prostate cancer is deemed high-risk for recurrence(PSA>20 ng/ml, Gleason score>=8, or
clinical staging>=T2c)

5. Subjects have undergone prostate cryoablation as the definitive treatment prior to
enrolling the study

6. 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.

7. 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.

8. Subjects are willing to sign the informed consent and agree to comply with the study
procedures

Exclusion Criteria:

1. Those who have been treated with > 8 weeks (collectively if not continuously) of
neoadjuvant ADT prior to screening.

2. 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

3. Other conditions the investigators think may affect subject compliance or safety