Clinical trial · Observational
Quality of Life for Subjects Receiving Androgen Deprivation Therapy and Have a Doubling in PSA of Either Less Than or Greater Than 1 Year
An Open-Label, Phase ll Trial Comparing FACT-P Scores For Subjects Who Are Indicated To Receive Androgen Deprivation Therapy And Have A Doubling In PSA Post Curative Therapy Of Either Less Than Or Greater Than One Year
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate if there is a difference in quality of life (as measured by FACT-P) in patients treated with androgen deprivation therapy (ADT) for biochemical failure (PSA recurrence) following surgery or radiation for prostate cancer depending on when ADT is initiated.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- A
- description
- Patients who have been identified as having a doubling in PSA from nadir of greater than one year
- label
- B
- description
- Patients who have been identified as having a doubling in PSA from nadir of less than one year.
Primary outcomes (1)
- measure
- Significant difference in FACT-P scores after 12 months between the 2 groups
- timeFrame
- 12 months
Secondary outcomes (3)
- measure
- PSA response
- timeFrame
- 12 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years or older * Received therapy of curative intent (surgery or radiotherapy) * Have a rising PSA which has doubled from a nadir value. * Histologically proven prostate cancer requiring androgen deprivation therapy for at least 12 months * Written informed consent to participate in the trial. Exclusion Criteria: * Known hypersensitivity to Zoladex, Casodex, ar any component of these products * Prior treatment with LHRH agonist or anti-androgens in the past 12 months * Any concomitant condition that would make it undesirable, in the physician's opinion, for the subject to participate in the trial or would jeopardize compliance with the protocol.
References
Publications (0)
Data not yet available