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Trial · Observational

Not yet recruitingPhase not statedRegistry data

PRIAPUS-PCa Study: Stereotactic Body Radiation Therapy (SBRT) and Androgen Deprivation Therapy (ADT) Impact on Sexual Function on Men With Unfavorable Intermediate Risk Prostate Cancer

Short name PRIAPUS-PCa

NCTNCT07460726 (opens ClinicalTrials.gov in a new tab)Other id1219
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Goserelin, does not test it. It appears in the description.

Overview

Status
Not yet recruiting
Phase
Phase not stated
Enrollment
130 participants (estimated)
Sponsor
CancerCare Manitoba · Other
Design
Not stated
Countries
1 country

Canada

Start
16 Mar 2026 (estimated)
Primary completion
16 Mar 2028 (estimated)
Completion
31 Dec 2029 (estimated)
First posted
10 Mar 2026
Last update posted
10 Mar 2026
Conditions
Prostate Cancer (Adenocarcinoma) · Erectile Abnormalities · Sexual Dysfunction Male

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20262027202820292030
  1. Ph –

    PRIAPUS-PCa

    NCT07460726

    est. 16 Mar 2026 to est. 31 Dec 2029

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study looks at how combined radiation and hormone therapy affects sexual function in men with a specific type of prostate cancer, before and after treatment.

Interventions

  • SBRT combined with ADTCombination product

Arms1

  • Other

    Observational

    Prostate cancer patients receiving SBRT and ADT

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in erectile dysfunction severity from baseline to 24 months, as measured by the change in International Index of Erectile Function 5-item version (IIEF-5) score.

    Time frame · Baseline, 3, 9, 15, and 24 months post-SBRT

    Registry description

    Outcome Measure Title: Change in Erectile Function Score as Measured by the International Index of Erectile Function-5 (IIEF-5 / SHIM) Measurement Tool: International Index of Erectile Function-5 (IIEF-5, also known as SHIM) Unit of Measure: Total IIEF-5 score (range 1-25; higher scores indicate better erectile function) Derived Unit: Change in IIEF-5 score from baseline to 24 months (continuous variable, points)

Secondary outcomes(5)

  1. Proportion of patients with clinically significant (moderate to severe) erectile dysfunction

    Time frame · Baseline, 3, 9, 15, and 24 months

    Registry description

    Measurement Tool: IIEF-5 (SHIM) Unit of Measure: Percentage (%) of patients with IIEF-5 score ≤ 11

  2. Change in sexual function, as measured by the Expanded Prostate Cancer Index Composite 26-item version (EPIC-26) sexual domain score

    Time frame · Baseline, 3, 9, 15, and 24 months

    Registry description

    Measurement Tool: EPIC-26 Questionnaire - Sexual Domain Unit of Measure: Standardized domain score (0-100 scale; higher scores indicate better sexual function)

  3. Hormonal Domain Score of the Expanded Prostate Cancer Index Composite (EPIC-26)

    Time frame · Baseline, 3, 9, 15, and 24 months

    Registry description

    Measurement Tool: EPIC-26 Questionnaire - Hormonal Domain Unit of Measure: Standardized domain score (0-100 scale; higher scores indicate better hormonal function)

  4. Ejaculatory Function Score as Measured by the Male Sexual Health Questionnaire - Ejaculation Scale (MSHQ-ES-8)

    Time frame · Baseline, 3, 9, 15, and 24 months

    Registry description

    Measurement Tool: Male Sexual Health Questionnaire - Ejaculation Scale (ES-8) Unit of Measure: Total ES-8 score (range 3-40; higher scores indicate worse ejaculatory function)

  5. Health-Related Quality of Life Score as Measured by EORTC QLQ-ELD14

    Time frame · Baseline, 3, 9, 15, and 24 months (for patients >70 years)

    Registry description

    Measurement Tool: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Elderly Module (EORTC QLQ-ELD14) Unit of Measure: Standardized subscale scores (0-100 scale): Functional scales (higher = better functioning) Symptom scales (higher = greater symptom burden)

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

Studies3

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2020

4 results

Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer.

Shore et al. 2020The New England journal of medicinecited by 346

PMID 32469183DOI 10.1056/nejmoa2004325PUB-32469183

Full text at the publisher4 results
Publisher pageSee results (4)

More studies

2 studies on this page

PubMed tag: none · 2023

Testosterone as a Biomarker for Quality of Life (QOL) Following Androgen Deprivation Therapy (ADT) and Stereotactic Body Radiotherapy (SBRT).

Shah et al. 2023Cureuscited by 6

PMID 37791195PMC10544092DOI 10.7759/cureus.44440PUB-37791195

CC BY
Download PDF

PubMed tag: none · 2018

Recovery of Serum Testosterone Levels and Sexual Function in Patients Treated With Short-term Luteinizing Hormone-releasing Hormone Antagonist as a Neoadjuvant Therapy Before External Radiotherapy for Intermediate-risk Prostate Cancer: Preliminary Prospective Study.

Inoue et al. 2018Clinical genitourinary cancercited by 10

PMID 29051056DOI 10.1016/j.clgc.2017.09.009PUB-29051056

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Men aged 18-80 years with biopsy-proven UIR-PCa (National Comprehensive Cancer Network \[NCCN\] criteria: Gleason score 7 (4+3), PSA 10-20 ng/mL, or clinical stage T2b-T2c) * Planned treatment with SBRT (36.25-37.5 Gy in 5 fractions) and ADT (6 months) * Baseline sexual function assessment available (International Index of Erectile Function \[IIEF-5, also known as SHIM\] score ≥ 12 or pre-selection erection status score of 1-3: erection insufficient for intercourse, sufficient but not optimal, or normal) * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Written informed consent to participate. Exclusion Criteria: * Prior pelvic radiotherapy, prostate surgery, ADT, or chemotherapy * Pre-existing severe sexual dysfunction (IIEF-5 score \< 12 or pre-selection erection status score of 0: no erection) * Hypogonadism at presentation (baseline testosterone below normal range) * Contraindications to SBRT or ADT * Metastatic disease, second malignancy, or previous malignancies. * Benign or malignant penile diseases. * Use of medications altering ejaculation (e.g., 5-alpha reductase inhibitors) * Psychiatric conditions affecting questionnaire completion or QoL assessment * Severe comorbidities affecting QoL assessments (e.g., advanced cardiovascular disease).

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