High Risk Prostate CancerPhase 3NCT07777263
ADT De-escalation in Selected High-Risk Prostate Cancer Patients (ADaPPt Trial) a GROUQ Led PCS Study (PCS XIV)
A Phase 3 study testing ZOLADEX 10.8 mg in people with High Risk Prostate Cancer, run by Dr. Tamim Niazi at 1 site in Canada.
Trial summary
High-risk prostate cancer is usually treated with a combination of radiation therapy and hormone therapy (ADT). Radiation destroys cancer cells, while ADT lowers testosterone, a hormone that prostate cancer cells need to grow. Together, these treatments help control the cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- High Risk Prostate Cancer
- What is being tested?
- ZOLADEX 10.8 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2026to Oct 2040
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Able to understand and sign informed consent form (ICF);
- Males aged ≥ 18 years;
- Histologically confirmed adenocarcinoma of the prostate;
- Participants with high-risk prostate cancer according to either of the following:
- High-risk disease - at least one of the following: i. T3a ii. Gleason 8 or less iii. PSA ≤ 30 ng/mL
- Gleason 9 (4+5) not more than 30% of the biopsy (e.g. a 10-needle biopsy can only have a maximum of 3 x 9 [4+5]);
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- PTEN-proficient tumor confirmed by CLIA-certified immunohistochemistry (IHC);
- PSMA-PET within 90 days prior to randomization: negative for nodal or distant disease.
- Candidate for definitive radiation to prostate and pelvis;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 or Karnofsky performance status of ≥70%;
- Testosterone ≥150 ng/dL or 5 nmol/L;
- Adequate hematologic, renal, liver function (Hemoglobin ≥10 g/dL, Absolute Neutrophil Count ≥1.5x10⁹/L, Platelets ≥100x10⁹/L);
- Judged to be medically fit for ADT and RT;
- Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
- Sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation during the study treatment and for 3 months after the end of the study treatment.
Who cannot join
- • Prior local or systemic therapy for prostate cancer (e.g. ADT, chemotherapy or novel Androgen Receptor Inhibitors [ARIs]);
- PSMA-PET positive nodal or distant metastases;
- PTEN loss or equivocal by IHC (at least more than 50%);
- Evidence of nodal or distant metastases on conventional imaging;
- Prior pelvic radiation or prostate surgery interfering with RT (except biopsy/TURP);
- Life expectancy <5 years regardless of the prostate cancer;
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- Severe concurrent disease, infection, or co-morbidity that would make the patient inappropriate for enrollment (e.g. cardiovascular disease, hypertension, diabetes, etc);
- Uncontrolled cardiovascular disease including:
- Myocardial infarction within 6 months;
- Unstable angina;
- Congestive Heart Failure: New York Heart Association (NYHA) class III or IV;
- Severe arrhythmia;
- Active severe infection or immunocompromised;
- Active second malignancy within 5 years with the exception of:
- Non-melanoma skin cancer;
- Chronic Lymphocytic Leukemia (CLL) that is stable and not actively treated;
- Any condition compromising adherence to the protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Melanie Criqui, PhD, 5143408222 ext. 26771, melanie.criqui.ccomtl@ssss.gouv.qc.ca
Paola Diego, Nurse, 5143408222 ext. 24404, paola.diego.ccomtl@ssss.gouv.qc.ca
About this study
Official title: ADT De-escalation in Selected High-Risk Prostate Cancer Patients (ADaPPt Trial) a GROUQ Led PCS Study: A Phase III Trial Randomized Trial (PCS XIV)
High-risk prostate cancer is usually treated with a combination of radiation therapy and hormone therapy (ADT). Radiation destroys cancer cells, while ADT lowers testosterone, a hormone that prostate cancer cells need to grow. Together, these treatments help control the cancer.
ADT is usually given for 18 to 24 months, but it can cause side effects that may affect quality of life.
Some people with high-risk prostate cancer may do just as well with a shorter course of ADT. This study will identify people who are most likely to benefit from shorter treatment using imaging scans and tumor tests. It will then evaluate whether a shorter course of ADT works as well as the standard treatment while reducing long-term side effects.
- Conditions
- High Risk Prostate Cancer
- Being tested
- ZOLADEX 10.8 mg
- Keywords
- prostate cancer, Zoladex, Jewish General Hospital
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZOLADEX 10.8 mgDrug
The purpose of the study is to identify a subset of patient that may benefit to have a shorter Zoladex treatment (12 months vs 24 months)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (experimental): 12 months of ADT + Radiotherapy | Experimental | Zoladex is given for 12 months instead of 24 Receives: Drug: ZOLADEX 10.8 mg |
| Arm 2 (standard of care): 24 months of ADT + Radiotherapy | Active comparator | Not described Receives: Drug: ZOLADEX 10.8 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year biochemical failure-free survival (bFFS)
Time from ADT initiation to time of first occurrence of biochemical failure (per Phoenix definition: PSA nadir + 2 ng/ml)
Measured: 5 years
Secondary outcomes (10)
Metastasis-free survival
The first occurrence of distant progression or death from ADT initiation
Measured: 5-8 years
Overall survival
The time from ADT initiation to the time of death from any cause.
Measured: 5-8 years
Prostate cancer-specific mortality
The time from ADT initiation to the time of death from prostate cancer
Measured: 5-8 years
8-year biochemical failure-free survival (bFFS)
Time from ADT initiation to time of first occurrence of biochemical failure (per Phoenix definition: PSA nadir + 2 ng/ml)
Measured: 8 years
Toxicity - Acute
To determine acute toxicity due to treatment using the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0
Measured: 5 years
Toxicity - Late
To determine late toxicity due to treatment using the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0
Measured: 8 years
Quality of Life - General
Evaluate the impact of the treatment on the patient's quality of life using the FACT-P questionnaire
Measured: 5-8 years
Quality of Life - Pain
Evaluate the impact of the treatment on the patient's quality of life using the Brief Pain Inventory (BPI) questionnaire
Measured: 5-8 years
Quality of Life - Fatigue
Evaluate the impact of the treatment on the patient's quality of life using the Brief Fatigue Inventory (BFI) questionnaire
Measured: 5-8 years
Testosterone Recuperation
Time from ADT completion to the return of serum-testosterone to non-castrate or normal baseline level
Measured: 5-8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2035 (estimated)
- Study completionOct 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Tamim Niazi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Tamim Niazi, Sir Mortimer B. Davis - Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777263
- Sponsor's protocol ID
- PCSXIV (AdaPPT)
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADT De-escalation in Selected High-Risk Prostate Cancer Patients (ADaPPt Trial) a GROUQ Led PCS Study: A Phase III Trial Randomized Trial (PCS XIV)
- ClinicalTrials.gov ID
- NCT07777263
- Acronym / sponsor ID
- PCSXIV (AdaPPT)
- Conditions
- High Risk Prostate Cancer
- Keywords
- prostate cancer, Zoladex, Jewish General Hospital
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Dr. Tamim NiaziUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2035 (estimated)
- Study completion
- Oct 2040 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High-risk prostate cancer is usually treated with a combination of radiation therapy and hormone therapy (ADT). Radiation destroys cancer cells, while ADT lowers testosterone, a hormone that prostate cancer cells need to grow. Together, these treatments help control the cancer.
ADT is usually given for 18 to 24 months, but it can cause side effects that may affect quality of life.
Some people with high-risk prostate cancer may do just as well with a shorter course of ADT. This study will identify people who are most likely to benefit from shorter treatment using imaging scans and tumor tests. It will then evaluate whether a shorter course of ADT works as well as the standard treatment while reducing long-term side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (experimental): 12 months of ADT + Radiotherapy | Experimental | Drug: ZOLADEX 10.8 mgZoladex is given for 12 months instead of 24 |
| Arm 2 (standard of care): 24 months of ADT + Radiotherapy | Active comparator | Drug: ZOLADEX 10.8 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- • Able to understand and sign informed consent form (ICF);
- Gleason 9 (4+5) not more than 30% of the biopsy (e.g. a 10-needle biopsy can only have a maximum of 3 x 9 [4+5]);
- PTEN-proficient tumor confirmed by CLIA-certified immunohistochemistry (IHC);
- PSMA-PET within 90 days prior to randomization: negative for nodal or distant disease.
- Candidate for definitive radiation to prostate and pelvis;
Key exclusion criteria (17 listed)
- • Prior local or systemic therapy for prostate cancer (e.g. ADT, chemotherapy or novel Androgen Receptor Inhibitors [ARIs]);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZOLADEX 10.8 mgThe purpose of the study is to identify a subset of patient that may benefit to have a shorter Zoladex treatment (12 months vs 24 months) | Drug | Arm 1 (experimental): 12 months of ADT + Radiotherapy, Arm 2 (standard of care): 24 months of ADT + Radiotherapy |
Primary outcome
5-year biochemical failure-free survival (bFFS)
Time frame: 5 years
Time from ADT initiation to time of first occurrence of biochemical failure (per Phoenix definition: PSA nadir + 2 ng/ml)
10 secondary outcomes
Metastasis-free survival
Time frame: 5-8 years
Overall survival
Time frame: 5-8 years
Prostate cancer-specific mortality
Time frame: 5-8 years
8-year biochemical failure-free survival (bFFS)
Time frame: 8 years
Toxicity - Acute
Time frame: 5 years
Toxicity - Late
Time frame: 8 years
Quality of Life - General
Time frame: 5-8 years
Quality of Life - Pain
Time frame: 5-8 years
Quality of Life - Fatigue
Time frame: 5-8 years
Testosterone Recuperation
Time frame: 5-8 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ZOLADEX 10.8 mg in people with High Risk Prostate Cancer, run by Dr. Tamim Niazi at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mélanie Criqui, PhD (514340822 ext. 26771, melanie.criqui.ccomtl@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year biochemical failure-free survival (bFFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.