ClinicalTrials.gg
Not yet recruitingNCT07460726PRIAPUS-PCaUpdated Mar 10, 2026

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

An observational study in Prostate Cancer (Adenocarcinoma), Erectile Abnormalities and Sexual Dysfunction Male, sponsored by CancerCare Manitoba. Not yet recruiting at 1 site in Canada. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-10.

Sponsored by CancerCare Manitoba · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
130
Ages
18 Years to 80 Years
Sex
Male
01

Study summary

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.

Read the detailed description

This study examines how two standard combination treatment for prostate cancer - a highly targeted form of radiation called Stereotactic Body Radiation Therapy (SBRT) and a hormone-blocking treatment called Androgen Deprivation Therapy (ADT) - impact sexual function in men with unfavorable intermediate risk prostate cancer. Participants will complete study questionnaires before treatment or Baseline, and after treatment, on Month 3, 9, 15, and 24.

02

Conditions studied

  • Prostate Cancer (Adenocarcinoma)
  • Erectile Abnormalities
  • Sexual Dysfunction Male

Keywords

  • Prostate cancer
  • sexual function
  • SBRT
  • ADT
03

In context

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

This study's planned enrollment of 130 is below the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

CancerCare Manitoba is the lead sponsor of 12 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Favorable and unfavorable intermediate risk prostate cancer patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men aged 18-80 years with -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)
  • (ECOG) performance status 0-1.
  • Written to participate.

Exclusion criteria

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)
  • to SBRT or ADT
  • disease, second , 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).
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
130 participants (estimated)
Target follow-up
24 Months
Patient registry
Yes

Groups and cohorts

  • Observational

    Prostate cancer patients receiving SBRT and ADT

    Combination Product: SBRT combined with ADT

Interventions

  • Combination productSBRT combined with ADT

    Drug page: Antiandrogens

    SBRT combined with Zoladex

06

What researchers measure

Primary outcomes

  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.

    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)

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

Secondary outcomes

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

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

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

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

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

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

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

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

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

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

    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)

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

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

    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)

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

07

Study locations

1 site
08

References and documents

Publications

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Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2026; primary completion for Mar 2028, 24 months later.

Of 541 non-industry observational studies under Prostatic Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 162. This study's planned 24 months is below that.

Counting every sponsor, half of 650 studies reached it within 60 months; a quarter within 29 and three quarters within 141.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 25, 2026
First posted
Mar 10, 2026
StartEst.
Mar 16, 2026
Primary completionEst.
Mar 16, 2028
CompletionEst.
Dec 31, 2029
Last update
Mar 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07460726
Lead sponsor
CancerCare Manitoba
Collaborators
TerSera Therapeutics LLC
Responsible party
Dr. Vibhay Pareek (Radiation Oncologist, CancerCare Manitoba) — Principal investigator
First posted
Mar 10, 2026
Start date
Mar 16, 2026 (estimated)
Primary completion
Mar 16, 2028 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Mar 10, 2026

Study contacts

Zoe Ignacio, RN, BN (BScN)
Contact
ccmb_manitoba_prostate_centre_research@cancercare.mb.ca
1-204-787-2955

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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