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ADT De-escalation in Selected High-Risk Prostate Cancer Patients (ADaPPt Trial) a GROUQ Led PCS Study (PCS XIV)

ConditionHigh Risk Prostate Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorDr. Tamim Niazi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Able to understand and sign informed consent form (ICF);

Males aged ≥ 18 years;

Histologically confirmed adenocarcinoma of the prostate;

PTEN-proficient tumor confirmed by CLIA-certified immunohistochemistry (IHC);

Disqualifiers

• 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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • ZOLADEX 10.8 mg

    Drug

    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)

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Arm 1 (experimental): 12 months of ADT + RadiotherapyExperimental treatment 1 intervention
Group B: Arm 2 (standard of care): 24 months of ADT + RadiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
5 years

Secondary outcomes

1

Metastasis-free survival

The first occurrence of distant progression or death from ADT initiation

Time frame
5-8 years
2

Overall survival

The time from ADT initiation to the time of death from any cause.

Time frame
5-8 years
3

Prostate cancer-specific mortality

The time from ADT initiation to the time of death from prostate cancer

Time frame
5-8 years
4

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)

Time frame
8 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Tamim Niazi

Lead sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: