Prostate Cancer
Conditions
Brief summary
Assessment of the International Index of Erectile Function-5 (IIEF-5) score at six months after hormonal therapy cessation, indicating recovery in at least 70% of the study population.
Detailed description
Time from hormonal therapy cessation to sexual function recovery relative to pre-treatment levels (SFRT), Correlation of erectile function recovery with dose to the penile bulb, crura, internal pudendal artery, periprostatic neurovascular bundles, and testes, bPFS per Phoenix criteria (nadir + 2 ng/mL), Local control, defined as time from treatment to local recurrence or last follow-up, dPFS, defined as time from treatment to distant metastases or last follow-up, Acute and late urinary and rectal toxicity, measured using RTOG and IPSS scales, QoL scores from questionnaires (EORTC QLQ-C30, PR25, IIEF-5), Financial toxicity assessment (PROFFIT questionnaire), OS, defined as time from treatment to death or last follow-up
Interventions
Sponsors
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the International Index of Erectile Function-5 (IIEF-5) score at six months after hormonal therapy cessation, indicating recovery in at least 70% of the study population. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time from hormonal therapy cessation to sexual function recovery relative to pre-treatment levels (SFRT), Correlation of erectile function recovery with dose to the penile bulb, crura, internal pudendal artery, periprostatic neurovascular bundles, and testes, bPFS per Phoenix criteria (nadir + 2 ng/mL), Local control, defined as time from treatment to local recurrence or last follow-up, dPFS, defined as time from treatment to distant metastases or last follow-up, Acute and late urinary and rectal toxicity, measured using RTOG and IPSS scales, QoL scores from questionnaires (EORTC QLQ-C30, PR25, IIEF-5), Financial toxicity assessment (PROFFIT questionnaire), OS, defined as time from treatment to death or last follow-up | — |
Countries
Italy
Outcome results
None listed